BIOPHYTIS (EPA:ALBPS) - Biophytis Presents Positive Preclinical Data on Sarconeos (BIO101) in COVID-19 at ECCMID 2021

Transparency directive : regulatory news

12/07/2021 08:00

Press release

Biophytis Presents Positive Preclinical Data on Sarconeos (BIO101) in COVID-19
at ECCMID 2021

Paris, France, Cambridge (Massachusetts, United States), Monday 12, 2021, 8:00
am. CEST Biophytis SA (Nasdaq CM: BPTS, Euronext Growth Paris: ALBPS),
("Biophytis" or the "company"), a clinical-stage biotechnology company focused
on the development of therapeutics that are aimed at slowing the degenerative
processes associated with aging and improving functional outcomes for patients
suffering from age-related diseases, including severe respiratory failure in
patients suffering from COVID-19 today announces new positive preclinical data
on Sarconeos (BIO101) in hamsters infected with SARS-CoV-2.

The data will be presented as an ePoster at the 31st European Congress of
Clinical Microbiology & Infectious Diseases (ECCMID), which will take place
online from 9-12 July 2021. This study reveals that Sarconeos (BIO101) daily
treatment prevents respiratory function deterioration in SARS-CoV-2-infected
mammals and provides a solid preclinical proof of concept for the ongoing Phase
2-3 COVA clinical study.

Stanislas Veillet, President and CEO of Biophytis, said: "These preclinical
data are further evidence of the potential of Sarconeos (BIO101) to be an
effective treatment for patients with COVID-19. We are continuing our COVA
Phase 2-3 study with Sarconeos (BIO101) in patients infected with COVID-19 and
are looking forward to results of the second interim analysis in Q3 2021. We
are prepared to rapidly scale up capacity, should we receive regulatory
approval for Sarconeos (BIO101) in COVID-19, having secured contracts with a
major global Custom Development and Manufacturing Organization (CDMO) for the
manufacturing of registration batches."

In the study, hamsters were inoculated intranasally with 106 TCID50/mL.
Sarconeos (BIO101) was administered daily at 10 mg/kg*day. Three groups of
6-7-week-old female hamsters were compared: uninfected hamsters treated with
the vehicle (control; n=10), SARS-CoV-2-infected hamsters treated with the
vehicle (n=10), and SARS-CoV-2-infected hamster treated with BIO101 (n=10).
Pulmonary function was assessed by whole-body plethysmography.

The results showed that at 5 dpi, the Penh value, a classical measure of
respiratory distress proven to be relevant in corona virus airway infections,
was significantly increased in the group of SARS-CoV-2-infected hamsters
treated with the vehicle, compared to the uninfected control group (0.63 ±
0.11 versus 0.28 ± 0.01, p<0.01). In animals treated with Sarconeos (BIO101),
the Penh value was significantly reduced compared to vehicle-treated infected
animals (0.35 ± 0.02, p<0.05). Inspiration (66.4 ± 2.6 msec) and expiration
(134.9 ± 3.2 msec) times in Sarconeos (BIO101)-treated animals were
significantly lower than in the vehicle-treated group of infected hamsters
(88.4 ± 6.87 msec, p<0.01; 150.7 ± 5.2 msec, p<0.05, respectively).

End Expiratory Pause (EEP) is proportional to the degree of obstruction of the
lower airways. In Sarconeos (BIO101)-treated animals, EEP time was
significantly lower compared to infected animals treated with the vehicle (12.6
± 0.3 vs 18.8 ± 1.6 msec, p<0.01). The daily administration of BIO101 for 5
days remarkably restored the EEP time of the treated animals (CI 95%: 11.9-
13.4), to a comparable level of uninfected control animals (CI 95%:
11.3-13.4).

About BIOPHYTIS
Biophytis SA is a clinical-stage biotechnology company specialized in the
development of therapeutics that are aimed at slowing the degenerative
processes associated with aging and improving functional outcomes for patients
suffering from age-related diseases, including severe respiratory failure in
patients suffering from COVID-19.
Sarconeos (BIO101), our leading drug candidate, is a small molecule,
administered orally, being developed as a treatment for sarcopenia in a Phase 2
clinical trial in the United States and Europe (SARA-INT). It is also being
studied in a clinical two-part Phase 2-3 study (COVA) for the treatment of
severe respiratory manifestations of COVID-19 in Europe, Latin America, and the
US. A pediatric formulation of Sarconeos (BIO101) is being developed for the
treatment of Duchenne Muscular Dystrophy (DMD). The company is based in Paris,
France, and Cambridge, Massachusetts. The company's common shares are listed on
Euronext Growth (Ticker: ALBPS - ISIN: FR0012816825) and ADSs are listed on
Nasdaq Capital Market (Ticker BPTS - ISIN: US09076G1040). For more information
visit www.biophytis.com

Disclaimer
This press release contains forward-looking statements. Forward-looking
statements include all statements that are not historical facts. In some cases,
you can identify these forward-looking statements by the use of words such as
"outlook," "believes," "expects," "potential," "continues," "may," "will,"
"should," "could," "seeks," "predicts," "intends," "trends," "plans,"
"estimates," "anticipates" or the negative version of these words or other
comparable words. These forward-looking statements include statements regarding
Biophytis' anticipated timing for its various Sarconeos (BIO101) clinical
trials and expectations regarding commercialization. Such forward-looking
statements are based on assumptions that Biophytis considers to be reasonable.
However, there can be no assurance that the statements contained in such
forward-looking statements will be verified, which are subject to various risks
and uncertainties including, without limitation, delays in patient recruitment
or retention, interruptions in sourcing or supply chain, its ability to obtain
the necessary regulatory authorizations, COVID- 19-related delays, and the
impact of the current pandemic on the Company's clinical trials. The
forward-looking statements contained in this press release are also subject to
risks not yet known to Biophytis or not currently considered material by
Biophytis. Accordingly, there are or will be important factors that could cause
actual outcomes or results to differ materially from those indicated in these
statements. Please refer to the "Risk Factors" section of the Company's Annual
2020 Report available on BIOPHYTIS website (www.biophytis.com) and to the risks
discussed in the Company's registration statement on Form F-1 and other reports
filed with the Securities and Exchange Commission (the "SEC"). We undertake no
obligation to publicly update or review any forward-looking statement, whether
as a result of new information, future developments or otherwise, except as
required by law.

Biophytis Contact for Investor Relations
Evelyne Nguyen, CFO
E : evelyne.nguyen@biophytis.com

Media contact
Life Sci Advisors
Sophie Baumont/Chris Maggos
E: sophie@lifesciadvisors.com
T: +33 6 27 74 74 49

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BIOPHYTIS (EPA:ALBPS) - Biophytis Presents Positive Preclinical Data on Sarconeos (BIO101) in COVID-19 at ECCMID 2021

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