NXERA CONTEMPLATIVE RIBBONS 2 8 K

We have a broad pipeline of novel drugs that have potential to become first-in-class or best-in-class medicines for a range of diseases.

We are developing molecules both in-house and with partners to ensure that our medicines have the best chances of reaching patients in need.

Daridorexant is a dual orexin receptor antagonist that blocks the binding and activity of the wake-promoting neuropeptides known as orexins. In October 2022, daridorexant achieved positive Phase 3 top-line results in Japanese patients with insomnia and a New Drug Application was submitted in Japan in October 2023. Daridorexant is approved in the US and Europe and marketed in these territories under the brand name QUVIVIQ™ by Idorsia. Nxera Pharma has the Japanese and APAC (ex-China) rights for daridorexant.

Daridorexant

Nxera Pharma is advancing a GPR52 agonist as a potential therapy to address positive symptoms, negative symptoms and cognitive impairment in schizophrenia and other psychosis disorders, without adverse effects typically associated with antipsychotics.
NXE'149 entered a Phase 1 clinical trial in July 2023 and is expected to read-out initial data in late 2024. The clinical trial ID is: <a href="https://www.isrctn.com/ISRCTN17231793" target="_blank" rel="noreferrer noopener">ISRCTN17231793</a>

GPR52 agonist

Cancer Research UK

Nxera Pharma is advancing a novel, highly selective and potent antagonist of the EP4 receptor to mediate PGE2 immunosuppression in the tumor microenvironment within oncology.
In July 2022, Nxera Pharma and Cancer Research UK signed an agreement to bring Nxera’s cancer immunotherapy drug candidate into a first-in-human trial. 
Under the Clinical Trial and Licence Agreement (CTLA), Cancer Research UK’s Centre for Drug Development will sponsor, design and execute a Phase 1/2a clinical trial of NXE'732. 
The trial was initiated in August 2023. The clinicaltrials.gov ID is <a href="https://clinicaltrials.gov/study/NCT05944237?cond=NCT05944237&amp;rank=1" target="_blank" rel="noreferrer noopener">NCT05944237</a>

EP4 antagonist

Nxera Pharma is developing an oral small molecule EP4 agonist for the treatment of IBD. The prostaglandin EP4 receptor has been identified as a candidate susceptibility gene for IBD and plays a critical role in maintaining barrier homeostasis. 
NXE'744 is a potent, selective and gut-restricted EP4 agonist that has been uniquely designed to bring clinical benefit by accelerating the healing of damaged epithelial mucosa and suppressing exaggerated gut inflammation, with minimal systemic exposure to avoid adverse events. 
NXE'744 entered a Phase 1 clinical trial in March 2024 for the treatment of IBD. Initial data read-outs are anticipated from 2025.

EP4 agonist

In November 2021, Neurocrine Biosciences and Nxera Pharma entered into a strategic collaboration and licensing agreement to develop novel muscarinic receptor agonists, which Neurocrine Biosciences intends to study in the treatment for schizophrenia, dementia and other neuropsychiatric disorders.
 
NBI-1117567 is a muscarinic M1-preferring agonist that may have the potential to treat neurological and neuropsychiatric conditions and a Phase 1 study of NBI-1117567 will be initiated in 2024. 
Nxera Pharma retains the rights to develop M1 agonists in Japan in all indications, with Neurocrine Biosciences receiving co-development and profit share options.

Muscarinic M1-preferring agonist (Japan)

NXE0027477 (formerly GSK4381406) was designed by Nxera Pharma using our NxWave platform and licensed to GSK in 2020. Since then, Nxera Pharma and GSK have advanced NXE'477 through a joint development program, generating promising mechanistic, preclinical and safety data suggesting that it may have the potential to improve barrier function and reduce visceral pain in gastrointestinal indications such as ulcerative colitis and irritable bowel syndrome. 
These data enabled Nxera Pharma and GSK to gain approval from the UK MHRA in mid-2023 to enter NXE'477 into first-in-human studies (NCT05999708). 
Nxera Pharma regained full ownership of the NXE'477 program in March 2024.

