- GPR35 is a novel target with an established genetic association to IBD
UK regulatory approval received to commence first-in-human studies- Independent commercial analysis supports a worldwide peak sales opportunity of more than
US$3 billion for GSK4381406 with its unique target product profile
GSK4381406 was designed by Sosei Heptares using its proprietary structure-based drug design (SBDD) platform and licensed to GSK in 2020. Since then, Sosei Heptares and GSK have advanced GSK4381406 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 Sosei Heptares and GSK to gain approval from the
The Company is to regain full ownership of the GSK4381406 program following a decision by GSK to deprioritize and discontinue its development due to changes to both its immunology research strategy and immunology research leadership. The decision was not based on any scientific, preclinical or safety data related to GSK4381406. Under the terms of the 2020 agreement between the companies, Sosei Heptares has the right – for no upfront payment – to regain full ownership of the GSK4381406 program, together with all associated intellectual property licensed by Sosei Heptares to GSK, and preclinical data generated under the partnership. GSK becomes eligible for a low single digit royalty from Sosei Heptares on net sales of GSK4381406 should it become commercially available.
Sosei Heptares’ strategy is to advance novel or best-in-class products through early clinical development before seeking a partner to develop and commercialize in major markets. Following the Company’s acquisition of Idorsia’s pharmaceutical businesses in
Upon completion of the process to regain ownership of the GSK4381406 program, Sosei Heptares expects to proceed with the planned Phase 1 trial in the
“We have enjoyed a productive partnership with GSK over the past few years and understand and respect its decision as the result of a reprioritization of its immunology pipeline. For Sosei Heptares, this represents a significant opportunity, and one we have capitalized on several times over recent years, to regain and re-partner promising programs that have benefited from external collaboration and investment to validate their potential and advance them through development.
“The return of the GPR35 agonist program, with its first-in-class mechanism of action and potential to address major unmet needs in IBD worldwide, would be a welcome addition to our growing clinical pipeline. We have already commissioned an independent commercial analysis and believe GSK4381406 has global peak sales potential of more than
About the Agreement with GSK
Sosei Heptares and GSK entered into a Global Collaboration and License Agreement in
* Compound code to be changed to Sosei Heptares’ format in future.
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About Sosei Heptares
Sosei Heptares is a fully integrated biopharmaceutical company focused on bringing life-changing medicines based on world-class science to patients globally. Our vision is to become one of Japan’s global biopharmaceutical champions.
Our global business combines our world-leading GPCR-targeted StaR® technology, structure-based drug design and early development capabilities in the
We are leveraging these capabilities to generate and advance a broad and deep pipeline of novel medicines across multiple therapeutic areas, including neurology, immunology, gastroenterology and inflammatory diseases. We intend to develop these opportunities for patients in
Sosei Heptares operates from key locations in
“Sosei Heptares” is the corporate brand and trademark of
For more information, please visit https://soseiheptares.com/
LinkedIn: @soseiheptaresco | Twitter: @soseiheptaresco | YouTube: @soseiheptaresco
Enquiries:
Sosei Heptares – Media and Investor Relations
Shinichiro Nishishita, VP Investor Relations, Head of Regulatory Disclosures
+81 (0)3 5210 3399 | +44 (0)1223 949390 | IR@SoseiHeptares.com
+44 (0)203 928 6900 | SoseiHeptares@medistrava.com
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.
Source:
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