Date: 2017-05-11
Type of
information: Clinical trial authorisation
phase: 2
Announcement: clinical trial authorization
Company: Biophytis (France)
Product: Sarconeos (formerly SARCOB BIO101)
Action
mechanism: Sarconeos is the first representative of a new class of drug candidates, based on the activation of the MAS receptor (major player of the renin-angiotensin system) stimulating anabolism in the muscle, inhibitor of myostatin and favoring muscle mass development in animal models of muscular dystrophies.
Disease: sarcopenia
Therapeutic
area: Muscle disorders
Country: Belgium, France, Italy, USA
Trial
details:
- SARA-OBS is a clinical observational study aimed at recruiting and characterizing a patients’ population diagnosed with sarcopenia, that could be ultimately enrolled in the phase 2b study, SARA-INT :
- - 300 sarcopenic patients recruited according to the criteria defined by the Foundation for the National Institutes of Health ,
- - 8 clinical centres in Europe and in the United States, will be involved, including Toulouse, Liege, Rome, Gainesville and Boston,
- Patients’ mobility and muscular quality will be assessed for a period of 6 months, based on the following criteria: 6-minute walk test, muscle strength, muscular mass, plasma biomarkers of activity.
- Participants aged ? 65 years complaining of poor physical function will be selected to perform SPPB (Short Physical Performance Battery)tests. Those with SPPB scores ? 8/12 will be selected to perform body composition analysis with DXA Scan. Participants with ALM/BMI < 0.789 in men and 0.512 in women will be included. The investigational phase will comprise two main visits: the inclusion visit and the 6-month visit. (NCT03021798)
Latest
news:
- • On May 11, 2017, Biophytis has announced that it has received the approval from the US regulatory authorities for the recruitment of sarcopenia patients in the observational study SARA-OBS on Sarconeos. It has therefore been able
to open the two clinical centers and start the recruitment of sarcopenia patients in the United States. These patients, if they give their consent, could participate in the clinical trial of phase 2b SARA-INT, on Sarconeos. The first two clinical centers have therefore been opened, in Boston at the Jean Mayer Human Nutrition Research Center on Aging, Tufts University with head investigator Professor Roger
Fielding, and in Gainesville at the Institute of Aging, University of Florida, with investigator Professor Marco Pahor. The recruitment of the 300 patients in the 8 clinical centers opened in Europe (France, Belgium and Italy)
and the United States has now begun.
- • On March 27, 2017, Biophytis announced that the first clinical centers leading the observational study SARA-OBS have opened in Europe and started the recruitment of patients. These patients, diagnosed with sarcopenia, could later be treated with drug candidate Sarconeos in the phase 2b clinical trial SARA-INT. The first clinical centers have opened and started the screening of patients with sarcopenia in Belgium, (Liège, Prof. Bruyère, Liège University), in France (Toulouse, Profs. Vellas & Rolland, Gérontopole). It will
soon start in Italy (Roma, Profs. Donini & Gnessi, La Sapienza University). Two clinical centers in the USA (Boston, Prof. Fielding, Tufts University School of Medecine ; Gainesville,
Prof. Pahor, Institute on Aging, College of Medecine, University of Florida) should open and start recruitment in the coming weeks once final regulatory approval is received, being acknowledged that the clinical design of SARA-OBS study has already been approved by the American regulatory authority.
- • On November 22, 2016, Biophytis announced it has
received regulatory authorizationsin France and Belgium to conduct the SARA-OBS study in sarcopenia patients.
- • On September 13, 2016, Biophytis announced it has finalized the design, selected the main partners (clinical centres and CRO) and filed in France, for regulatory authorization for the SARA-OBS study in sarcopenia patients.
This clinical observational study is aimed at recruiting and characterizing a patients’ population diagnosed with sarcopenia, that could be ultimately enrolled in the phase 2b study, SARA-INT. The results of the study will complete the clinical and regulatory file for Sarconeos, required
for authorization to initiate the Phase 2b SARA-INT clinical study, in Europe and the United States, and by specifying patients’ inclusion criteria.
- An international steering committee has been constituted to oversee the SARA-OBS study. It is composed of:
- - Pr Roger Fielding, PhD, director of the Nutrition, Exercise Physiology and Sarcopenia Laboratory (NEPS) at Tufts University in Boston, lecturer at the Harvard Medical School
and member of the scientific committee of Biophytis,
- - Pr Yves Rolland, gerontologist, Professor at Toulouse’s university hospital, and practitioner at the Gerontopôle,
- - Pr Marco Pahore, Director of University Florida Institute on Aging, Professor and Founding Chair, Department of Aging and Geriatric Research,
- - Pr Olivier Bruyère, geriatrician and epidemiologist at Liège University.
- A contract was signed with ICON in order to finalize the design of the SARA-OBS study, the qualification of the 8 clinical centres selected, the granting of regulatory approvals in the four countries where the study will take place (France, Belgium, Italy and the United States), the monitoring of around 300 patients recruited in Europe and in the United States and to collect and analyze observational data.
- France is the first country where regulatory approval has been submitted for SARA-OBS. The agreement should be reached in the coming weeks. The authorization submissions in the other targeted countries will be submitted during the second half of 2016.
Is
general: Yes
