Partnered Programs

Our partnered pipeline includes drug candidates that we have out-licensed to leading pharmaceutical and biotechnology companies, including AstraZeneca and Allergan; and drug candidates for which we have ongoing collaboration projects, including with Pfizer, Daiichi Sankyo and MorphoSys. Our partners are developing one or more drug candidates that we discovered using our SBDD platform. We believe these strategic partnerships validate our GPCR technologies and SBDD platform capabilities, and also provide a diversified source of revenues in the form of up-front and milestone payments.

Our partnered pipeline also includes drug candidates that we are currently co-developing, or which we plan to co-develop, with collaboration partners under profit and risk-sharing arrangements. We have entered into strategic co-development agreements with Kymab and PeptiDream, for the discovery, development and commercialization of certain novel antibody therapeutics and peptides.

Partnered GPCR Pipeline Programs (Out-licensed)

PHASE 2

Adenosine A2a antagonist

CANDIDATE: AZD4635 (NCT02740985)

INDICATION: Immuno-oncology

MODALITY: Small molecule

PARTNER:


AZD4635 is a novel, potent, small molecule, adenosine A2a receptor antagonist discovered by us and licensed to AstraZeneca in 2015. The blockade of adenosine production in the tumor micro-environment is quickly emerging as one of the leading immuno-oncology treatment approaches and AZD4635 is one of the most advanced A2a receptor antagonists under investigation.

AZD4635 is in a Phase 2 clinical trial for patients with advanced solid tumors. It is being investigated as a single agent and in combination with AstraZeneca’s anti-PD-L1 antibody durvalumab (Imfinzi®).

AstraZeneca is also studying AZD4635 in a Phase 1b/2 clinical study in combination with MEDI9447 (an anti-CD73 antibody developed by MedImmune) in EGFRm non-small cell lung cancer.

The production of adenosine by tumors is a recently identified survival mechanism to evade the anti-tumor immune response. A2a receptor antagonists works by reducing the levels of adenosine in the tumor micro-environment and represent a novel mechanism that could be used as a monotherapy or in combination with a number of immunotherapy approaches to treat cancer.

AZD4635 has been designed to have a low molecular weight, good solubility and attractive drug-like properties coupled with high potency and selectivity, allowing it to be given at very high doses required to overcome the local high concentrations of adenosine.

+ Clinical Trials
- NCT02740985: A Phase 1 Clinical Study of AZD4635 and Durvalumab in Patients With Advanced Solid Malignancies

+ Press Releases

-15 April 2019: Sosei Heptares notes abstracts and posters reporting clinical and preclinical data from studies with immuno-oncology candidate AZD4635, presented by AstraZeneca at AACR 2019, are available

- 7 January 2019: Sosei Heptares to receive US$15 million milestone payment from AstraZeneca with first partnered program moving towards Phase 2
- 18 April 2018: Sosei confirms new data demonstrating AZD4635, a novel A2A receptor antagonist, induces anti-tumor immunity alone and in combination with anti-PD-L1 in preclinical models
- 8 Feb 2018: Sosei provides an update on its immuno-oncology clinical program with AstraZeneca 
- 5 April 2017: Sosei subsidiary Heptares to Receive US$12 Million Milestone Payment from AstraZeneca
- 6 Jul 2016: Initiation of Phase 1 Clinical Study with Novel Immuno-Oncology Candidate Triggers US$10 Million Milestone Payment from AstraZeneca  
- 6 Aug 2015: Sosei Subsidiary Heptares and AstraZeneca Enter Agreement to Develop Novel Immuno-Oncology Treatments for a Range of Cancers

 

+ Posters and Publications

- 15 April 2019: Evidence of immune activation in the first-in-human Phase 1a dose escalation study of AZD4635 in patients with advanced solid tumors

