RGT-075

CAMBRIDGE, Mass., June 13, 2025 /PRNewswire/ -- Regor Therapeutics Group ("Regor"), a global innovator of clinical-stage biotechnology, today announced that it will present results from its Phase 2a trial of RGT-075 in adults with obesity or overweight with weight-related comorbidities at the 85th Scientific Sessions of American Diabetes Association (ADA) taking place June 20-23 in Chicago. Poster Presentation details are as follows: Presentation Title: First Report on the Small Molecule Oral GLP-1 Receptor Agonist RGT-075 in Obesity—A Randomized, Placebo-Controlled Phase 2a Proof-of-Concept Twelve-Week Study Presentation Date & Time: Sunday, June 22, 12:30 to 1:30 p.m. CDT Location: 785P 12-B About RGT-075 and the COMO-1 Phase 2b development program RGT-075 is an investigational, orally bioavailable, 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 obesity or overweight with weight-related comorbidities. Regor previously completed its Phase 1 single ascending dose (SAD) in healthy volunteers and multiple ascending dose (MAD) in patients with diabetes. RGT-075 demonstrated preliminary weight reduction in the study population and no new safety signals were observed in completed studies. RGT-075 is being evaluated in COMO-1 dose-finding trial, a Phase 2b multicenter, randomized, double-blind, placebo-controlled study to evaluate multiple doses of RGT-075 over 36 weeks in adults with obesity or overweight with weight-related comorbidities. The trial has enrolled approximately 240 participants. All participants on RGT-075 will be given RGT-075 once daily (QD) titrated up over 12 weeks. The primary endpoint is percent change in body weight from baseline to week 36. Secondary endpoints include safety and tolerability of the monthly titration scheme, as well as pharmacokinetics of RGT-075. Topline data from the Phase 2b study are expected at the end of 2025. About Regor Therapeutics Regor Therapeutics Group is a clinical-stage biotechnology company, headquartered in Cambridge, MA and with operations in Houston, San Diego, and Shanghai, which is developing innovative and clinically differentiated medicines to address large unmet needs in oncology, metabolism, and auto-immunity. Regor is powered by the highly efficient drug discovery engine rCARDTM (Regor Computer Accelerated Rational Discovery) that enables rapid prototyping and validation of candidate molecules. This rapid approach to developing small molecules against high-profile targets is the creation of the four cofounders who collectively brought decades of experience in leading US biopharma and were previously the named inventors of 4 FDA-approved medicines. The power of the rCARDTM platform and approach has been highlighted by out-licensing deals with top companies, including Roche/Genentech on next-gen CDK oncology agents RGT-419B and RGT-587 (now GDC-4198 and GDC-0587) for $850M up-front payment in late 2024, which follows an earlier endocrinology deal with a leading global biopharma. To learn more about Regor, please visit us at . Investor Relations and Communications Contact: [email protected] SOURCE Regor Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

CAMBRIDGE, MA, USA I January 10, 2025 I Regor Therapeutics Group (“Regor”), a privately-held clinical-stage global biopharmaceutical company, announced topline results from its Phase 2a clinical trial for RGT-075, a leading oral once-daily small molecule full agonist of GLP-1 receptor. In the Phase 2a trial conducted at ten clinical centers across the US, RGT-075 at 125 mg once-daily delivered statistically significant 5% placebo-adjusted weight loss with no plateau at 12 weeks (six weeks on target dose) in patients living with obesity (N = 73). There were no treatment-related severe adverse events. Discontinuation rates due to any adverse events were 4%, identical for patients receiving the active treatment and those on the placebo. Only one patient (2%) required dose reduction, and she completed the study successfully at the 60 mg once-daily dose. Regor CEO Xiayang Qiu, Ph.D., commented, “The existing GLP-1 peptide drugs have demonstrated immense value and unprecedented promise. However, we have heard loud and clear the pleas of physicians and patients for an oral version that can provide sustainable benefits and be accessible for the hundreds of millions