GPR35 agonist

Our emerging pipeline of in-house programs comprise multiple drug candidates that address patient populations across our key focus areas of neurology, GI and immunology, metabolic disorders and rare diseases.

Neurocrine Biosciences

In November 2021, Neurocrine Biosciences and Nxera Pharma entered into a strategic collaboration and licensing agreement to develop novel muscarinic receptor agonists, which Neurocrine Biosciences intends to study in the treatment for schizophrenia, dementia and other neuropsychiatric disorders. 
NBI-1117568 is an oral, selective muscarinic M4 receptor agonist in development for the treatment of schizophrenia and other neuropsychiatric disorders. NBI-1117568 is in a Phase 2 trial assessing the efficacy, safety, tolerability, and pharmacokinetics in patients with schizophrenia. The clinicaltrials.gov ID is: <a href="https://clinicaltrials.gov/study/NCT05545111?term=NBI-1117568&amp;rank=1" target="_blank" rel="noreferrer noopener">NCT05545111</a>

Muscarinic M4 agonist

Pfizer

Nxera Pharma 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.
PF-07054894 is currently in a Phase 1b clinical trial evaluating the safety, efficacy and pharmacokinetics in patients with Ulcerative Colitis. The clinicaltrials.gov ID is: <a href="https://clinicaltrials.gov/study/NCT05549323" target="_blank" rel="noreferrer noopener">NCT05549323</a>

CCR6 antagonist

Nxera Pharma 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.
PF-07258669 has been assessed in two Phase 1 trials of healthy adult participants to evaluate safety, tolerability and pharmacokinetics.

MC4 antagonist

Nxera Pharma 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.
PF-06954522 is currently in a Phase 1 clinical trial evaluating the safety, efficacy and pharmacokinetics in healthy participants. The clinicaltrials.gov ID is:<a href="https://classic.clinicaltrials.gov/ct2/show/NCT06003777"> NCT06003777</a>

GLP-1 agonist

In November 2021, Neurocrine Biosciences and Nxera Pharma entered into a strategic collaboration and licensing agreement to develop novel muscarinic receptor agonists, which Neurocrine Biosciences intends to study in the treatment for schizophrenia, dementia and other neuropsychiatric disorders. 
NBI-1117570 is an investigational, oral, muscarinic M1/M4 selective dual agonist that may have the potential to treat neurological and neuropsychiatric conditions and was developed utilising Nxera Pharma's NxWave SBDD platform.
In September 2023, Neurocrine Biosciences initiated a Phase 1 first-in-human clinical study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of NBI-1117570 in healthy adult participants.

Dual Muscarinic M1/M4 agonist

In November 2021, Neurocrine Biosciences and Nxera Pharma entered into a strategic collaboration and licensing agreement to develop novel muscarinic receptor agonists, which Neurocrine Biosciences intends to study in the treatment for schizophrenia, dementia and other neuropsychiatric disorders. 
NBI-1117569 is a muscarinic M4-preferring agonist which may have the potential to treat neurological and neuropsychiatric conditions and was developed utilizing Nxera Pharma's SBDD platform.

Muscarinic M4-preferring agonist

Tempero Bio

In November 2020, Nxera Pharma entered into an agreement with Tempero Bio, under which Tempero Bio has in-licensed exclusive global rights to Nxera Pharma’s mGlu5-NAM program to develop therapies targeting substance use disorders and anxiety. TMP-301 is a potent and selective mGlu5 small molecule negative-allosteric modulator (NAM) discovered by Nxera as a potential treatment for certain neurological orders. 
In January 2023, Tempero Bio received FDA clearance to advance the clinical development of TMP-301 for the treatment of alcohol and substance use disorders.

mGlu5 NAM

In November 2021, Neurocrine Biosciences and Nxera Pharma entered into a strategic collaboration and licensing agreement to develop novel muscarinic receptor agonists, which Neurocrine Biosciences intends to study in the treatment for schizophrenia, dementia and other neuropsychiatric disorders.
NBI-1117569 is a muscarinic M4-preferring agonist which may have the potential to treat neurological and neuropsychiatric conditions and was developed utilizing Nxera Pharma's NxWave SBDD platform. 
Nxera Pharma retains the rights to develop M1 agonists in Japan in all indications, with Neurocrine Biosciences receiving co-development and profit share options.