15 April 2019: The A2AR antagonist AZD4635 prevents adenosine-mediated immunosuppression of CD103+ dendritic cells

-18 April 2018: “Inhibition of A2AR by AZD4635 induces anti-tumor immunity alone and in combination with anti-PD-L1 in preclinical models ” – 2018 AACR Meeting
- 26 March 2018: “Optimism for A2A” – BioCentury 
- 8 Jan 2018: Towards high throughput GPCR crystallography: In Meso soaking of Adenosine A2A Receptor crystals
- 1 Jan 2018: Structural Mapping of Adenosine Receptor Mutations: Ligand Binding and Signaling Mechanisms 
- 20 Nov 2017: Impact of protein–ligand solvation and desolvation on transition state thermodynamic properties of adenosine A2A ligand binding kinetics
- 5 April 2017: Preclinical pharmacodynamics and antitumor activity of AZD4635, a novel adenosine 2A receptor inhibitor that reverses adenosine mediated T cell suppression 
- 22 June 2016: Structurally Enabled Discovery of Adenosine A2A Receptor Antagonists
- 17 June 2016: Controlling the Dissociation of Ligands from the Adenosine A2A Receptor through Modulation of Salt Bridge Strength
- 21 Jan 2014: Structure-based drug design of chromone antagonists of the adenosine A2A receptor
- 1 June 2013: Water Network Perturbation in Ligand Binding: Adenosine A2A Antagonists as a Case Study
- 19 Feb 2013: Pharmacology and Structure of Isolated Conformations of the Adenosine A2A Receptor Define Ligand Efficacy
- 11 Sep 2012: Stabilised G protein-coupled receptors in structure-based drug design: a case study with adenosine A2A receptor
- 26 Sep 2012: Fragment Screening of GPCRs Using Biophysical Methods: Identification of Ligands of the Adenosine A2A Receptor with Novel Biological Activity
- 17 Jan 2012: Identification of Novel Adenosine A2A Receptor Antagonists by Virtual Screening
- 5 Jan 2012: Discovery of 1,2,4-Triazine Derivatives as Adenosine A2A Antagonists using Structure Based Drug Design
- 14 Jun 2011: Structure of the Adenosine A2A Receptor in Complex with ZM241385 and the Xanthines XAC and Caffeine
- 10 Jun 2011: Biophysical Mapping of the Adenosine A2A Receptor
- 23 Jun 2011: Agonist-bound adenosine A2A receptor structures reveal common features of GPCR activation
- 10 Jun 2011: Thermostabilisation of an Agonist-Bound Conformation of the Human Adenosine A2A Receptor

 

 

PHASE 1b

Adenosine A2a antagonist

CANDIDATE: AZD4635 (NCT03381274)

INDICATION: Immuno-oncology

MODALITY: Small molecule

PARTNER:


AZD4635 is a novel, potent, small molecule, adenosine A2a receptor antagonist discovered by us and licensed to AstraZeneca in 2015. The blockade of adenosine production in the tumor micro-environment is quickly emerging as one of the leading immuno-oncology treatment approaches and AZD4635 is one of the most advanced A2a receptor antagonists under investigation.

AZD4635 is in a Phase 2 clinical trial for patients with advanced solid tumors. It is being investigated as a single agent and in combination with AstraZeneca’s anti-PD-L1 antibody durvalumab (Imfinzi®).

AstraZeneca is also studying AZD4635 in a Phase 1b/2 clinical study in combination with MEDI9447 (an anti-CD73 antibody developed by MedImmune) in EGFRm non-small cell lung cancer.

The production of adenosine by tumors is a recently identified survival mechanism to evade the anti-tumor immune response. A2a receptor antagonists works by reducing the levels of adenosine in the tumor micro-environment and represent a novel mechanism that could be used as a monotherapy or in combination with a number of immunotherapy approaches to treat cancer.

AZD4635 has been designed to have a low molecular weight, good solubility and attractive drug-like properties coupled with high potency and selectivity, allowing it to be given at very high doses required to overcome the local high concentrations of adenosine.

