Rhythm Initiates Phase IIb Clinical Trial of Relamorelin for Diabetic Gastroparesis
Rhythm, a biopharmaceutical company, and Actavis have announced the initiation of a Phase IIb clinical trial assessing the efficacy and safety of relamorelin (RM-131), Rhythm's ghrelin agonist, for the treatment of gastroparesis in patients with type 1 and type 2 diabetes. Ghrelin is a peptide hormone produced in the stomach that stimulates gastrointestinal (GI) motility. Actavis has an exclusive option to acquire Rhythm's wholly owned subsidiary, Rhythm Pharmaceuticals, Inc., upon the completion of the Phase IIb study.
"This is the second of two studies assessing the efficacy and safety of relamorelin for the treatment of diabetic gastroparesis," said Fred Fiedorek, Chief Medical Officer of Rhythm. "This Phase IIb study is designed to expand our understanding of RM-131's profile for treating diabetic patients with both moderate and severe gastroparesis, prior to the initiation of Phase III registration studies."
The Phase IIb trial is designed to evaluate the effect of relamorelin on signs and symptoms of gastroparesis, GI motility, and safety in patients with diabetic gastroparesis. The randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of dosing regimens ranging from 10 to 100 mcg administered twice daily over 3 months. The trial is expected to enroll approximately 400 patients with diabetic gastroparesis at clinical sites in the US and Europe.
Rhythm previously completed two successful Phase II clinical trials with relamorelin:
• In a Phase II trial for diabetic gastroparesis, patients treated with relamorelin 10 mcg twice daily demonstrated statistically significant improvements in gastric emptying and vomiting symptoms, and in a pre-specified subgroup also showed statistically significant improvements in the other symptoms of gastroparesis.
• In a separate Phase IIa study for chronic constipation, patients treated with relamorelin 100 mcg once daily for 2 weeks demonstrated statistically significant improvements in spontaneous bowel movements and in lower GI transit. Relamorelin demonstrated a potent prokinetic effect on GI transit in both studies, as well as in Phase I studies, and was generally well tolerated.
"The need for better treatments for diabetic gastroparesis is pressing," said Keith Gottesdiener, CEO of Rhythm. "This is a debilitating condition that affects several million people in the U.S., with only one drug approved by the FDA in the past 30 years. Thus far, relamorelin has been shown to directly improve impaired gastric function in our clinical trials, and we are excited about its potential to significantly improve the health of people suffering from this disorder."
"The clinical results with relamorelin in the initial Phase II trial in diabetic gastroparesis were precedent-setting," said David Nicholson, Executive Vice President of Global Brands Research and Development for Actavis. "Both Rhythm and Actavis are looking forward to the results from this important trial, and to the positive impact this drug may have on the lives of people with GI functional disorders."
Related News
-
News BioNTech to begin mRNA vaccine manufacturing in Rwanda by 2025
German biotechnology company BioNTech has stated their intentions to begin production at their mRNA vaccine factory in Rwanda by 2025, which will mark the first foreign mRNA vaccine manufacturing site on the continent of Africa. -
News Identifying Alzheimer’s Disease biomarker proteins with whole blood tests
A University of Manchester spin-out pharmaceutical company, PharmaKure, has reported successful study results for the quantification of Alzheimer’s Disease biomarker proteins with a whole blood test. -
News Bill & Melinda Gates Foundation to boost mRNA vaccine initiatives in Africa with USD $40m
To address vaccine inequality and accessibility issues, the Bill & Melinda Gates Foundation aims to deliver USD $40m to various biotech companies and vaccine manufacturers in support of mRNA vaccine development. -
News CPHI Podcast Series: Exploring neurological frontiers in Alzheimer's and beyond
The next episode of the CPHI Podcast Series delves into the science and background behind some recent developments in the field of Alzheimer's disease and neurological disorders. -
News Is patient centricity the future of pharmaceutical manufacturing?
In this interview with Sandra Sánchez y Oldenhage, President of PharmAdvice, she speaks to the importance of considering patients in the manufacturing stages of the pharmaceutical supply chain, and how it can redefine healthcare. -
News CPHI Podcast Series: How to leverage AI for Drug Discovery
Artificial intelligence is the topic of debate in the latest episode from the CPHI Podcast Series, where Digital Editor Lucy Chard speaks with Bill Whitford of DPS Group about the integration of AI in healthcare. -
News Pfizer forges ahead with blood cancer therapy after approval from FDA
Pfizer gains accelerated approval from the US FDA for their new bispecific antibody therapy for multiple myeloma, set to address an unmet need for patients. -
News Alzheimer's drug donanemab deemed effective in landmark clinical trial
Results from the TRAILBLAZER-ALZ 2 Randomised Clinical Trial into the use of donanemab to treat early symptoms of Alzheimer’s disease have been analysed.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance