Sarconeos (BIO101) / Biophytis - LARVOL DELTA

Presentation of OBA: a phase 2 clinical trial testing the drug candidate BIO101 (20E) to limit the loss of muscle mass and function induced by semaglutide in patients with obesity (ECO 2025) - P2 | "Introduction: Survodutide is a unimolecular dual glucagon/glucagon-like peptide-1 receptor (GCGR/GLP-1R) agonist in phase 3 clinical trials for chronic weight management in people living with obesity and, separately, for treating people with metabolic dysfunction-associated steatohepatitis. In this pre-specified exploratory analysis of a phase 2 trial, treatment with the dual GCGR/GLP-1R agonist survodutide was associated with improvements in molecular markers of cardiometabolic health and cardiovascular risk in people living with obesity."

Clinical • P2 data • Atherosclerosis • Cardiovascular • Diabetes • Genetic Disorders • Hepatology • Inflammation • Metabolic Dysfunction-Associated Steatohepatitis • Obesity • CCL18 • CRP • ICAM1 • LEP

BIO101 in Sarcopenic Seniors at Risk of Mobility Disability: Results of a Double-Blind Randomised Interventional Phase 2b Trial. (PubMed, J Cachexia Sarcopenia Muscle) - "After 6 to 9 months of treatment, BIO101 350 mg bid showed strong trends consistent with a clinically relevant effect on the 400MWT GS, close to the minimal clinically important difference (MCID) in sarcopenia (0.1 m/s). This was also shown in predefined subpopulations at higher risk of mobility disability. BIO101 showed a good safety profile. Taken together, efficacy and safety data of this Phase 2 trial encourage us to pursue further development of BIO101 for the treatment of sarcopenia."

Clinical • Journal • P2b data • Infectious Disease • Novel Coronavirus Disease • Obesity • Sarcopenia

Efficacy of oral 20-hydroxyecdysone (BIO101), a MAS receptor activator, in adults with severe COVID-19 (COVA): a randomized, placebo-controlled, phase 2/3 trial. (PubMed, EClinicalMedicine) - P2/3 | "BIO101 significantly reduced the risk of death or respiratory failure supporting its use in adults hospitalized with severe respiratory symptoms due to COVID-19. Biophytis."

Journal • P2/3 data • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

BIO101 stimulates myoblast differentiation and improves muscle function in adult and old mice. (PubMed, J Cachexia Sarcopenia Muscle) - "Our data suggest beneficial anabolic and pro-differentiating effects of BIO101 rendering BIO101 a potent drug candidate for treating sarcopenia and possibly other muscle wasting disorders."

Journal • Preclinical • Sarcopenia • Myogenin

Cost-saving potential of BIO101 treatment in hospitalized adult patients with severe COVID-19. (ERS 2023) - No abstract available

Clinical • HEOR • Infectious Disease • Novel Coronavirus Disease

Effect of Pharmacologic Therapeutics in Sarcopenic Patients with Chronic Kidney Disease (KSN 2023) - "These conditions inducethe activation of NF-kB and MAPK pathway, ATP-UPS, and ROS system, resulting in the proteincatabolism (decreased protein synthesis and increased protein degradation).There have been many drugs which were developed to prevent or treat sarcopenia (general).However, only a few of them, i.e., Bimagrumab from Novartis and Sarconeos from Biophytis SAS,reported recent results and showed the effectiveness in terms of adiposity, metabolic disturbances,and walking test in limited criteria of participants in 2021 and 2022.The main interventions for prevention and treatment of sarcopenia in Chronic kidney disease (CKD)are aerobic and resistance exercises along with nutritional interventions...Reduced exercise capacity, decreased PGC-1α,increased mitochondrial autophagy was restored by AST-120. AST-120 restored the epithelial tightjunction proteins and reduced plasma endotoxin and markers of oxidative stress and inflammation.AST-120 administration also changed..."