+ Clinical Trials
- NCT03381274: Oleclumab (MEDI9447) EGFRm NSCLC Novel Combination Study

 

+ Press Releases

- 15 April 2019: Sosei Heptares notes abstracts and posters reporting clinical and preclinical data from studies with immuno-oncology candidate AZD4635, presented by AstraZeneca at AACR 2019, are available
- 7 January 2019: Sosei Heptares to receive US$15 million milestone payment from AstraZeneca with first partnered program moving towards Phase 2
- 18 April 2018: Sosei confirms new data demonstrating AZD4635, a novel A2A receptor antagonist, induces anti-tumor immunity alone and in combination with anti-PD-L1 in preclinical models
- 8 Feb 2018: Sosei provides an update on its immuno-oncology clinical program with AstraZeneca 
- 5 April 2017: Sosei subsidiary Heptares to Receive US$12 Million Milestone Payment from AstraZeneca
- 6 Jul 2016: Initiation of Phase 1 Clinical Study with Novel Immuno-Oncology Candidate Triggers US$10 Million Milestone Payment from AstraZeneca  
- 6 Aug 2015: Sosei Subsidiary Heptares and AstraZeneca Enter Agreement to Develop Novel Immuno-Oncology Treatments for a Range of Cancers

+ Posters and Publications

- 15 April 2019: Evidence of immune activation in the first-in-human Phase 1a dose escalation study of AZD4635 in patients with advanced solid tumors

- 15 April 2019: The A2AR antagonist AZD4635 prevents adenosine-mediated immunosuppression of CD103+ dendritic cells
- 18 April 2018: “Inhibition of A2AR by AZD4635 induces anti-tumor immunity alone and in combination with anti-PD-L1 in preclinical models ” – 2018 AACR Meeting
- 26 March 2018: “Optimism for A2A” – BioCentury 
- 8 Jan 2018: Towards high throughput GPCR crystallography: In Meso soaking of Adenosine A2A Receptor crystals
- 1 Jan 2018: Structural Mapping of Adenosine Receptor Mutations: Ligand Binding and Signaling Mechanisms 
- 20 Nov 2017: Impact of protein–ligand solvation and desolvation on transition state thermodynamic properties of adenosine A2A ligand binding kinetics
- 5 April 2017: Preclinical pharmacodynamics and antitumor activity of AZD4635, a novel adenosine 2A receptor inhibitor that reverses adenosine mediated T cell suppression 
- 22 June 2016: Structurally Enabled Discovery of Adenosine A2A Receptor Antagonists
- 17 June 2016: Controlling the Dissociation of Ligands from the Adenosine A2A Receptor through Modulation of Salt Bridge Strength
- 21 Jan 2014: Structure-based drug design of chromone antagonists of the adenosine A2A receptor
- 1 June 2013: Water Network Perturbation in Ligand Binding: Adenosine A2A Antagonists as a Case Study
- 19 Feb 2013: Pharmacology and Structure of Isolated Conformations of the Adenosine A2A Receptor Define Ligand Efficacy
- 11 Sep 2012: Stabilised G protein-coupled receptors in structure-based drug design: a case study with adenosine A2A receptor
- 26 Sep 2012: Fragment Screening of GPCRs Using Biophysical Methods: Identification of Ligands of the Adenosine A2A Receptor with Novel Biological Activity
- 17 Jan 2012: Identification of Novel Adenosine A2A Receptor Antagonists by Virtual Screening
- 5 Jan 2012: Discovery of 1,2,4-Triazine Derivatives as Adenosine A2A Antagonists using Structure Based Drug Design
- 14 Jun 2011: Structure of the Adenosine A2A Receptor in Complex with ZM241385 and the Xanthines XAC and Caffeine
- 10 Jun 2011: Biophysical Mapping of the Adenosine A2A Receptor
- 23 Jun 2011: Agonist-bound adenosine A2A receptor structures reveal common features of GPCR activation
- 10 Jun 2011: Thermostabilisation of an Agonist-Bound Conformation of the Human Adenosine A2A Receptor

 

 

PHASE 1b (voluntarily suspended)

Muscarinic M1 agonist

CANDIDATE: HTL0018318

INDICATION: Alzheimer’s disease

MODALITY: Small molecule

PARTNER:


HTL0018318 is a first-in-class, selective small molecule muscarinic M1 receptor agonist in clinical development as a potential new symptomatic treatment of cognition in neurodegenerative disorders, principally Alzheimer’s disease. HTL0018318 works through the cholinergic pathway but has a different mechanism of action than available acetyl-cholinesterase inhibitors.

