BIOPHYTIS (EPA:ALBPS) - Biophytis appoints a new Chief Medical Officer based in the USA

Transparency directive : regulatory news

02/07/2018 07:30

Press release

    Biophytis appoints a new Chief Medical Officer based in the USA

Paris (France), July 2nd, 2018, 7.30 am - BIOPHYTIS (Euronext Growth Paris:
ALBPS), a biotechnology company specializing in the development of drug
candidates to fight age-related degenerative diseases, today announces the
appointment of Doctor Samuel Agus as Chief Medical Officer in replacement of
Susanna Del Signore. He will be a member of the Biophytis management team.

Doctor in Medicine (The Hebrew University of Jerusalem) and holder of two PhD
in neurology and biostatistics from the Tel Aviv university, Samuel Agus has
over 15 years of experience in the pharmaceutical industry. He has held leading
positions and has a proven track record in clinical development within biotech
and leading pharmaceutical companies such as Teva Pharmaceuticals Industries,
Solvay Pharmaceuticals then Abbott Laboratories, Shire Pharmaceuticals and
Lundbeck. Since April 2017 he has been Vice President of Hansa Medical AB. An
American-Israeli citizen, Samuel Agus specializes in the field of neurology and
disorders related to neurodegeneration. He is also a specialist in rare
diseases such as Duchenne Myopathy, for which Biophytis is preparing a clinical
development plan entitled MYODA and based on the drug candidate Sarconeos.

Stanislas Veillet, CEO of BIOPHYTIS comments: "We are delighted to welcome
Samuel Agus within our team. His strong experience in the clinical development
of drug candidates will enable us to achieve our goals. His mandate will be to
strengthen our clinical teams in the United States, where we are already
settled and where our clinical trials are currently in progress, more
specifically for Sarcopenia."

Samuel Agus replaces Susanna Del Signore who has held the position so far and
decided to focus on the development of Blue Companion, an e-health company she
founded.

Samuel Agus will be based in Cambridge, Massachussetts (USA) where the company
wants to develop its clinical teams in order to support the development and
monitor its clinical trials in the United States. The SARA study program for
Sarconeos in Sarcopenia is underway in the US: more than 6 centers have already
opened for SARA- OBS and SARA-INT studies. In addition, Biophytis plans to
extend the MACA study program for Macuneos in Age- related Macular Degeneration
(MAD) and the MYODA study program for Sarconeos in Duchenne Muscular Dystrophy
(DMD). Finally, this strengthened presence will grant support to the regulatory
development of products in the United States and prepare market access in this
country.

About SARA:
The SARA program is a multicentric clinical program conducted in 4 countries
(USA, France, Belgium, Italy) to assess the effective therapeutic dose of
Sarconeos in a Phase 2b clinical study in 334 sarcopenic patients. The program
began in 2016, by conducting a safety and pharmacokinetic study on 30 healthy
elderly subjects: SARA- PK. The program includes an observational study:
SARA-OBS, which began in 2017, for 6 months, conducted on more than 300
sarcopenic patients, in 11 clinical centers. SARA-OBS data will provide a
better characterization of the Sarconeos treatment target population. After
obtaining consent, patients who participated in the SARA- OBS study may be
included in the SARA-INT Phase 2b study. The objective of SARA-INT is to
evaluate the safety and efficacy of two doses of Sarconeos (175 mg bid and 350
mg bid) administered orally for 26 weeks against placebo in a population of men
and women over the age of 65 with a risk of motor disability; and to assess the
efficacy of the treatment, namely the improvement of the physical function and
the reduction of the risk of motor incapacity.

About MACA:
The MACA program is a multicentric clinical program conducted in several
countries (USA, Europe) which aims to assess the effective therapeutic dose of
Macuneos in order to slow disease progression in AMD patients in a Phase 2b
clinical trial. Prior to the interventional phase 2b study: MACA-INT, two
studies will be conducted simultaneously, which should begin in the second half
of 2018:
- On one hand, a pharmacokinetic and safety study in healthy volunteers and
   elderly patients; intermediate phase AMD (MACA-PK);
- On the other hand, an observational study aimed at characterizing the target
    population, and pre-recruiting patients (MACA-OBS), which will be
    conducted in Europe and the United States.
This clinical-regulatory protocol aims to (i) obtain clinical activity data as
early as 2018, (ii) to measure the pharmacokinetics of Macuneos, before
confirming the doses to be administered, (iii) to precisely characterize the
population, before confirming the inclusion criteria of the patients tested.

About MYODA:
MYODA is the name of drug candidate Sarconeos' new clinical development program
in Duchenne Muscular Dystrophy or Duchenne myopathy (DMD). Sarconeos is a drug
candidate that activates the MAS receptor, stimulates muscle anabolism and
reduces the appearance of muscle fibrosis, with the potential to suspend the
disease's progression, particularly to delay the loss of mobility. The clinical
development program will include a phase I/II pharmacokinetic study (MYODA-PK),
which is expected to begin in 2018, and a phase II/III study (MYODA-INT), which
is expected to start in 2019.

About BIOPHYTIS
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
laboratory.
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

Disclaimer
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
those contained in the forward looking statements, please refer to the Risk
Factors ("Facteurs de Risque") section of the Listing Prospectus upon the
admission of Company's shares for trading on the regulated market Euronext
Growth of Euronext Paris filed with the AMF, which is available on the AMF
website (www.amf- france.org) or on BIOPHYTIS' website (www.biophytis.com).

This press release and the information contained herein do not constitute an
offer to sell or a solicitation of an offer to buy or subscribe to shares in
BIOPHYTIS in any country. Items in this press release may contain forward-
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
prevail.

BIOPHYTIS
Stanislas VEILLET
CEO
contact@biophytis.com
Tel: +33 (0) 1 44 27 23 00

Citigate Dewe Rogerson
International media & Investors
Laurence BAULT/Antoine DENRY
Laurence.bault@citigatedewerogerson.com
antoine.denry@citigatedewerogreson.com
Tel: +33 (0)1 53 32 84 78
Mob: +33(0)6 64 12 53 61

LifeSci Advisors
Chris MAGGOS
Managing Director, Europe
chris@lifesciadvisors.com
Tel: +41 79 367 6254

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