In-house Programs

Our emerging pipeline of in-house programs comprises drug candidates advancing through various stages of early development and preclinical studies with a focus on core therapeutic areas including neurology, gastro-intestinal, inflammatory and other indications. Our plan is to advance only the highest quality programs from our proprietary pipeline to clinical development, with the intent to eventually commercialize selected products in designated markets ourselves.

Preclinical

H4 antagonist

INDICATION: Atopic dermatitis

MODALITY: Small molecule

WHOLLY-OWNED BY:


Sosei Heptares is advancing a novel small molecule H4 receptor antagonist for the treatment of atopic dermatitis (AD). The H4 receptor is a clinically validated target in AD and pruritis (itch) and our preclinical studies to date with our leading candidate demonstrate efficacy in human primary immune cells and an excellent safety profile in early toxicology studies.

Preclinical

EP4 antagonist

INDICATION: Immuno-oncology

MODALITY: Small molecule

WHOLLY-OWNED BY:


Sosei Heptares 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, Sosei Heptares and Cancer Research UK signed an agreement to bring Sosei Heptares’ 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 I/IIa clinical trial of HTL00397322, a novel selective EP4 antagonist.

Sosei Heptares will be responsible for CTA enabling activities, including GLP toxicology, IMP manufacture1 and other necessary pre-clinical studies in preparation for the opening of the clinical trial. Sosei Heptares holds a licence to the results generated under the trial to continue the clinical development and commercialisation of HTL0039732. 

 

+ Press Releases

Preclinical

GPR52 agonist

INDICATION: Neurology diseases

MODALITY: Small molecule

WHOLLY-OWNED BY:


Sosei Heptares 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.

Discovery

PAR2 mAb

INDICATION: Atopic dermatitis

MODALITY: Monoclonal antibody

WHOLLY-OWNED BY:


Arising from its alliance with MorphoSys, Sosei Heptares is progressing a PAR-2-neutralizing mAb for the treatment of atopic dermatitis where reductions in pruritus (itch) and inflammation and normalization in skin barrier function are predicted. Strong literature data demonstrates that PAR-2 neutralization is also likely to be beneficial in a wide variety of disease situations including inflammatory bowel disease, pain (acute or chronic, itch, neuropathic, cancer, inflammatory, migraine), asthma.

Pre-discovery and Discovery Programs

Discovery

SARS-CoV-2 MPro

CANDIDATE: SH-879

INDICATION: Coronaviruses

MODALITY: Small molecule

WHOLLY-OWNED BY:


In April 2020, we initiated an R&D program focused on the design and development of novel drugs targeting the SARS-CoV-2 coronaviruses and to treat COVID-19. We have applied our structure-based drug design capabilities and cutting-edge technologies to precision-design new inhibitors of the SARS-CoV-2 MPro protease, which plays a crucial role in viral replication.

Potential clinical candidates have now been identified, suitable for further development. MPro inhibitor SH-879 represents an excellent opportunity for further development as an oral drug for the treatment of COVID-19:

  • Shows comparable antiviral activity to Pfizer’s oral candidate PF-07321332 against SARS-CoV-2 in cell based assays;
  • Has low in vitro clearance, superior in vivo clearance and high plasma exposure from oral dosing critically important to inhibit the virus.
  • Does not likely require co-dosing with ritonavir for PK boosting in human clinical trials, differentiating from Pfizer’s PF-07321332

+ Press Releases

+ Factsheet

Preclinical

EP4 agonist

INDICATION: Inflammatory bowel disease

MODALITY: Small molecule

WHOLLY-OWNED BY:


Sosei Heptares is developing an oral small molecule EP4 agonist for the treatment of Inflammatory bowel disease. PTGER4 has been identified as a candidate susceptibility gene for IBD and plays a critical role in maintaining barrier homeostasis. An EP4 agonist is anticipated to bring clinical benefit by improving mucosal healing. Our lead molecule is a novel gut restricted EP4 agonist that has shown robust efficacy across a range of preclinical models.