Clinical • Chronic Kidney Disease • Inflammation • Metabolic Disorders • Muscular Atrophy • Nephrology • Obesity • Renal Disease • Sarcopenia • Targeted Protein Degradation • FBXO32 • IL6 • KL • TGFB1 • TNFA

A Phase 1 study for safety and pharmacokinetics of BIO101 (20-hydroxyecdysone) in healthy young and older adults. (PubMed, J Cachexia Sarcopenia Muscle) - "BIO101 shows a good safety and pharmacokinetic profile that led to the selection of doses for the subsequent interventional clinical trials of Phase 2 in age-related sarcopenia (SARA-INT) and Phase 3 in Covid-19 (COVA)."

Journal • P1 data • PK/PD data • Infectious Disease • Novel Coronavirus Disease • Sarcopenia • MB

COVA: Testing the Efficacy and Safety of BIO101 for the Prevention of Respiratory Deterioration in COVID-19 Patients (clinicaltrials.gov) - P2/3 | N=238 | Terminated | Sponsor: Biophytis | Active, not recruiting ➔ Terminated; Lack of eligible patients due to lower number of Covid-19 cases in all involved sites.

Trial termination • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IL6

Combination of BIO101 with antisense oligonucleotide therapy demonstrates synergistic beneficial effects in severe SMA-like mice (WMS 2022) - "Most importantly, the co-treated SMA-like mice improved their moving capacity (+40%) and their fatigue resistance (4,2-fold) compared to SMA-like mice treated only with ASO. These results provide strong evidence that BIO101, with beneficial effects on the entire motor unit, constitutes an efficient SMN-expression-independent therapy for improving muscle function and should be considered as a potential combinatorial option for a new therapeutic strategy in SMA patient."

Preclinical • CNS Disorders • Fatigue • Genetic Disorders • Movement Disorders • Muscular Atrophy • Rare Diseases

Combination of antisense oligonucleotide therapy with BIO101 demonstrates synergistic beneficial effects in severe SMA-like mice (ICNMD 2022) - No abstract available

Preclinical

COVA: Testing the Efficacy and Safety of BIO101 for the Prevention of Respiratory Deterioration in COVID-19 Patients (clinicaltrials.gov) - P2/3 | N=310 | Active, not recruiting | Sponsor: Biophytis | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2021 ➔ Sep 2022 | Trial primary completion date: Dec 2021 ➔ Jun 2022

Enrollment closed • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IL6 • TNFA

COVA: Testing the Efficacy and Safety of BIO101 for the Prevention of Respiratory Deterioration in COVID-19 Patients (clinicaltrials.gov) - P2/3; N=310; Recruiting; Sponsor: Biophytis; Trial completion date: Sep 2021 ➔ Dec 2021; Trial primary completion date: Jul 2021 ➔ Dec 2021

Clinical • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IL6 • TNFA

A Double-blind, Placebo Controlled, Randomized INTerventional Clinical Trial (SARA-INT) (clinicaltrials.gov) - P2; N=233; Completed; Sponsor: Biophytis; Active, not recruiting ➔ Completed

Trial completion • Genetic Disorders • Movement Disorders • Obesity • Sarcopenia

Biophytis Secures the Manufacturing of Sarconeos (BIO101) for COVID-19 with a Global CDMO & Announces the Next Milestones for the COVA Phase 2-3 Study (GlobeNewswire) - "Biophytis SA...has secured contracts with a major global Custom Development and Manufacturing Organization (CDMO) for the manufacturing of registration batches of Sarconeos (BIO101)....Results of this second interim analysis (IA2) as regards to safety and efficacy are now expected in Q3 2021....Beyond the second interim analysis based on 155 patients, the Company is pursuing the recruitment of patients...176 patients have been recruited in total over the 310 required for the release of the full results. Top line results for the full study are now expected in Q4 2021, in view of a potential filing for Emergency Use Authorization and Conditional market Approval applications respectively with FDA and EMA by year end. Commercialization should then start beginning of 2022."

