Approval of us regulatory authorities
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Opening of the clinical centers of Boston and Gainesville
Paris, may 11, 2017, 8: 00 AM BIOPHYTIS (Alternext Paris : ALBPS), a biotechnology company specializing in the development of drug candidates to treat diseases of aging, announced enrollment of the first patient in the framework of the observational study SARA-OBS. The company has received the approval of us regulatory authorities for the recruitment of patients sarcopéniques and was able to open the two clinical centres and start the recruitment of patients sarcopéniques in the United States. These patients, if they give their consent, may then be recruited to the clinical trial phase 2b SARA-INT Sarconeos.
Stanislas Veillet, ceo of Biophytis, said : “We are pleased to announce the recruitment of the first patient in the clinical study SARA-OBS in the United States. The clinical centers, the american of Boston and Gainesville are now open and welcome patients. These are specialized in the care of patients sarcopéniques, clinician of international renown, and are an ideal complement to the clinical network european. It is an important marker of the achievement of our development strategy in the United States, our primary market, which had been announced in the past year. We focus now on the preparation of phase interventional, SARA-INT, which will take over from this observational study. “.
Biophytis obtained permission from the us regulatory authorities to conduct the clinical study SARA-OBS in sarcopenia. The first two clinical centers have been opened in the United States and can accommodate the first patients : in Boston at the Jean Mayer Human Nutrition Research Center on Aging, Tufts University, with principal investigator Professor Roger Fielding, and in Gainesville at the Institute of Aging, University of Florida, with investigator Professor Marco Pahor.
The recruitment of 300 patients in 8 clinical centers is open in Europe (France, Belgium, Italy) and the United States. Patients sarcopéniques will be followed for 6 months before being included, after obtaining their consent, in the interventional study phase 2b SARA-INT.
The opening of centers in the United States is the culmination of the development strategy initiated a year ago. It has been to double the projected size of the clinical study recruiting patients in the u.s. territory (the most important area for Biophytis in terms of number of patients), to open a subsidiary in Boston, to hire clinicians, in particular, Roger A Fielding, which integrated the scientific committee of Biophytis and is the principal investigator of the study, SARA-OBS/SARA-INT.
You can learn more about the clinical program SARA and Sarcopenia, by viewing the video presentation via the following link : http://www.biophytis.com/actualites/SARA-ICFSR-2017/
About SARA-OBS : SARA-OBS is a clinical study a prospective, observational 6-month, performed on more than 300 patients with sarcopenia recruited from 8 clinical centers in Europe and the United States. The mobility and the quality muscle of the patients will be assessed on the basis of the following criteria : test of 6-minute walk, the mobility test (PPBS), muscle strength (grip test), muscle mass and plasma markers of muscle anabolism. The data of SARA-OBS will provide a better characterization of the target population for the treatment Sarconeos. The patients in the study SARA-OBS will be included at the end of 6 months in the study of phase 2b SARA-INT, after obtaining their consent. About SARCONEOS : Sarconeos is the first representative of a new class of drug candidate, receptor activator MAS (a major player in the Renin Angiotensin system), stimulating muscle anabolism, inhibiting myostatin, and promoting the development of muscle mass in animal models of muscular dystrophies. Sarconeos is developed in the treatment of Sarcopenia, muscular dystrophy, age-related characterized by a loss of mass and muscular strength, leading to a loss of mobility in seniors. This new pathological condition, without drug treatment, described for the first time in 1993 and which has just been listed in the catalogue of the diseases of WHO (M62.84), affects more than 50 million patients in the world.
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About BIOPHYTIS :
BIOPHYTIS is a company of biotechnology, established in 2006, specialized in diseases related to ageing. It develops innovative therapeutic solutions on diseases without treatment, in order to restore muscle function and visual. As well BIOPHYTIS focuses its efforts in research and development in the fight against macular degeneration related to age (AMD) and the muscular dystrophy age-related (sarcopenia). On these two pathologies is particularly catastrophic, the company has proprietary products entering phase 2b : Sarconeos and Macuneos. Installed on the campus of the University Pierre and Marie Curie (UPMC, 5 place Jussieu, 75005 Paris), BIOPHYTIS relies on collaborations with prominent research with the UPMC, in particular the Institute of Myology and the Vision Institute.
BIOPHYTIS is a company listed on the Alternext market of Euronext Paris
(ALBPS ; ISIN : FR0012816825).
For more information : http://www.biophytis.com
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