Adaptive design phase 2 to 3, randomized, double- blind, multicenter, to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of BIO101 in the prevention of the respiratory deterioration in hospitalized patients with COVID-19 pneumonia (severe stage)

Start Date01 Oct 2020

Sponsor / Collaborator-

NCT04472728 / TerminatedPhase 2/3

Adaptive Design Phase 2 to 3, Randomized, Double-blind, to Evaluate Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of BIO101 in the Prevention of the Respiratory Deterioration in Hospitalized COVID-19 Patients

The COVA clinical study is a global multicentric, double-blind, placebo-controlled, group sequential and adaptive 2 parts phase 2-3 study targeting in patients with SARS-CoV-2 pneumonia. Part 1 is a Phase 2 exploratory Proof of Concept (PoC) study to provide preliminary data on the activity, safety and tolerability of BIO101 in the target population. Part 2 is a phase 3 pivotal randomized study to provide further evidence of safety and efficacy of BIO101 after 28 days of double-blind dosing. BIO101 is the investigational new drug that activates the Mas receptor (MasR) through the protective arm of the Renin Angiotensin System (RAS).

Start Date26 Aug 2020

Sponsor / Collaborator

Biophytis SA

EUCTR2020-001498-63-FR / Unknown statusPhase 2

Start Date22 Jul 2020

Sponsor / Collaborator-

100 Clinical Results associated with Ruvembri

100 Translational Medicine associated with Ruvembri

100 Patents (Medical) associated with Ruvembri

Literatures (Medical) associated with Ruvembri

01 Jun 2018·Food science & nutritionQ3 · AGRICULTURAL & FORESTRY SCIENCE

Scaling‐up biofortified beans high in iron and zinc through the school‐feeding program: A sensory acceptance study with schoolchildren from two departments in southwest Colombia

Q3 · AGRICULTURAL & FORESTRY SCIENCE

ArticleOA

Author: Talsma, Elise F. ; Londoño‐Hernandez, Luis F. ; Beintema, Joni J. S. ; Gallego‐Castillo, Sonia ; Restrepo‐Manjarres, José

Abstract:

Iron and zinc deficiencies are global health problems, affecting mostly pregnant women and young children. In 2016, biofortified iron and zinc beans were introduced in Colombia. The incorporation of biofortified beans into the national school‐feeding program could facilitate adoption and potentially improve the nutritional status of large populations. However, biofortified beans have to be accepted in order to be consumed by populations. We therefore studied the sensory acceptability of two biofortified beans, BIO‐101 and BIO‐107, and local beans at schools with free feeding services in two departments of southwest Colombia. Measured on a five‐point Likert scale, the mean overall scores were 3.88 ± 0.64, 3.79 ± 0.74, and 3.81 ± 0.76, for BIO‐101, BIO‐107, and the local bean varieties, respectively, without significant differences. The children in Piendamó (Cauca) slightly preferred BIO‐107 over the local bean (p < .05) based on color, smell, and taste. The children in Caicedonia (Valle del Cauca) slightly favored the local bean over BIO‐107 (p < .05), regarding size, smell, and taste. Overall acceptability in schoolchildren was good for all beans without significant differences. This study advocates incorporation of accepted biofortified beans in the school‐feeding program, in order to reach large groups of schoolchildren and potentially improve their nutritional statuses.

Foods (Basel, Switzerland)Q2 · AGRICULTURAL & FORESTRY SCIENCE

Apitherapy for Age-Related Skeletal Muscle Dysfunction (Sarcopenia): A Review on the Effects of Royal Jelly, Propolis, and Bee Pollen