Commercial • European regulatory • FDA event • P3 data: top line • Infectious Disease • Novel Coronavirus Disease

BIOPHYTIS Completed Recruitment of 155 Participants to the COVA Phase 2-3 Study with Sarconeos (BIO101) in COVID-19 allowing the 2nd Interim Analysis (GlobeNewswire) - "BIOPHYTIS SA...announces it has recruited the 155th participant for Part 2 of its COVA Phase 2-3 study of Sarconeos (BIO101) in patients infected with COVID-19. Recruitment of the 155th participant allows for the independent Data Monitoring Committee (DMC) to conduct its second interim analysis...The Company is to report the recommendations of the DMC based on its review of the second interim analysis results by the end of Q2 2021....Recruitment into Part 2 of the study continues to proceed in France and Brazil to complete enrollment of 310 participants...The final study results are expected in Q3 2021...The final sample size will depend upon DMC recommendations from the second interim analysis."

Enrollment status • P2 data • P2/3 data • Infectious Disease • Novel Coronavirus Disease

Biophytis Gives Operational Perspectives on its Sarconeos (BIO101) Ahead of its Upcoming AGM on April 26, 2021 (GlobeNewswire) - "Biophytis SA...today provides updates and perspectives on its Sarconeos (BIO101) programs ahead of its upcoming General Assembly on April 26, 2021. The COVA phase 2-3 study against COVID-19: Assuming Emergency Use Authorization from the US, and Conditional Market Approval from EMA are obtained in Q3 2021, marketing preparation could possibly start by end of 2021. Most of the commercialization would be envisaged from the start of 2022. In that perspective, Biophytis is currently taking steps in order to prepare for industrial scale ups and manufacturing with potential CMO partners in due course."

Commercial • European regulatory • FDA event • Infectious Disease • Novel Coronavirus Disease

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BIOPHYTIS Gives Updates on its Phase 2-3 COVA Study on COVID-19 (GlobeNewswire) - "...the independent Data Monitoring Committee (DMC) for the COVA study has delivered a favorable opinion on the safety of Sarconeos (BIO101) in patients infected with COVID-19, following the scheduled interim analysis of the 50 participants from Part 1 of the study, as well as the progression of patients enrollment, which has now reached 97 of the 155 planned for the second interim analysis. A total of 28 clinical centers of the 30 targeted are now opened and recruiting in the United States, Brazil, France and Belgium."

DSMB • Enrollment status • Infectious Disease • Novel Coronavirus Disease

Biophytis Reports 2020 Full Year Results (GlobeNewswire) - "The COVA study....Subject to any COVID-19 related delays, the Company anticipates applying for Emergency Use Authorization from FDA, and Conditional Market Approval from EMA in Q2 2021....MYODA clinical program in Duchenne Muscular Dystrophy (DMD)....Depending on the evolution of the pandemic and its impact on our operational capabilities, the MYODA study is expected to start in H1 2021."

European regulatory • FDA event • New trial • Duchenne Muscular Dystrophy • Infectious Disease • Novel Coronavirus Disease

Developing new drugs that activate the protective arm of the renin angiotensin system as a potential treatment for respiratory failure in COVID-19 patients. (PubMed, Drug Discov Today) - "We review clinical strategies that are attempting to rebalance the RAS in COVID-19 patients by using ACE inhibitors, angiotensin receptor blockers, or agonists of {AuQ: Edit OK?} angiotensin-II receptor type 2 or Mas receptor (MasR). We also propose that the new MasR activator BIO101, a pharmaceutical grade formulation of 20-hydroxyecdysone that has anti-inflammatory, anti-fibrotic and cardioprotective properties, could restore RAS balance and improve the health of COVID-19 patients who have severe pneumonia."

