The safety, tolerability and pharmacokinetic profile of HTL9936 were assessed in a recently completed Phase 1 study. The data provide strong evidence of a therapeutic window for the selective M1 agonist mechanism in general, and for progression of HTL9936 and similar molecules as medicines to treat cognitive disorders. HTL9936 exhibited good brain penetration and M1 selectivity with no adverse events typically attributed to the stimulation of M2 and M3 receptors. HTL9936 also exhibited robust and statistically significant changes in brain electrical activity measured using multiple electroencephalography (EEG) biomarkers relevant to cognition. These pro-cognitive effects were seen at low doses and low blood concentrations that were safe and well tolerated.
Malcolm Weir, Chief Executive Officer of Heptares and Chief R&D Officer at Sosei, said: “We are delighted that the quality of our muscarinic agonist candidates, discovered and developed wholly in-house, and our translational capabilities have been recognized by Allergan, a global leader in the development and commercialization of treatments for CNS diseases. We have a highly committed and experienced partner in Allergan and look forward to working together towards the development of multiple new breakthrough medicines over the coming years.”
Shinichi Tamura, Chairman and CEO of Sosei Group Corporation, added: “This new agreement with Allergan marks an important milestone in our journey to become a global biopharmaceutical company. This agreement further endorses our strategic decision to acquire Heptares in February last year, placing its GPCR-directed drug discovery and development capabilities at the heart of our business.”
This transaction is subject to customary clearances under the Hart-Scott-Rodino Antitrust Improvements Act.
Sosei was advised by Moelis & Company.