Sosei Heptares' Partner Pfizer Progresses its Oral GLP-1 Receptor Agonist PF-07081532 into Phase 2 Clinical Trials for Treating Type 2 Diabetes and Obesity

• PF-07081532 is the first clinical candidate from multi-target drug discovery collaboration to advance into Phase 2 trials
• Dosing of first subject in Phase 2 trial by Pfizer triggers payment of US$10 million to Sosei Heptares

TOKYO and CAMBRIDGE, United Kingdom, Dec. 21, 2022 (GLOBE NEWSWIRE) -- Sosei Group Corporation (“the Company”; TSE: 4565), the world leader in G protein-coupled receptor (GPCR) focused structure-based drug design (SBDD) and development, has been notified by Pfizer that the first subject in a Phase 2 clinical trial has been dosed with Pfizer’s candidate PF-07081532. Achievement of this milestone triggers a US$10 million payment to Sosei Heptares.

PF-07081532 is a once-daily, next-generation oral small molecule GLP-1 receptor agonist in development for the treatment of Type 2 diabetes and obesity. PF-07081532 was discovered by Pfizer scientists during a multi-target research collaboration in which Pfizer had access to Sosei Heptares proprietary StaR^® (stabilized receptor) technology. PF-07081532 has successfully completed Phase 1 clinical studies conducted by Pfizer.

PF-07081532 is one of three clinical candidates nominated by Pfizer during its collaboration with Sosei Heptares, all of which are now progressing in clinical trials. The other two candidates, both currently in Phase 1 trials, are:

• PF-07054894 (a CCR6 antagonist targeting Inflammatory Bowel Disease), and
• PF-07258669 (an MC4 receptor antagonist for Anorexia)

Matt Barnes, Head of UK R&D, Sosei Heptares, commented: “GLP-1 is an important and well-validated target for the treatment of Type 2 diabetes and obesity. We believe the exciting progress of PF-07081532 and other nominated candidates speaks to the power of our platform and ability to collaborate successfully with pharma partners – uniting our cutting-edge technology with Pfizer’s drug discovery, early development and clinical expertise to generate and advance drug candidates with significant therapeutic potential. We look forward to continuing the success of this partnership with Pfizer to deliver new medicines for diseases with large unmet need.”

About the Agreement with Pfizer

Sosei Heptares and Pfizer entered a multi-target drug discovery collaboration in November 2015 to research and develop potential new medicines directed at GPCR targets across multiple therapeutic areas. Many of these targets have clinical or biological validation as key points for therapeutic intervention potentially targeting a range of diseases but have proven difficult to address with conventional discovery approaches because of inherent technical challenges.

To address these challenges, Sosei Heptares and Pfizer scientists worked closely together to leverage their respective complementary expertise in enabling GPCR-focused structure-based drug design (SBDD) and development directed to the GPCR targets selected by Pfizer. Pfizer is responsible for developing and commercializing any potential therapeutic agents (small molecules or biologics) for each target and will have exclusive global rights to any potential resulting agents.

To date, Sosei Heptares has delivered multiple stabilized receptors (StaR^® proteins), X-ray structures and biophysical data on certain programs. These achievements have led to the design and development of novel small molecule candidates, three of which have now entered clinical trials. The progress under this partnership has triggered multiple significant milestone payments from Pfizer, with further payments and potential royalties possible under the agreement, provided the criteria under the agreement are satisfied.

About Sosei Heptares

We are an international biopharmaceutical group focused on the discovery and early development of new medicines originating from our proprietary GPCR-targeted StaR^® technology and structure-based drug design platform capabilities. We are advancing a broad and deep pipeline of novel medicines across multiple therapeutic areas, including neurology, immunology, gastroenterology, and inflammatory diseases.

We have established partnerships with some of the world’s leading pharmaceutical companies and multiple emerging technology companies, including AbbVie, AstraZeneca, Genentech (Roche), GSK, Kallyope, Lilly, Neurocrine Biosciences, Novartis, Pfizer, Takeda and Verily. Sosei Heptares is headquartered in Tokyo, Japan with corporate and R&D facilities in Cambridge, UK.

“Sosei Heptares” is the corporate brand and trademark of Sosei Group Corporation, which is listed on the Tokyo Stock Exchange (ticker: 4565). Sosei, Heptares, the logo and StaR^® are trademarks of Sosei Group companies.

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Forward-looking statements

This press release contains forward-looking statements, including statements about the discovery, development, and commercialization of products. Various risks may cause Sosei Group Corporation’s actual results to differ materially from those expressed or implied by the forward-looking statements, including: adverse results in clinical development programs; failure to obtain patent protection for inventions; commercial limitations imposed by patents owned or controlled by third parties; dependence upon strategic alliance partners to develop and commercialize products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from development efforts; the requirement for substantial funding to conduct research and development and to expand commercialization activities; and product initiatives by competitors. As a result of these factors, prospective investors are cautioned not to rely on any forward-looking statements. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.