Clinical • Journal • Review • Fibrosis • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

Biophytis Announces Expansion of Patient Recruitment for Part 2 of the Phase 2-3 COVA Trial ("COVA Study") Following Regulatory Authorities Approvals in France and Belgium (GlobeNewswire) - "Biophytis SA...announces that patient recruitment will begin in France and Belgium for Part 2 of its COVA Study assessing Sarconeos...Similar authorizations are now obtained in France and in Belgium, from the respective Regulatory Authorities. That brings to four the number of countries in which the COVA Study is now recruiting for Part 2: France, Belgium, Brazil and the United States, following the completion of patient enrollment for Part 1, which is now achieved with 50 participants."

Enrollment status • Infectious Disease • Novel Coronavirus Disease

Biophytis Announces Pricing of $20.1 Million U.S. Initial Public Offering of American Depositary Shares and Approval to List on Nasdaq Capital Market (BioSpace) - "Biophytis...announces the pricing of its previously announced U.S. initial public offering of 12,000,000 new ordinary shares...The offering is expected to close on or about February 12, 2021...Biophytis currently expects to use the net proceeds from the ADS Offering, as follows: approximately $10.0 million to finalize part 2 of its COVA trial of Sarconeos (BIO101) in respiratory failures linked to COVID-19...Approximately $2.0 million to commence its development of Sarconeos (BIO101) in DMD..."

Financing • Duchenne Muscular Dystrophy • Infectious Disease • Novel Coronavirus Disease

Biophytis Announces the Start of Patient Recruitment in Brazil and the USA for Part 2 of the Phase 2-3 COVA Trial (“COVA Study”) (GlobeNewswire) - "Biophytis SA...announces that patient recruitment at most clinical centers in Brazil and the United States will begin for Part 2 of its COVA Study assessing Sarconeos...Enrollment for Part 1 of the COVA Study has been completed with 50 patients recruited in 4 countries: Brazil, the USA, Belgium, and France. Following the Data Monitoring Committee ('DMC') recommendation to begin the recruitment for Part 2, authorization is being obtained from regulatory authorities...in Brazil and the USA for the start of Part 2. Similar authorizations are being pursued in France, Belgium and the UK."

Enrollment status • Trial status • Infectious Disease • Novel Coronavirus Disease

Biophytis Announces Public Filing of a Registration Statement for Proposed Initial Public Offering in the United States (GlobeNewswire) - "Biophytis SA...announces that it has publicly filed yesterday after closing of the market in Paris a registration statement on Form F-1 with the U.S. Securities and Exchange Commission (the 'SEC') in relation to a proposed initial public offering of ordinary shares...As reflected in the Form F-1 filed with the SEC, Biophytis currently expects to use the net proceeds from the ADS Offering as follows: to finalize part 2 of its COVA trial of Sarconeos (BIO101) in respiratory failures linked to COVID-19...To commence its development of Sarconeos (BIO101) in DMD (with enrollment of the first patient in the trial) following IND approval from the FDA and EMA, subject to better control of COVID-19 in Europe and the United States."

Financing • Duchenne Muscular Dystrophy • Infectious Disease • Novel Coronavirus Disease

BIOPHYTIS receives DMC recommendation for starting recruitment for Part 2 of its Phase 2-3 COVA study in COVID-19 (GlobeNewswire) - "Interim Analysis on Part 1 is expected in Q1 2021; BIOPHYTIS SA...announces the recommendation by the DMC to start recruitment for Part 2 of Phase 2-3 of the COVA Study. The COVA Study assesses Sarconeos (BIO101) as a potential treatment for acute respiratory failure associated with COVID-19. The DMC’s recommendation is based on its review of the safety data analysis from the first 20 patients enrolled in the study....BIOPHYTIS intends to start patient recruitment for Part 2 of the COVA Study in countries where applicable regulatory approvals or permissions, including Institutional Review Board/Ethics Committee approvals, are obtained....Results from the full study (Part 1 and Part 2) are expected in Q2 2021, subject to any COVID-19 related delays and the impact of the current pandemic."

DSMB • P2 data • P2/3 data • Infectious Disease • Novel Coronavirus Disease