Sarconeos (BIO101) / Biophytis - LARVOL DELTA

Drug Candidate BIO101 for Spinal Muscular Atrophy as Monotherapy or Combined With the Antisense Oligonucleotide ASO-10-27. (PubMed, J Cachexia Sarcopenia Muscle) - "We showed that BIO101 constitutes an efficient SMN-independent therapy to improve muscle performance in SMA, which could open new therapeutic avenues for patients in combination with SMN-based therapies, or as monotherapy for less severe forms."

Journal • Monotherapy • CNS Disorders • Fatigue • Genetic Disorders • Movement Disorders • Muscular Atrophy • Rare Diseases

Biophytis Secures public funding in Brazil for Obesity Phase 2 Trial and Signs Agreements with Leading local Clinical Partners (Biophytis Press Release) - "With 122 of the 164 patients planned to be recruited in Brazil, the region is central to the success of the OBA trial. The agreements with FARMAVAX-UFMG and FMRP-USP provide Biophytis with: Access to leading clinical expertise in obesity and metabolic disorders, A large and diverse patient population for efficient recruitment...This partnership will provide non-dilutive funding for the OBA Phase 2 trial....Biophytis remains focused on: Finalizing additional site agreements in Europe to complete its site network; Securing final regulatory approvals from ANVISA and EMA; Initiating patient enrolment in the OBA Phase 2 trial across both regions."

Commercial • Financing • New P2 trial • Obesity

Neuroprotective Effect of Mas Activation by BIO101 in Vincristine-Induced Small Fiber Neuropathy. (PubMed, J Peripher Nerv Syst) - "Therefore, BIO101 emerges as a safe and promising preventive treatment against vincristine-induced small fiber neuropathy."

Journal • Neuralgia • Oncology • Pain • Peripheral Neuropathic Pain

Biophytis obtains EMA authorization to launch its Phase 2 clinical trial in obesity (Biophytis Press Release)

New P2 trial • Obesity

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