M Pharmaceutical (OTCQB:MPHMF; CSE:MQ; FWB:T3F1.F) is advancing a family of biomedical technologies to manage obesity – TriMeo and TriMtec – and eMosquito to manage diabetes.
“All three of our technologies represent a spectrum of solutions with reduced invasiveness and enhanced effectiveness than currently available approved solutions,” Dr. Martin Mintchev, president and CEO, says in an interview with BioTuesdays.com.
M Pharma’s TriMeo is a drug-free, weight loss capsule, TriMtec is a laparoscopically implantable gastric stimulation system and eMosquito is a blood glucose monitor worn like a bracelet.
TriMeo has been approved for sale in the EU as a dietary supplement. “It has been our decision to re-register it as a medical device, so that it enters doctors’ prescription books and is administered under medical supervision,” Dr. Mintchev points out.
“Our plan is to proceed with CE Mark approval for TriMeo,” he contends. “We will need to do a trial with at least 60 volunteers for safety and then a trial with 120 people to demonstrate effectiveness. We hope to start the process this year and conclude with registration in a three-year framework.”
Each TriMeo capsule is designed to expand in the stomach to the shape of a “pillow” to a size of about 30 cubic centimeters, which is large enough that it will not exit the pylorus that connects the stomach to the duodenum.
Dr. Mintchev says that by taking three capsules a day, each of which stays in the stomach for several days, “patients constantly have a gastric volume displacement of about 300-to-350 cubic centimeters. This is significant and it is achieved dynamically.”
In an earlier two-month, placebo-controlled study of 16 overweight and obese volunteers, TriMeo achieved a statistically significant reduction in all anthropometric indicators of obesity, Dr. Mintchev says. The study was reported in the journal, Current Obesity Reports, in 2012.
The study found that average body weight and average body mass each dropped 6%, with average waste measurements reduced by 5.6% and average hip measurements down 4.3%.
“Another important finding was that people in the study learned to eat less,” he adds, noting that in month two of the study, there was continued weight reduction when TriMeo capsules were not taken. “This indicates we have the potential to administer treatment in alternate months.”
Dr. Mintchev says the company will be seeking approval of TriMeo as a medical device to be prescribed by a physician rather than a dietary supplement.
Three issued patents in the U.S., Canada and European Union, and four patents pending cover TriMeo. The original patent portfolio also expands applications to other therapy and diagnostic areas, such as a drug delivery platform and colon cancer diagnosis, he adds.
M Pharma’s second technology for obesity management is the implantable TriMtec gastric stimulation system (GES), which is designed to make the stomach contract and push food content down. Eight issued patents in the U.S. and Canada cover the technology.
Dr. Mintchev also points out that the technology can be used to delay or increase gastric empty, treating obesity and gastroparesis, a condition in which the stomach can’t empty food properly.
A gastric electrical stimulation study conducted by the Chinese manufacturer of the device on eight chronic dogs found statistically significant weight loss during real stimulation sessions and gradual long-term weight gain during sham stimulation sessions.
Among other things, the study resulted in food intake dropping 23% in one month, with average food intake down 26.3% in three months.
Dr. Mintchev says the company is in the process of concluding an exclusive manufacturing deal with the Chinese maker of TriMtec. However, the Chinese plant needs ISO certification, which could take two years or more.
M Pharma currently has a patent pending on its diabetes management technology, eMosquito, for automatic and autonomous monitoring of blood glucose by diabetics.
Worn like a bracelet, the device, which draws a blood sample similar to a mosquito bite, now consists of a single-cell prototype and has been successfully tested in a human pilot study.
The company is developing eMosquito into a six-cell device that will draw a blood sample every two hours over a 12-hour period. Eventually, each cell will be incorporated into a blood glucose-monitoring device, with reports delivered wirelessly.
The most important element of the system is blood extraction, Dr. Mintchev maintains. Future studies will be required to show that eMosquito is as reliable as finger pricking to draw blood.
“The beauty of this technology is that we can also tie in an insulin infusion pump and effectively close the loop and create an artificial pancreas outside the body,” he adds.