CAMBRIDGE, Mass., March 8, 2024 /PRNewswire/ -- Regor Therapeutics Group ("Regor"), a clinical-stage global biopharmaceutical company powered by a cutting-edge drug discovery engine and differentiated clinical development pipeline, today announced that its Phase 2 trial of the highly selective oral GLP-1 agonist RGT-075 is initiated in adults with obesity or overweight with weight-related comorbidities and has First Patient First Visit (FPFV) on Mar 08, 2024. The topline results for this Phase 2 trial are expected to be announced in the second half of 2024. "The initiation of the Phase 2 trial marks an important milestone in the development of RGT-075 as we believe it could represent a convenient and potentially meaningful alternative to the currently available weight loss treatments," said Michael Grimm, M.D., Ph.D., Head of Metabolic Diseases at Regor. "RGT-075 is designed to be administered orally once daily as a monotherapy or as part of a potential oral combination treatment for obesity. Phase 1 clinical data showed promising exploratory body weight trends despite short treatment duration," added Dr. Grimm.

About the RGT-075 development program

The Phase 2 multicenter, randomized, double-blind, placebo-controlled study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of once-daily oral RGT-075 compared with placebo in adult patients with obesity or overweight with weight-related comorbidities. Approximately 60 adult participants with a BMI ≥ 27 kg/m² and ≤ 45 kg/m² will be enrolled and randomized to RGT-075 or placebo. The treatment will last 12 weeks; all participants on RGT001-075 will be given RGT-075 once daily (QD) titrated up over 6 weeks, then being maintained with the target dose for 6 weeks. Topline data from the Phase 2 study are expected to be announced in the second half of 2024.

About RGT-075

RGT-075 is an oral-available, once-daily, small molecule GLP-1R full agonist discovered and developed by Regor for the treatment of metabolic diseases, such as type-2 diabetes mellitus and overweight/obesity. Regor completed its Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) studies. RGT-075 was safe and clinically well-tolerated in clinical trials completed to date.

About Regor Therapeutics Group

Regor Therapeutics Group ("Regor") is founded in 2018 by a team of scientists with a proven track record in drug discovery and executive leadership covering full cycle of drug discovery and development. By leveraging its industry-leading core strength in rCARD™ (Computer Accelerated Rational Discovery), Regor has completed 8 PCCs inhouse, with 5 INDs filed, validating Regor's highly efficient ecosystem for accelerated discovery of innovative therapeutic agents.

Regor's in-house pipeline encompasses leading assets in metabolism, oncology and auto-immunity, with two leading assets: 1) RGT-075, an orally bioavailable small molecule GLP1R full agonist with best-in-class potential for obesity & beyond; and 2) RGT-419B, a unique CDK4+ inhibitor showing outstanding single agent responses in refractory ER+/HER2- breast cancer patients.

With a strong focus on excellence in pharmaceutical research and global competitiveness, Regor aspires to build a world-class innovation engine that promotes a winning culture of scientific excellence, strong teamwork driven by results and delivery with shared accountability and successes.

IR Contact:Investor Relations and Communicationsir@regor.com