HTL0018318 was designed to be selective for M1 receptors and to avoid unwanted side effects and off-target binding seen with previous poorly selective muscarinic agonists, such as xanomeline.

HTL0018318 completed a Phase 1b patient study conducted and sponsored by us to evaluate its safety, tolerability, pharmacokinetics and pharmacodynamics as an adjunct to standard cholinesterase inhibitor therapy (donepezil) in patients with mild to moderate Alzheimer’s disease.

In September 2018, we, together with Allergan, decided to voluntarily suspend clinical development activities with HTL0018318 pending the investigation of an unexpected toxicology finding in an animal study involving non-human primates.

+ Clinical Trials
- NCT02958696: Relative Bioavailability of HTL0018318 Oral Aqueous Solution Versus Capsules
- NCT03592862: A Study to Assess Safety, Tolerability, and Efficacy of HTL0018318 in Patients With Dementia With Lewy Bodies (DLB) 
- NCT03198624: Pharmacokinetics of Oral Capsule in Healthy Japanese vs. Caucasian Subjects (HTL0018318)
- NCT03456349: Multi-centre Study of HTL0018318 in Patients as an add-on to Standard-of-care

+ Press Releases
- 18 Sep 2018: Sosei Provides Update on HTL0018318
- 9 Nov 2017: Sosei to Advance Clinical Development in Japan of HTL0018318 in Patients with Dementia with Lewy Bodies
- 7 Apr 2016: Sosei Subsidiary Heptares and Allergan Announce Global R&D and Commercialization Partnership for Novel Treatments in Alzheimer’s and Other Neurological Disorders
- 10 Feb 2016: Sosei subsidiary Heptares announces positive results from Phase 1b clinical trial with HTL9936, a first-in-class selective muscarinic M1 receptor agonist for improving cognition in dementia and schizophrenia
- 17 Jun 2015: Sosei subsidiary Heptares announces positive outcome of Phase 1a study with first-ever selective muscarinic M1 receptor agonist for improving cognition in patients with Alzheimer’s disease

PHASE 1

Muscarinic M4 agonist

CANDIDATE: HTL0016878

INDICATION: Alzheimer’s disease

MODALITY: Small molecule

PARTNER:


HTL0016878 is a first-in-class, selective and orally available, small molecule muscarinic M4 receptor agonist being advanced through clinical development as a potential new treatment for neurobehavioural symptoms associated with Alzheimer’s disease. HTL0016878 has been designed to work through a different mechanism of action than available antipsychotics. The high selectivity of HTL0016878 offers the possibility for an improved safety profile over previous non-selective muscarinic receptor agonists.

HTL0016878 is in a Phase 1 double-blind, randomized first-in-human clinical study being conducted in the U.K. by us and funded by Allergan to assess safety, tolerability and pharmacokinetics of single and multiple oral doses of HTL0016878 in healthy volunteers.

+ Clinical Trials
- NCT03244228: A Two Part Study to Assess Safety, PK, PD, and Food Effect of Oral HTL0016878 

+ Press Releases
- 1 Sep 2017: First Subject Dosed in Phase 1 Clinical Study of Novel Selective Muscarinic M4 Agonist in Development to Treat Major Symptoms of Alzheimer’s Disease
- 7 Apr 2016: Sosei Subsidiary Heptares and Allergan Announce Global R&D and Commercialization Partnership for Novel Treatments in Alzheimer’s and Other Neurological Disorders

 

Preclinical

Dual Muscarinic M1/M4 agonists

INDICATION: Alzheimer’s disease

MODALITY: Small molecule

PARTNER:


Together with our partner Allergan, we are advancing a series of selective, small molecule, dual M1/M4 agonists through preclinical development. Such molecules have the potential to treat both cognitive impairment and neurobehavioral symptoms associated with Alzheimer’s disease and other neurological diseases.

