Regor Therapeutics Unveils Positive Phase 2a Results for RGT-075, Stirs Hope for Obesity Treatment
On January 10, 2025, Regor Therapeutics Group, a clinical-stage private biopharmaceutical company, announced significant advancements in its Phase 2a clinical trial for RGT-075. This fast-acting drug, which is designed to be taken orally once a day, is a small molecule that fully activates glucagon-like peptide-1 receptors (GLP-1R), demonstrating a potentially groundbreaking therapeutic option for patients grappling with obesity.
Conducted across ten clinical sites throughout the United States, the Phase 2a trial involved 73 participants who were given a daily dose of 125 mg of RGT-075. After 12 weeks, the results indicated a placebo-adjusted weight reduction of 5%, a promising outcome with no plateau effect observed. Impressively, the trial reported a minimal discontinuation rate due to adverse events, mirroring that of placebo at just 4%. Only one participant required a dose adjustment during the study but was able to complete it successfully.
The CEO of Regor Therapeutics, Dr. Xiayang Qiu, expressed enthusiasm about the results, emphasizing the importance of an oral option for the millions affected by obesity and related health complications. He noted, "Patients and physicians have been clear in expressing the need for an oral formulation that provides sustainable results. Our decision to go in the small molecule direction aims to meet this urgent demand."
Often, injectable GLP-1 drugs have been hailed for their efficacy, yet many patients remain hesitant about such treatments. Consequently, an oral alternative like RGT-075 opens new doors for accessibility and convenience, potentially changing the treatment landscape for obesity.
Throughout the trial, mild-to-moderate gastrointestinal events such as nausea and vomiting were reported in 40% and 24% of the treatment group, respectively. Nonetheless, these tolerability results compare favorably with longer-term studies of other GLP-1 agents, such as Semaglutide. Besides weight loss, RGT-075 also showed meaningful impacts on important health metrics, including HbA1c and blood pressure levels.
A noteworthy feature of RGT-075 is its pharmacokinetics profile, showing a peak-to-trough ratio (PTR) of below five. This indicates the possibility of achieving consistent plasma concentration levels over 24 hours, which is essential for minimizing gastrointestinal side effects.
In tandem with announcing the Phase 2a results, Regor has initiated the COMO-1 study, a Phase 2b trial designed to evaluate multiple dose levels of RGT-075 over 36 weeks. This randomized, double-blind, placebo-controlled study seeks to involve around 240 adult participants struggling with obesity or overweight issues. The aim is to determine the efficacy in weight change from the baseline and assess the safety profile of the drug during a titration period.
Dr. Qiu continued, saying, "The compelling results from our Phase 2a trial enhance our confidence as we prepare for the larger Phase 2b study. Building upon this foundation, we aim to gather further insights critical for optimizing phase 3 dose selection and approach. With our recent $850 million deal with Roche, we're in a strong position to progress our phase 3 programs independently while seeking partnerships to refine and expedite the delivery of RGT-075 to those in need."
RGT-075 is envisioned as a breakthrough option not only for managing obesity but also for treating type 2 diabetes and its related comorbidities. Having successfully completed prior phases assessing its safety in healthy volunteers and diabetic patients, the trajectory for RGT-075 is promising. Regor Therapeutics, with its unique rCARD™ platform, is dedicated to discovering innovative treatment solutions within the realms of oncology, metabolism, and auto-immunity diseases. For more information, visit www.regor.com.
Conducted across ten clinical sites throughout the United States, the Phase 2a trial involved 73 participants who were given a daily dose of 125 mg of RGT-075. After 12 weeks, the results indicated a placebo-adjusted weight reduction of 5%, a promising outcome with no plateau effect observed. Impressively, the trial reported a minimal discontinuation rate due to adverse events, mirroring that of placebo at just 4%. Only one participant required a dose adjustment during the study but was able to complete it successfully.
The CEO of Regor Therapeutics, Dr. Xiayang Qiu, expressed enthusiasm about the results, emphasizing the importance of an oral option for the millions affected by obesity and related health complications. He noted, "Patients and physicians have been clear in expressing the need for an oral formulation that provides sustainable results. Our decision to go in the small molecule direction aims to meet this urgent demand."
Often, injectable GLP-1 drugs have been hailed for their efficacy, yet many patients remain hesitant about such treatments. Consequently, an oral alternative like RGT-075 opens new doors for accessibility and convenience, potentially changing the treatment landscape for obesity.
Throughout the trial, mild-to-moderate gastrointestinal events such as nausea and vomiting were reported in 40% and 24% of the treatment group, respectively. Nonetheless, these tolerability results compare favorably with longer-term studies of other GLP-1 agents, such as Semaglutide. Besides weight loss, RGT-075 also showed meaningful impacts on important health metrics, including HbA1c and blood pressure levels.
A noteworthy feature of RGT-075 is its pharmacokinetics profile, showing a peak-to-trough ratio (PTR) of below five. This indicates the possibility of achieving consistent plasma concentration levels over 24 hours, which is essential for minimizing gastrointestinal side effects.
In tandem with announcing the Phase 2a results, Regor has initiated the COMO-1 study, a Phase 2b trial designed to evaluate multiple dose levels of RGT-075 over 36 weeks. This randomized, double-blind, placebo-controlled study seeks to involve around 240 adult participants struggling with obesity or overweight issues. The aim is to determine the efficacy in weight change from the baseline and assess the safety profile of the drug during a titration period.
Dr. Qiu continued, saying, "The compelling results from our Phase 2a trial enhance our confidence as we prepare for the larger Phase 2b study. Building upon this foundation, we aim to gather further insights critical for optimizing phase 3 dose selection and approach. With our recent $850 million deal with Roche, we're in a strong position to progress our phase 3 programs independently while seeking partnerships to refine and expedite the delivery of RGT-075 to those in need."
RGT-075 is envisioned as a breakthrough option not only for managing obesity but also for treating type 2 diabetes and its related comorbidities. Having successfully completed prior phases assessing its safety in healthy volunteers and diabetic patients, the trajectory for RGT-075 is promising. Regor Therapeutics, with its unique rCARD™ platform, is dedicated to discovering innovative treatment solutions within the realms of oncology, metabolism, and auto-immunity diseases. For more information, visit www.regor.com.
Topics Health）
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