PARIS and CAMBRIDGE, Mass., July 12, 2021 (GLOBE NEWSWIRE) -- 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).
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
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.
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