of patients living with obesity and weight-related comorbidities.” Dr. Qiu added, “We chose to pursue the small molecule route because of its proven suitability for long-term use as once-daily oral medications, along with the inherent advantage of easier manufacturing and supply in desired quantities. We succeed when patients have better options, and we believe RGT-075 has achieved an early proof-of-concept milestone through this phase 2a study.” In the RGT-075 treatment arm, at least one event of mild-to-moderate nausea and vomiting was reported for 40% and 24% patients, respectively. Michael Grimm, M.D., Ph.D., Head of Metabolic Diseases at Regor commented, “Even with only six weeks of titration, our tolerability results are already comparable to those observed for semaglutide in longer studies.” “Beyond peptide-like weight loss with no plateau at 12 weeks, RGT-075 also showed robust and clinically meaningful efficacy in HbA1c and in Systolic and Diastolic blood pressure.” RGT-075 has previously demonstrated a promising PK-profile, with a peak-to-trough ratio (PTR) of under 5. Developers hypothesize that delivering target 24-hour plasma concentration with a relatively low PTR correlates with improved tolerability to GI-related symptoms. About the COMO-1 Phase 2b development program Today Regor also announced the initiation of the COMO-1 dose-finding trial for RGT-075. The Phase 2b multicenter, randomized, double-blind, placebo-controlled study will evaluate multiple doses up to 225 mg of RGT-075 over 36 weeks compared with placebo in adult patients with obesity or overweight with weight-related comorbidities. Approximately 240 adult participants will be enrolled and randomized to RGT-075 or placebo. All participants on RGT-075 will be given RGT-075 once daily (QD) titrated up over 12 weeks. The primary endpoint is percent change in body weight from baseline to week 36. Secondary endpoints include safety and tolerability of the monthly titration scheme, as well as pharmacokinetics of RGT-075. Topline data from the Phase 2b study are expected at the end of 2025. Dr. Qiu commented, “Building upon the strong results to date, the phase 2b study is designed to provide further insights to optimize phase 3 dose selection and titration design. With our recent $850M up-front deal with Roche in breast cancer, we have the financial means to launch RGT-075 Phase 3 programs on our own, but we are genuinely interested in partnership with expert investors and companies to accelerate its path to patients and to explore rational combination approaches, expanding the potential of this best-in-class oral small molecule GLP-1 drug for sustained management of obesity and numerous weight-related comorbidities” About RGT-075 RGT-075 is an orally bioavailable, 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 obesity or overweight with weight-related comorbidities. Regor previously completed Phase 2a studies in patients with obesity, Phase 1 single ascending dose (SAD) in healthy volunteers and multiple ascending dose (MAD) in patients with diabetes. RGT-075 was safe and well-tolerated in clinical trials completed to date, with emerging efficacies comparable to the approved peptide GLP-1 drugs. About Regor Therapeutics Regor Therapeutics Group is a clinical-stage biotechnology company, headquartered in Cambridge, MA and with operations in Houston, San Diego, and Shanghai, which is developing innovative and clinically differentiated medicines to address large unmet needs in oncology, metabolism, and auto-immunity. Regor is powered by the highly efficient drug discovery engine rCARD TM (Regor Computer Accelerated Rational Discovery) that enables rapid prototyping and validation of candidate molecules. This rapid approach to developing small molecules against high-profile targets is the creation of the four cofounders who collectively brought decades of experience in leading US biopharma and were previously the named inventors of 4 FDA-approved medicines. The power of the rCARD TM platform and approach has been validated by out-licensing deals with top companies, including Roche/Genentech on next-gen CDK oncology agents RGT-419B and RGT-587 (now GDC-4198 and GDC-0587) for $850M up-front payment in late 2024. To learn more about Regor, please visit us at www.regor.com . SOURCE: Regor Therapeutics