VANCOUVER, B.C., CANADA (September 15th, 2016) - M Pharmaceutical Inc. (CSE: MQ, OTCQB: MPHMF, FWB: T3F2), (the "Company" or “M Pharma”), today announced findings from the third of three proprietary pilot studies previously conducted. The three studies relate directly to the recently acquired Chelatexx technology, referred to as the Company’s C-103 project. The third study, conducted in India, found that C-103 was over 97% effective in eliminating the GI adverse events associated with orlistat.
This finding is consistent with the first and second of the three pilot study findings announced on August 11th and August 25th 2016 respectively, which both found C-103 was over 98% effective in eliminating the GI adverse events associated with orlistat.
M Pharma has completed its review of the three previously conducted pilot studies related to the Company’s recently acquired patented Chelatexx technology. The results of the studies provide 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 Xenical® (prescription) and by GlaxoSmithKline as alli® (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). 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.
To remain consistent, the third pilot study was titled, “Open label, single center pilot proof of concept study to assess a combination of orlistat, simethicone and activated charcoal in ameliorating the gastrointestinal adverse effects compared to orlistat taken alone as a single medication.” The primary study objective was to demonstrate the effectiveness of a patented, proprietarycombination of orlistat, simethicone and activated charcoal to ameliorate the gastrointestinal adverse effects compared to orlistat API (active pharmaceutical ingredient) taken alone. Participants were not asked to change their diets for the study.
Highlights from the study include:
- The study was conducted at a single center in India over one week with forty subjects;
- The test agent – C103, was taken three times daily with each meal, breakfast, lunch and dinner 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 97% effective in eliminating (preventing) the gastrointestinal adverse events compared to orlistat alone. The rate of adverse events was 2.6% (22 adverse events/840 meals).
“FDA research has documented that over 90% of orlistat users have experienced adverse events termed underwear issues. According to FDA data, approximately 90% of orlistat users discontinue the product within a month due to those underwear issues,” said Mr. Gary Thompson, President of M Pharmaceutical USA, Inc.
“We believe it is significant that patients taking orlistat, either OTC or prescription based, are advised to ingest less fat per meal in order to reduce the occurrence of the GI adverse events. In these studies, patients were NOT asked to change their eating habits or lower the amount of dietary fat ingested per meal, which is an indicator as to the effectiveness and practicality of the C-103 reformulation of orlistat,” added Mr. Thompson.
“M Pharma’s review and assessment of these three studies fully supports our business objective to advance toward the commercialization of C-103, with the goal of helping millions of people to reach and maintain a healthy weight.” added M Pharma President and CEO, Mr. Brian Keane.
About M Pharmaceutical Inc.
Formed in early 2015, M Pharmaceutical Inc. is a clinical-stage company developing innovative technologies for obesity and weight management. In addition to its recent acquisition of C-103, a reformulation of Orlistat from Chelatexx, LLC, the Company will focus on the development of its Trimeo capsules, temporary controllable pseudobezoars for non-invasive gastric volume reduction for the treatment of obesity, for which it has exclusive rights.
M Pharmaceutical Inc. trades on the Canadian Securities Exchange (CSE) under the ticker symbol “MQ” as well as on the OTCQB as “MPHMF” and FWB (Frankfurt Stock Exchange) as “T3F2.”
Notice regarding Forward Looking Statements: This news release contains forward-looking statements. The use of any of the words "anticipate", "continue", "estimate", "expect", "may", "will", "project", "should", "believe" and similar expressions are intended to identify forward-looking statements. Although the Company believes that the expectations and assumptions on which the forward-looking statements are based are reasonable, undue reliance should not be placed on the forward-looking statements because the Company can give no assurance that they will prove to be correct. This news release includes forward-looking statements with respect to the commercialization of the rights to the company’s biomedical & drug technologies. Since forward-looking statements address future events and conditions, by their very nature they involve inherent risks and uncertainties. These statements speak only as of the date of this news release. Actual results could differ materially from those currently anticipated due to a number of factors and risks including various risk factors discussed in the Company's disclosure documents which can be found under the Company's profile on www.sedar.com and the Company’s filings to the CSE at www.cnsx.ca. Such risk factors may cause the inability of the Company to successfully commercialize any of its biomedical technologies.
Notice regarding investigational devices: C-103 and Trimeo are investigational drugs or devices and are not currently available outside of approved clinical trials. Claims regarding the safety and efficacy of these devices have not been evaluated by Health Canada, the U.S. Food and Drug Administration, or any other international regulatory body.