+ Press Releases
- 7 April 2016: Allergan and Heptares Announce Global R&D and Commercialization Partnership for Novel Treatments in Alzheimer’s and Other Neurological Disorders

 

Discovery

Pfizer Collaboration

INDICATION: Multiple therapeutic areas

MODALITY: Small molecule and monoclonal antibody

PARTNER:


Sosei Heptares Group and Pfizer initiated a strategic drug discovery collaboration in 2015 to research and develop potential new medicines directed at up to 10 GPCR targets nominated by Pfizer in multiple therapeutic areas. The nominated targets have strong clinical and biological validation as key points for therapeutic intervention in their respective diseases but have proved very challenging to address with conventional discovery approaches, with sub-optimal or no medicines approved to date.

Since the start of the collaboration we have delivered multiple preclinical milestones, including StaR®s, X-ray structures and lead molecules, as well as new intellectual property. 

+ Press Releases

- 14 May 2019: Sosei Heptares reports progress with Pfizer as multi-target collaboration delivers first candidate for clinical advancement

- 30 Nov 2015: Heptares Enters Strategic Drug Discovery Collaboration with Pfizer Inc. focused on GPCR Targets across Multiple Therapeutics Areas



Discovery

Daiichi-Sankyo Collaboration

INDICATION: Pain

MODALITY: Small molecule

PARTNER:


Sosei Heptares Group and Daiichi Sankyo are collaborating to design novel, small molecules focused on GPCRs nominated by Daiichi Sankyo. These GPCRs play a crucial role in relieving pain. The programme is in discovery phase.

+ Press Releases
- 13 March 2017: Sosei subsidiary Heptares and Daiichi Sankyo to Discover and Develop Novel, Small-Molecules for the Treatment of Pain



Discovery

Morphosys Collaboration

INDICATION: Not disclosed

MODALITY: Monoclonal antibody

PARTNER:


Sosei Heptares Group and Morphosys are collaborating to discover and develop novel antibody candidates targeting a defined set of GPCR targets proposed by MorphoSys.

Sosei Heptares is also progressing a therapeutic antibody programme targeting Protease activated receptor 2 (PAR2) arising from its alliance with Morphosys.

+ Press Releases
- 30 July 2015: Sosei subsidiary Heptares Initiates Proprietary Therapeutic Antibody Program against a GPCR Target

 

Partnered GPCR Pipeline Programs (Profit share/Co-development)

Discovery

Novel Peptide Therapeutics

INDICATION: Inflammation

MODALITY: Peptide

PARTNER:


In 2017, Sosei Heptares Group and PeptiDream entered into a strategic collaboration to discover, develop and commercialize novel therapeutics targeting Protease activated receptor 2 (PAR2), a GPCR that plays an important role in inflammatory diseases.

The collaboration brings together two drug discovery platforms and preclinical and clinical development capabilities. We will apply our StaR® platform and resulting 3D structural insights to the GPCR target selected by both companies. PeptiDream will use its proprietary Peptide Discovery Platform System (PDPS) technology to identify macrocyclic/constrained peptides against the target GPCR and to optimize hit peptides and/or small molecules for further development. Promising leads will be progressed using the partners’ complementary skills, resources and development capabilities in order to bring innovative products into the clinic. Under the agreement, the companies will jointly conduct and share the costs of the discovery and development program and will co-own any resulting products.

+ Press Releases
- 24 May 2018: Sosei collaboration with PeptiDream progressing well - Peptide antagonists with high affinity and selectivity against PAR2 target identified
- 29 Jun 2017: Sosei Subsidiary Heptares and PeptiDream Enter Strategic Collaboration to Discover, Develop & Commercialise Novel Therapeutics in Inflammatory Disease

 

 

Preclinical

CXCR4 mAb

CANDIDATE: KY1051

INDICATION: Immuno-oncology

MODALITY: Monoclonal antibody

PARTNER:


In 2016, Sosei Heptares Group and Kymab entered into a strategic collaboration to discover, develop and commercialize novel antibody therapeutics targeting a number of GPCRs with an initial focus on immuno-oncology. KY1051 CXCR-4 product candidate is the first program governed by the terms of the Collaboration Agreement.

GPCRs are widely expressed on cells of the innate and adaptive immune system and play key roles in modulating cell migration and recruitment to the tumor environment, activation, survival, proliferation and differentiation. GPCRs act at critical checkpoints that can be targeted by novel immunotherapy antibodies.

