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Biophytis Reports H1 2021 Financial Results and Provides Business Update

Nachrichtenquelle: globenewswire
17.09.2021, 08:00  |  286   |   |   

  • SARA-INT: Positive top line results of Phase 2 study demonstrate efficacy of Sarconeos (BIO101) in sarcopenia and support progress into Phase 3
  • COVA: DMC second interim analysis shows efficacy results in the promising zone allowing continuation of the phase 2/3 study with Sarconeos (BIO101) in COVID-19. Top line results of the full study are expected in Q1 2022
  • Manufacturing scale up signed with a major global CDMO to increase potential supply of Sarconeos (BIO10) in anticipation of COVA positive results
  • Biophytis leadership team reinforced with new senior appointments
  • Cash on hand increased to €23 million as of June 30th 2021, compared to €18.8 million as of December 31 2020, following successful IPO on Nasdaq in February 2021. In addition, new convertible bond financing of €32 million signed with Atlas

PARIS and CAMBRIDGE, Mass., Sept. 17, 2021 (GLOBE NEWSWIRE) -- Biophytis SA (NasdaqCM: BPTS, Euronext Growth Paris: ALBPS), a clinical-stage biotechnology company focused on the development of therapeutics that slow the degenerative processes associated with aging and improve functional outcomes for patients suffering from age-related diseases, including severe respiratory failure in patients suffering from COVID-19, today publishes its interim financial report for the first half of 2021 and provides updates on key operational developments and financing transactions.

Stanislas Veillet, CEO of Biophytis, said: “During the first half of 2021 Biophytis reached a major milestone with positive results from the SARA-INT Phase 2 trial, which demonstrated the efficacy of Sarconeos (BIO101) in sarcopenia. Indeed Sarconeos (BIO101) at the highest dose (350 mg bid) showed a clinically meaningful improvement in the 400-meter walk test (400MWT), the primary endpoint of the study. We are now committed to progressing Sarconeos (BIO101) into phase 3 for this indication either alone or through partnerships with pharmaceutical companies.

Moreover, recommendations from DMC a few days ago for our COVA study to continue without any modification, based upon efficacy results in the promising zone following the second interim analysis, are very encouraging. We hope that Sarconeos (BIO101) will become one of the first drug candidates able to restore breathing capabilities for hospitalized patients in severe conditions, and therefore avoiding their admission to ICUs. The whole Company is now focused on the next milestones, ie complete the trial as soon as possible, as well as industrial scaling up and regulatory approvals in Europe, USA and Brazil. We want to be ready for commercialization of our Sarconeos (BIO101) in COVID-19 first half of 2022.

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Biophytis Reports H1 2021 Financial Results and Provides Business Update SARA-INT: Positive top line results of Phase 2 study demonstrate efficacy of Sarconeos (BIO101) in sarcopenia and support progress into Phase 3COVA: DMC second interim analysis shows efficacy results in the promising zone allowing continuation of …

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