Sosei Heptares Notes its Partner Tempero Bio has Received FDA Clearance to Advance Clinical Development of TMP-301 for Treatment of Alcohol and Substance Use Disorders

Sosei Heptares Notes its Partner Tempero Bio has Received FDA Clearance to Advance Clinical Development of TMP-301 for Treatment of Alcohol and Substance Use Disorders

• TMP-301 (formerly HTL0014242) is a potent, selective, and orally available mGluR5 negative allosteric modulator (NAM) candidate discovered by Sosei Heptares and out-licensed to Tempero Bio
• Phase 1 study in healthy volunteers expected to begin in Q1 2023 with support from a US$5.3M grant from the US National Institute on Drug Abuse (NIDA)
• Tempero Bio was created by Aditum Bio in collaboration with Sosei Heptares in 2020 to advance the clinical development of mGluR5 NAM candidates to develop therapies targeting substance use disorders and anxiety
• Sosei Heptares holds a strategic equity stake in Tempero Bio and retains an economic interest in TMP-301 and other compounds in the mGluR5 NAM program out-licensed to Tempero Bio

Tokyo, Japan and Cambridge, UK, 5 January 2023 – Sosei Group Corporation (“the Company”; TSE: 4565), the world leader in G protein-coupled receptor (GPCR) focused structure-based drug design (SBDD) and development, notes its partner Tempero Bio has announced FDA clearance of its Investigational New Drug (IND) application for TMP-301 (formerly HTL0014242) for the treatment of alcohol and substance use disorders. Tempero Bio is planning to initiate a Phase 1 study with TMP-301 in healthy volunteers in Q1 2023 with support from a recently awarded USD$5.3M grant from the US National Institute on Drug Abuse (NIDA). The full announcement from Tempero Bio is here.

Matt Barnes, Head of UK R&D, Sosei Heptares, commented: “We would like to congratulate the team at Tempero Bio on reaching this important milestone. We look forward to further clinical development progress from Tempero Bio with TMP-301 and its mGluR5 NAM pipeline as it seeks to develop effective treatments for patients with serious substance and alcohol use disorders.”

Tempero Bio was created in 2020 by the venture firm Aditum Bio (established by industry veterans Joe Jimenez and Mark Fishman) in collaboration with Sosei Heptares to advance the clinical development of a portfolio of potent, orally available metabotropic glutamate receptor 5 (mGluR5) negative allosteric modulator (NAM) modulators, including TMP-301, discovered by Sosei Heptares to develop therapies targeting substance use disorders and anxiety.

Under the terms of the agreement, Tempero Bio acquired exclusive global rights to Sosei Heptares’ portfolio of mGluR5 NAM candidates. In return, Sosei Heptares received a strategic equity stake in Tempero Bio and is eligible to receive future success-based development and commercial milestone payments plus tiered royalties from any future product sales.

The regulatory milestone achieved as noted in this announcement does not trigger a payment from Tempero Bio to Sosei Heptares.