Under the agreement, we will apply our StaR® platform to create stable antigens based on multiple GPCR targets chosen by the companies. Kymab will then use its IntelliSelect™ Transgenic platform to generate antibodies in response to immunization with these antigens. Promising leads will be progressed using the partners’ complementary skills, resources and development capabilities in order to bring innovative products into the clinic. Under the agreement, the companies will jointly conduct and share the costs of each antibody discovery and development program.

KY1051 is an antibody that binds CXCR4, a chemokine receptor that plays a key role in modulating the immune system and the tumour microenvironment. KY1051 neutralizes the binding of CXCR4 to its ligand CXCL12, which we believe will allow treatment in combination with immune-checkpoint therapies in a wide range of malignancies.

+ Press Releases
- 18 April 2016: Sosei Subsidiary Heptares and Kymab enter strategic collaboration to discover, development and commercialize novel antibody therapeutics

Discovery

Novel Antibody Therapeutics

CANDIDATE: KY1062

INDICATION: Immuno-oncology

MODALITY: Monoclonal antibody

PARTNER:


In 2016, Sosei Heptares Group and Kymab entered into a strategic collaboration to discover, develop and commercialize novel antibody therapeutics targeting a number of GPCRs with an initial focus on immuno-oncology.

GPCRs are widely expressed on cells of the innate and adaptive immune system and play key roles in modulating cell migration and recruitment to the tumor environment, activation, survival, proliferation and differentiation. GPCRs act at critical checkpoints that can be targeted by novel immunotherapy antibodies.

Under the agreement, we will apply our StaR® platform to create stable antigens based on multiple GPCR targets chosen by the companies. Kymab will then use its Kymouse™ human antibody discovery platform to generate antibodies in response to immunization with these antigens. Promising leads will be progressed using the partners’ complementary skills, resources and development capabilities in order to bring innovative products into the clinic. Under the agreement, the companies will jointly conduct and share the costs of each antibody discovery and development program.

+ Press Releases
- 18 April 2016: Sosei Subsidiary Heptares and Kymab enter strategic collaboration to discover, development and commercialise novel antibody therapeutics

Asset-centric Companies

Discovery

Orexia Limited

INDICATION: Narcolepsy

MODALITY: Small molecule

COMPANY:


Orexia Limited aims to develop orally administered orexin positive modulators for the treatment of neurological diseases.

The orexin system is a key regulator of behavioral arousal, wakefulness and sleep. The loss of the orexin neurons has been shown to be strongly linked to multiple neurological conditions including narcolepsy. In this indication, orexin receptors remain intact and functional, providing an opportunity for therapeutic intervention.

The primary target indication of narcolepsy is characterized by frequent transitions between states of wakefulness and sleep and the inability of maintaining a wakeful state. Narcoleptic patients experience excessive daytime sleepiness (EDS), manifesting as attacks of falling asleep at unpredictable times, as well as often suffering from cataplexy, a sudden debilitating but transient weakening of muscle tone that can cause sufferers to collapse. An orexin positive modulator will aim to restore orexin levels in the brain and improve symptoms.

The company is founded by Medicxi in collaboration with Sosei Heptares and follows the asset centric model of outsourcing R&D activities. The partnership with Sosei Heptares leverages unique GPCR structure-based drug design (SBDD) capability for the discovery and development of promising drug candidates. 

+ Press Releases

- 12 Feb 2019: Collaboration deal with Medicxi - Supplementary Material

- 4 Feb 209: Collaboration deal with Medicxi Presentation

- 4 Feb 2019: Sosei Heptares announces Medicxi to invest up to €40 million in new collaboration based on its orexin agonist program

Discovery

Inexia Limited

INDICATION: Narcolepsy

MODALITY: Small molecule

COMPANY:


Inexia aims to develop intranasally administered orexin positive modulators for the treatment of neurological diseases.

The orexin system is a key regulator of behavioural arousal, wakefulness and sleep. The loss of the orexin neurons has been shown to be strongly linked to multiple neurological conditions including narcolepsy. In this indication, orexin receptors remain intact and functional, providing an opportunity for therapeutic intervention.

The primary target indication of narcolepsy is characterized by frequent transitions between states of wakefulness and sleep and the inability of maintaining a wakeful state. Narcoleptic patients experience excessive daytime sleepiness (EDS), manifesting as attacks of falling asleep at unpredictable times, as well as often suffering from cataplexy, a sudden debilitating but transient weakening of muscle tone that can cause sufferers to collapse. An orexin positive modulator will aim to restore orexin levels in the brain and improve symptoms.

The company is founded by Medicxi in collaboration with Sosei Heptares and Optinose, and follows the asset centric model of outsourcing R&D activities. The partnership with Sosei Heptares leverages unique GPCR structure-based drug design (SBDD) capability for the discovery and development of promising drug candidates which will be delivered using Optinose’s unique clinically validated intranasal Exhalation Delivery System (EDS).

+ Press Releases

- 12 Feb 2019: Collaboration deal with Medicxi - Supplementary Material

- 4 Feb 2019: Collaboration deal with Medicxi Presentation

- 4 Feb 2019: Sosei Heptares announces Medicxi to invest up to €40 million in new collaboration based on its orexin agonist program 

Other Partnered Pipeline Programs

PHASE 3

New Inhaled Therapy

CANDIDATE: QVM149

INDICATION: Asthma

MODALITY: Small molecule

PARTNER:


QVM 149 is a fixed dose, once daily combination of the long-acting muscarinic antagonist (LAMA) glycopyrronium bromide, the long-acting beta agonist (LABA) indacaterol, and the inhaled corticosteroid (ICS) mometasone furoate.

Having identified a new use for glycopyrronium bromide for chronic obstructive pulmonary disease (COPD), Sosei Heptares re-profiled it as an inhaled formulation, and together with Vectura, we licensed exclusive worldwide development and marketing rights to Novartis in 2005. Under the terms of the agreement with Novartis, we are eligible to receive developmental milestones and fixed-rate royalties on worldwide product sales of any compound containing glycopyrronium bromide.

QVM 149 is currently in Phase 3 development by Novartis. Data have confirmed that QVM 149 significantly decreases breathlessness and improves lung function and overall quality of life. Novartis has confirmed it will commence filing for QVM149 in 2019.

Asthma is a chronic disease that affects lung air passages. Asthma is characterized by variable symptoms of wheeze, shortness of breath, chest tightness and/or cough and by variable expiratory airflow limitation. In many patients, symptoms may resolve spontaneously or in response to medication, however continued exposure to allergens may lead to worsening of symptoms. The Global Strategy for Asthma Management and Prevention suggests that persistent symptoms may trigger inflammatory responses in the airways and can deteriorate the condition. WHO estimates that 235 million people currently suffer from asthma and that it is the most common disease among children.

+ Clinical Trials
- NCT03100825: A Long-term Safety Study of QVM149 in Japanese Patients With Asthma
- NCT03108027: Assess Bronchodilator Effect QVM149 Dosed Either in the Morning or Evening Compared to Placebo in Patients With Asthma (QVM149)
- NCT03158311: Study to Compare QVM149 and Free Triple Combination of Salmeterol/Fluticasone + Tiotropium (ARGON)
- NCT03063086: Assess Bronchodilator Effect and Safety of Two Doses of QVM149 Compared to a Fixed Dose Combination of Salmeterol/Fluticasone in Patients With Asthma.
- NCT02571777: Study to Compare the Efficacy and Safety of QVM149 With QMF149 in Patients With Asthma

+ Press Releases

- 24 May 2019 Sosei Heptares notes that a valid Marketing Authorization Application for QVM149, a potential new inhaled combination therapy for asthma, has been filed with the European Medicines Agency

- 22 May 2019: Sosei Heptares notes new positive Phase II data for QVM149, a potential novel inhaled combination for treating asthma, were presented at      ATS 2019
- 9 Dec 2015: Commencement of First Phase III Trial of Inhaled Triple Therapy QVM149 for Asthma
- 18 Jun 2015: Planned development of inhaled triple therapy QVM149 for asthma