M PHARMACEUTICAL INC. ANNOUNCES FINDINGS FROM PREVIOUS LEAD PILOT STUDY SHOWING C-103, A PROPRIETARY REFORMULATION OF ORLISTAT, ELIMINATES 98% OF ORLISTAT’S GASTROINTESTINAL ADVERSE EFFECTS
M Pharmaceutical Inc. (MQ.C) has provided existing data from the historical research and pilot study as they relate to the recently acquired Chelatexx technology, referred to as the company’s C-103 project. In this study, C-103 was over 98% effective in eliminating the GI adverse events associated with Orlistat.
In total, M Pharma has reviewed three pilot studies related to company’s recently acquired patented Chelatexx technology, each of which provides strong validation for the development of the C-103 reformulation of Orlistat.
C-103 is a novel formulation of Orlistat, patented until 2030 in the United States. Orlistat is FDA-approved for weight management and sold by Roche as Xenicaltrademark (prescription) and by GlaxoSmithKline as allitrademark (over-the-counter). Orlistat is the best-selling weight loss medication of all time with peak sales of over $900 million in 2007, but use is limited by socially unacceptable bowel-related side effects (fecal incontinence, oily spotting, and flatus with discharge), which lead to 90% of patients stopping treatment in the first month of use. C-103 is a patented, proprietary combination of Orlistat, simethicone and activated charcoal, which is designed to maintain the efficacy of Orlistat while minimizing its bowel-related side effects. The drugs are not systemically absorbed, and all are approved by the FDA for OTC usage and have strong safety profiles.
The lead pilot study, “Chelatexx Test Agent for Decreased GI Adverse Events compared to Orlistat API” (Active Pharmaceutical Ingredient), was conducted by Ronald J. Thompson MD (Principal Investigator) and James M. Thompson (Secondary Investigator) in Cincinnati, Ohio. Highlights from the Study include:
FDA research has documented that over 90% of Orlistat users have experienced adverse events like fecal incontinence, oily spotting and flatus with discharge That 90% rate was significantly reduced to less than 2% when accompanied with our Chelatexx Technology over the course of the Study. In terms of overall efficacy, the test agent in this pilot study was over 98% effective in eliminating the GI adverse events associated with Orlistat.
The primary study objective was to demonstrate the effectiveness of C-103 in reducing bowel-related side effects compared to Orlistat taken alone. The methodology was a single center, open label, pilot proof-of-concept study conducted over four weeks with ten subjects. The test agent was taken three times daily with meals over the study duration. All dosage components of the test agent were used in accordance with their approved labeling and indications for use.
In terms of overall efficacy, C-103 was over 98% effective in eliminating the GI adverse events compared to Orlistat alone. In terms of safety overall, there are few serious safety concerns associated with Orlistat therapy, and the majority of adverse events were gastrointestinal in nature and non-serious.
“We have known for several years now that the Chelatexx technology has the potential to significantly reduce the adverse events commonly experienced by consumers of Orlistat,” said Mr. Gary Thompson, President of M Pharmaceutical USA, Inc.
Mr. Thompson added: “The evidence is there in the summary data of all three studies. FDA research has documented that over 90% of Orlistat users have experienced adverse events like fecal incontinence, oily spotting and flatus with discharge. That 90% rate was significantly reduced to less than 2% when accompanied with our Chelatexx technology. Our objective is to formulate these technologies, Orlistat & Chelatexx, into one Sequential Release Duel Compartment Capsule that maintains the efficacy of Orlistat, but without the messy adverse events.”
“Building on the M Pharma acquisition of the Chelatexx drug technology and the establishment of M Pharmaceutical USA Inc., our leadership team and board of directors continue to focus our energies toward delivering weight loss solutions that people can use safely and effectively. We are encouraged by these findings and aim to make this drug technology available to the growing global market of almost 2 billion adults who can benefit from weight loss solutions like C-103,” noted M Pharma President & CEO, Mr. Brian Keane.