Business
Gain Therapeutics Reports Full Year 2022 Financial Results and Business Update
Company expects completion of IND-enabling studies of GT-02287 in H1 2023Submission of dossier to start Phase 1 clinical trial of GT-02287 in GBA1 Parkinson’s
About this update from Gain Therapeutics, Inc.
[{"type":"text","content":"Company expects completion of IND-enabling studies of GT-02287 in H1 2023Submission of dossier to start Phase 1 clinical trial of GT-02287 in GBA1 Parkinson’s Disease expected by mid-year 2023$22.1 million in cash and cash equivalents and marketable securities as of December 31, 2022 €1.2 million non-dilutive grant awarded to Company-led consortium to advance research program in Alpha-1 Antitrypsin Deficiency BETHESDA, Md., March 23, 2023 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain”, or the “Company”), a biotechnology company leading the discovery and development of allosteric small molecule therapies, today announced financial results for the full year ended December 31, 2022, and highlighted recent corporate progress. “We have made significant progress across our pipeline this past year and have amassed additional and significant data supporting the disease modifying potential of our allosteric GCase regulators in Parkinson’s and Gaucher disease models,” said Matthias Alder, Chief Executive Officer. “We look forward to commencing the clinical program for GT-02287 with the submission of the dossier for the Phase 1 clinical trial by mid-2023. We are also pleased with the grant funding supporting the research program in Alpha-1 Antitrypsin Deficiency, which validates the versatility of our SEE-Tx platform and the new approach to address AAT deficiency-related metabolic diseases with allosteric small molecule regulators.” Business Updates and Recent Developments GT-02287 in GBA1 Parkinson’s disease (PD) continues to advance towards the initiation of a Phase 1 clinical trial. Gain anticipates completing IND-enabling GLP toxicology studies in the first half of 2023 and commencing the clinical program with the submission of the dossier for the Phase 1 clinical trial of GT-02287 by mid-2023. The Phase 1 clinical trial will be conducted in Australia and will evaluate administration of both single and multiple ascending dose levels of GT-02287 in healthy volunteers to assess safety and pharmacokinetics, with the goal of identifying an optimal dose level for Phase 2 development. Presented preclinical data for GT-02329 at the 19th Annual WORLDSymposium™ in February 2023. In February, Gain presented new preclinical data in a poster presentation titled: “GT-02329, a Structurally Targeted Allosteric Regulator of GCase, ...