Biophytis Provides Enrollment Update in Its Phase 2b SARA-OBS and SARA-INT
Studies of Sarconeos in Sarcopenia
Over 200 patients recruited in the SARA-OBS study with the majority of patients
enrolled from the U.S. and Belgium
60 patients ready to enter the SARA-INT trial
Paris (France), September 4, 2018, 7.30am - BIOPHYTIS (Euronext Growth Paris:
ALBPS), a biotechnology company specializing in the development of drug
candidates to fight age-related degenerative diseases, today announced that it
has enrolled over 200 of the 334 sarcopenic patients in the Phase 2b SARA-OBS
study in the 11 centers opened in the United States and in Europe, and that 60
patients have passed the 6-month observational phase and are now ready to enter
the interventional phase of the study. The interventional study, SARA-INT, has
already started in Belgium and will expand to the United States in the 11
centers already opened under SARA-OBS, as well as in the 11 new centers
dedicated to SARA-INT.
Stanislas Veillet, CEO of BIOPHYTIS, said: "The significant recruitment of
Sarcopenic patients already carried out in the United States and in Belgium in
our Phase 2b SARA-OBS clinical trial shows the rapid progress of the study that
will allow us to test the efficacy of our drug candidate Sarconeos and validate
our technology. This also marks our strong foothold in the United States, as
2/3 of the patients recruited under SARA-OBS were in the United States.
Recruitment of the majority of patients in SARA-INT is expected to be completed
by the end of the year, which will provide preliminary results in the second
half of 2019."
The double-blind, placebo-controlled Phase 2b SARA-INT study will include
approximately 334 patients, of which more than 200 have already been recruited
under SARA-OBS, which includes 11 clinical centers in Europe (Belgium, France
and Italy) and in the United States. Of these more than 200 patients, 60 of
them have already completed the observational study and are ready to enter the
interventional study. The rest of the patients will be recruited from 11 new
clinical centers, which are in the process of opening specifically for
The clinical protocol, in particular the inclusion criteria and the main
criterion, was defined following the scientific opinion of the European
Medicines Agency (EMA) and the comments of the Food & Drug Administration (FDA)
in the context of a new experimental drug application (IND). In 2017, the FDA
and the Belgian Medicines Agency (AFMPS) gave their agreements to start this
study. The agreement of the French and Italian agencies are expected to be
obtained before the end of 2018.
Dr. Roger Fielding, Professor of Medicine, Tufts University of Medicine in
Boston, is the Principal Investigator of the study and the Chairman of the
Company's Steering Committee. Dr. Marco Pahor, Professor and Founding Chair of
the Department of Aging and Geriatric Research and Director of the Institute on
Aging at the College of Medicine, University of Florida in Gainesville, is Vice
President of the Steering Committee. Additionally, as announced earlier, the
Company recently appointed Dr. Samuel Agus as Chief Medical Officer of
Biophytis, who is based in Cambridge, MA, to supervise the Company's clinical
trials, especially those conducted in the US as part of the SARA study.
1. To evaluate the safety and efficacy of two doses of BIO101 (175 mg bid and
350 mg bid) given orally for 26 weeks placebo in a population of men and women
over 65 years of age. years with a risk of motor disability.
2. Estimate the effect of treatment, improvement of physical function, and
decreased risk of motor disability after six months of treatment with placebo
in the target population.
Main evaluation criterion:
The walking speed measured during the test of 400 meters of walking, the
variation compared to the baseline at the 6th month will be compared between
the groups treated (each dose compared to placebo).
Main secondary endpoints:
Variation from baseline of standard Patient-Reported Outcome (PRO): PF-10 score
of SF36; chair lift test (SPPB intermediate score);
Other secondary evaluation criteria:
Change in baseline of appendix body mass (ALM), body composition measured by
DEXA, muscle strength (handle / knee extension); climb test of the stairs;
SPPB; 6 minutes walk;
334 individuals (male or female over 65 years) reporting a loss of physical
function within the last 6-12 months and considered at risk of motor disability
will be included in the SARA-INT random interventional clinical trial (106).
patients per treatment group) and will take treatment over 26 weeks.
Main inclusion criteria:
1. Male or female, over the age of 65, living in the vicinity, reporting a loss
of physical function in the past 6 to 12 months
2. SPPB score ≤ 8
3. ALM / BMI <0.789 in men and 0.512 in women, or ALM <19.75 kg in men and
<15.02 kg in women, measured by DEXA scan.
Sarconeos is a first-in-class drug candidate based on the activation of the MAS
receptor (major player of the renin-angiotensin system) restoring muscular
anabolism, inhibiting myostatin, and that had demonstrated meaningful activity
in animal models of muscular dystrophies. Sarconeos is developed in the
treatment of sarcopenia, an age-related degeneration of skeletal muscle,
leading to loss of mobility in elderly people. This condition, for which no
medical treatment currently exists, was first described in 1993 and has entered
the International Classification of Diseases (M62.84) in 2016. It affects more
than 50 million people worldwide.
Biophytis SA (www.biophytis.com), founded in 2006, develops drug candidates
targeting diseases of aging. Using its technology and know-how, Biophytis has
begun clinical development of innovative therapeutics to restore the muscular
and visual functions in diseases with significant unmet medical needs.
Specifically, the company is advancing two lead products into mid-stage
clinical testing this year: Sarconeos (BIO101) to treat sarcopenic obesity and
Macuneos (BIO201) to treat dry age-related macular degeneration (AMD).
The business model of BIOPHYTIS is to ensure the conduct of the project until
clinical activity in the patient is proven, then to license the technologies in
order to continue the development in partnership with a pharmaceutical
Based on the Sorbonne Université campus, Biophytis collaborates with expert
scientists from several Sorbonne Université institutes such as the Paris Seine
Biology Institute, the Institute of Myology, and the Vision Institute.
BIOPHYTIS is listed on the Euronext Growth market of Euronext Paris
(ALBPS; ISIN: FR0012816825).
For more information: http://www.biophytis.com
Follow us on Twitter @biophytis
BIOPHYTIS is eligible for the SMEs scheme
This press release contains certain forward-looking statements. Although the
Company believes its expectations are based on reasonable assumptions, these
forward-looking statements are subject to numerous risks and uncertainties,
which could cause actual results to differ materially from those anticipated.
For a discussion of risks and uncertainties which could cause the Company's
actual results, financial condition, performance or achievements to differ from
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looking statements involving risks and uncertainties. The Company's actual
results could differ substantially from those anticipated in these statements
owing to various risk factors which are described in the Company's prospectus.
This press release has been prepared in both French and English. In the event
of any differences between the two texts, the French language version shall