Muscarinic M1 agonist

Sanofi

Nxera Pharma and Kymab (now part of Sanofi) 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, a CXCR-4 product candidate is the first program from this collaboration.

CXCR4 mAb

Centessa Pharmaceuticals

Orexia Therapeutics is a subsidiary of Centessa Pharmaceuticals, a novel asset-centric pharmaceutical company designed and built to advance a portfolio of highly validated programs.
Orexia Therapeutics is developing oral and intranasal orexin receptor agonists under two discovery programs using structure-based drug design approaches. ORX750 is an investigational, orally administered, highly potent and selective orexin receptor 2 (OX2R) agonist designed to directly target the underlying pathophysiology of orexin neuron loss in narcolepsy type 1 (NT1).

OX2 agonist

Genentech

Nxera Pharma and Genentech, a member of the Roche Group, signed a multi-target research collaboration and license agreement with Genentech in 2019 to discover and develop novel medicines (new small molecules and/or biologics) that modulate multiple GPCR targets of interest to Genentech. The nominated targets represent promising new therapeutic intervention points across a range of diseases.
Genentech is advancing a potential first-in-class project targeting an undisclosed GPCR and is responsible for further development and commercialization of this potential new medicine.

Genentech Collaboration

Takeda

Nxera Pharma announced a strategic multi-target partnership with Takeda in 2019 to discover, develop and commercialize novel molecules, including small molecules and biologics, that modulate GPCR targets of interest to Takeda. The nominated targets represent new therapeutic intervention points across a range of diseases.
In February 2022, Takeda nominated a new disease target under the partnership resulting in an undisclosed milestone payment.

Takeda Collaboration

AbbVie

In August 2022, Nxera Pharma signed a multi-target collaboration with AbbVie targeting neurological diseases.

AbbVie Collaboration

Lilly

In December 2022, Nxera Pharma entered a drug discovery collaboration with Lilly to discover, develop and commercialize small molecules that modulate novel GPCR targets associated with diabetes and metabolic diseases. 
Under the terms of the agreement, Nxera will focus its efforts on multiple GPCR targets nominated by Lilly to deliver novel target-selective small molecule hit candidates for further development and commercialization.

Lilly Collaboration

PeptiDream

Nxera Pharma and PeptiDream are collaborating to discover, develop and commercialize novel therapeutics targeting Protease activated receptor 2 (PAR2), a GPCR that plays an important role in inflammatory diseases.
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.

PAR2 peptide

Verily

In January 2022, Nxera Pharma entered into a research collaboration with Verily to combine Verily's Immune Profiler and Nxera's NxStar platform to generate novel drug candidates against GPCR targets for immune-mediated diseases.
In October 2023, Nxera and Verily nominated the first GPCR target for therapeutic development.

AI Augmented Drug Discovery

Pharmenable

In January 2021, Nxera Pharma and PharmEnable, a UK drug discovery company, entered a collaboration to apply their respective technologies to drive novel drug discovery against a challenging GPCR target associated with neurological diseases.
In October 2023, Nxera and PharmEnable expanded their collaboration to drive novel drug discovery for a second neurological disease target.

Kallyope

In May 2022, Nxera Pharma and Kallyope entered a strategic research collaboration to identify and validate novel GPCR targets with a goal of creating new drug discovery programs in the area of gastrointestinal diseases. 
In November 2023, Nxera and Kallyope nominated the first GPCR target for therapeutic development in gastrointestinal diseases.

Gut-brain axis drug discovery

We have a diverse pipeline advancing through partnerships with a range of pharma and emerging technology companies, using a range of strategies including traditional out-licensing, option-to-license and profit-share collaborations.