Biophytis Presented its Phase 2-3 COVA Study Results in Severe Forms of Covid-19 at the WCID in Paris

Rhea-AI Summary

Biophytis presented the results of its Phase 2/3 COVA study on severe COVID-19 at the World Congress on Infectious Diseases in Paris, held from June 24-26, 2024. The study focused on the efficacy of BIO101 (20-hydroxyecdysone) in hospitalized patients. Results showed a 43.8% reduction in the risk of early respiratory failure or death, and a 44.6% reduction in the death rate over 90 days. The study highlighted a good safety profile for BIO101. The presentation comes as COVID-19 cases rise, with a noted 52% increase in ER visits in France during mid-June. The results position BIO101 as a promising treatment for severe COVID-19, especially in elderly patients with comorbidities.

Positive

• Phase 2/3 COVA study showed a 43.8% reduction in the risk of early respiratory failure or death.
• The study also reported a 44.6% reduction in the death rate over 90 days.
• BIO101 demonstrated a very good safety profile.

Negative

• None.

Insights

Medical Research Analyst

The results of Biophytis' Phase 2/3 COVA study offer promising news, especially for severe COVID-19 cases. The key takeaway is the statistically significant reduction in early respiratory failure or death by 43.8% and a 44.6% reduction in the death rate over 90 days among the treated patients. This is noteworthy because it suggests BIO101 could provide a substantial therapeutic benefit, particularly for vulnerable populations with severe COVID-19.

The drug's safety profile is another critical aspect. Ensuring that BIO101 is safe for use in severe cases adds considerable value, especially since adverse effects could complicate the already precarious conditions of severely ill patients. The data presented should attract attention from other researchers and clinicians focusing on COVID-19 treatment solutions.

Given the context of rising COVID-19 cases and the ongoing threat it poses, these findings can potentially alter treatment protocols in hospitals worldwide, particularly in regions experiencing new outbreaks. Retail investors should note that while the results are positive, further phases and regulatory approvals are necessary before the drug can be commercialized.

Market Research Analyst

The positive results from the Phase 2/3 COVA study provide a significant boost to Biophytis' market potential. This development places BIO101 as a leading candidate for treating severe COVID-19, which can expand the company's market share and revenue streams if it progresses to market approval. Investors might find this attractive as it represents a solid pipeline product with potential significant market impact.

In the short term, the positive news could lead to increased investor confidence and possibly a rise in stock prices due to the perceived value this successful trial adds to Biophytis' bio-pharmaceutical pipeline. In the long run, assuming continued successful trials and eventual regulatory approval, BIO101 could become a flagship product, driving substantial revenue growth.

However, it is essential to remain cautious. The biotech sector is highly volatile and the path from clinical success to market approval is fraught with regulatory challenges. Investors should keep an eye on subsequent trial phases and FDA or EMA feedback.

PARIS, FRANCE AND CAMBRIDGE, MA / ACCESSWIRE / July 1, 2024 / Biophytis SA (Euronext Growth Paris : ALBPS), ("Biophytis" or the "Company"), a clinical-stage biotechnology company specialized in the development of therapeutics for age-related diseases, presented the roll-out and results of its phase 2/3 COVA study in the treatment of severe forms of Covid-19 at the 6th edition of the World Congress on Infectious Diseases, held from June 24 to 26, 2024 in Paris, France.

Professor Valerie Pourcher MD, PhD, Chaiman of the Infectious Diseases department at Pitié Salpetriere, presented the COVAphase 2/3 clincial study results in a context where the number of Covid cases rises again. Dr. Claudia Ferreira MD, PhD, Medical Director at Biophytis, opened the conference with a keynote presentation on the risk of infectious diseases and further pandemic developments associated with the Paris Olympic games including an increase of +52 %in emergency room (ER) visits due to SARS-CoV-2 on the week of 10-17 June 2024 in France. She also chaired several roundtables.

Valerie Pourcher detailed the results of the randomised, placebo-controlled Phase 2/3 COVA study and the efficacy of oral BIO101 (20-hydroxyecdysone) administered orally in adult patients hospitalised for severe forms of COVID-19.

The results of this phase 2-3 study, evaluating BIO101 in the treatment of severe hospitalised COVID-19 patients, are positive and show, in addition to a very good safety profile, a statistically significant reduction in the relative risk of early respiratory failure or death of 43.8% and a 44.6% reduction in the death rate over 90 days.

Stanislas Veillet, CEO of Biophytis, stated: "The Covid pandemic is far from over: according to the World Health Organization, 134,797 new cases of Covid-19 and 1,691 deaths have been reported worldwide in the last 28 days as of June 9 - a figure that is underestimated due to under-reporting. Our COVA program, which showed very positive resullts, positions BIO101 (20-hydroxyecdysone) as a leading drug candidate for severe forms of Covid-19, particularly in elderly patients with co-morbidities, that is independent of the SARS-COV2 strain."

The poster presented at the Congress, which details the objectives, the design and the results of the study, can be viewed by clicking on this link.

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About BIOPHYTIS

Biophytis SA is a clinical-stage biotechnology company specializing in the development of drug candidates for age-related diseases. BIO101 (20-hydroxyecdysone), our lead drug candidate, is a small molecule in development for muscular (sarcopenia, phase 3 ready and Duchenne muscular dystrophy), respiratory (Covid-19 phase 2-3 completed) and metabolic diseases (obesity, phase 2 to be started). The company is based in Paris, France, and Cambridge, Massachusetts. The Company's ordinary shares are listed on Euronext Growth (Ticker: ALBPS -ISIN: FR0012816825). For more information, visit www.biophytis.com

Forward-looking statements

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. 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. 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 also refer to the "Risk and uncertainties the Company is to face» section from the Company's 2023 Financial Report available on BIOPHYTIS website (www.biophytis.com) and as exposed in the "Risk Factors" section of form 20-F as well as other forms filed with the SEC (Securities and Exchange Commission, USA). 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 contacts

Investor relations
Nicolas Fellmann, CFO
Investors@biophytis.com

Media

Antoine Denry:antoine.denry@taddeo.fr- +33 6 18 07 83 27
Nizar Berrada: nizar.berrada@taddeo.fr - +33 6 38 31 90 50

SOURCE: Biophytis

View the original press release on accesswire.com

FAQ

What were the results of Biophytis' Phase 2/3 COVA study on severe COVID-19?

The Phase 2/3 COVA study showed a 43.8% reduction in the risk of early respiratory failure or death and a 44.6% reduction in the death rate over 90 days, with a good safety profile for BIO101.

When and where were the Phase 2/3 COVA study results presented?

The results were presented at the World Congress on Infectious Diseases in Paris from June 24-26, 2024.

How did COVID-19 cases impact the timing of Biophytis' presentation?

The presentation was timely as it came amidst a resurgence of COVID-19 cases, with a 52% increase in ER visits in France during the week of June 10-17, 2024.

What is the significance of BIO101 (20-hydroxyecdysone) based on the Phase 2/3 COVA study?

BIO101 is positioned as a promising treatment for severe COVID-19, showing significant reductions in respiratory failure or death and overall mortality, especially in elderly patients with comorbidities.