Q2 · AGRICULTURAL & FORESTRY SCIENCE

ReviewOA

Author: Kunugi, Hiroshi ; Ali, Amira Mohammed

The global pandemic of sarcopenia, skeletal muscle loss and weakness, which prevails in up to 50% of older adults is increasing worldwide due to the expansion of aging populations. It is now striking young and midlife adults as well because of sedentary lifestyle and increased intake of unhealthy food (e.g., western diet). The lockdown measures and economic turndown associated with the current outbreak of Coronavirus Disease 2019 (COVID-19) are likely to increase the prevalence of sarcopenia by promoting sedentarism and unhealthy patterns of eating. Sarcopenia has multiple detrimental effects including falls, hospitalization, disability, and institutionalization. Although a few pharmacological agents (e.g., bimagrumab, sarconeos, and exercise mimetics) are being explored in different stages of trials, not a single drug has been approved for sarcopenia treatment. Hence, research has focused on testing the effect of nutraceuticals, such as bee products, as safe treatments to prevent and/or treat sarcopenia. Royal jelly, propolis, and bee pollen are common bee products that are rich in highly potent antioxidants such as flavonoids, phenols, and amino acids. These products, in order, stimulate larval development into queen bees, promote defenses of the bee hive against microbial and environmental threats, and increase royal jelly production by nurse bees. Thanks to their versatile pharmacological activities (e.g., anti-aging, anti-inflammatory, anticarcinogenic, antimicrobial, etc.), these products have been used to treat multiple chronic conditions that predispose to muscle wasting such as hypertension, diabetes mellitus, cardiovascular disorder, and cancer, to name a few. They were also used in some evolving studies to treat sarcopenia in laboratory animals and, to a limited degree, in humans. However, a collective understanding of the effect and mechanism of action of these products in skeletal muscle is not well-developed. Therefore, this review examines the literature for possible effects of royal jelly, bee pollen, and propolis on skeletal muscle in aged experimental models, muscle cell cultures, and humans. Collectively, data from reviewed studies denote varying levels of positive effects of bee products on muscle mass, strength, and function. The likely underlying mechanisms include amelioration of inflammation and oxidative damages, promotion of metabolic regulation, enhancement of satellite stem cell responsiveness, improvement of muscular blood supply, inhibition of catabolic genes, and promotion of peripheral neuronal regeneration. This review offers suggestions for other mechanisms to be explored and provides guidance for future trials investigating the effects of bee products among people with sarcopenia.

News (Medical) associated with Ruvembri

20 Jun 2024

·www.biospace.com

Biophytis grants Blanver Exclusive Rights to BIO101 in Latin America in Deal Valued at up to €108 Million

Biophytis to receive upfront and milestones payments for a total amount up to €108 million, as well as double-digit royaltieson future sales of the product Agreement covers commercialization of BIO101 in Latin America Biophytis and Blanver intend to collaborate on manufacturing and joint clinical development for Latin America PARIS, FRANCE AND CAMBRIDGE, MA / ACCESSWIRE / June 20, 2024 / Biophytis SA (Euronext Growth Paris:ALBPS), ("Biophytis" or the "Company"), a clinical-stage biotechnology company specialized in thedevelopment oftherapeutics for age-related diseases, today announces the signature of an exclusive license agreement with Blanver, one of the leading and most trusted pharmaceutical company in Brazil, for BIO101 (20-Hydroxyecdysone) in Latin American including, but not limited to Brazil, Mexico, Argentina and Colombia. The agreement provides that Blanver will be responsible for the registration, marketing and commercialization of BIO 101 (20-Hydroxyecdysone) in its various indications: obesity, respiratory infections due to Covid-19, sarcopenia and Duchenne Muscular Dystrophy (DMD) - once Biophytis has successfully completed the planned clinical development programmes for its drug candidate. With 40 years of history, Blanver has become an expert in infectious diseases, osteoporosis and metabolic disorders, which is a perfect match with Biophytis. In addition of Brazil, Blanver has an extensive network of unique distributors that covers the whole Latin America region. Under the terms of this partnership, Biophytis will be able to receive up to €108 million including an upfront payment and further additional payments if certain objectives are achieved. Biophytis is also eligible to receive double-digit royalties on net sales of BIO101 (20-Hydroxyecdysone) generated in the collaboration territory, after obtaining future marketing authorisations. This collaboration in one of the main pharma regions in the world, underscores the potential of BIO101 (20-Hydroxyecdysone) which is based on the positive clinical results already obtained in several indications. Stanislas Veillet, CEO of Biophytis, stated: "I warmly welcome this new partnership which is a key milestone that will enable Biophytis to further deploy its strategic roadmap, especially in obesity. This is a unique opportunity for both companies and comes at a crucial time as Brazil is the most fast-growing pharmaceutical market, representing more than $23 billion in 2023. In the LATAM region, 100 million of patients are suffering from obesity. We look forward to continuing our clinical and regulatory development work with Blanver over the coming months and to exploring with them early market access opportunities for our most advanced indications. Together, we aim to deliver solutions to patients and physicians over the years ahead." Sergio Frangioni, CEO of Blanver, commented: "Innovation is part of the Blanver DNA, and we are thrilled to partner with Biophytis, to bring this unique medicine in Latin America. We are very confident that the clinical study of the novel BIO101 (20-hydroxyecdysone), will show encouraging results, which will support the medical community to obesity, their effects and bring health and quality of life to so many patients who suffer from this condition." **** 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 About BLANVER Blanver Farmoquímica e Farmacêutica S.A. is a Brazilian company, founded in 1984, focused on R&D, manufacture and sale of innovative medicines and active pharmaceutical ingredients (APIs). The company plays in the segments of HIV, Hepatitis, Oncology, Hematology and Rare Disease, providing high quality products for expanding the population's access to medicines through partnerships with the Ministry of Health and official laboratories. Blanver is committed in always looking for innovations that will improve people's health and quality of life. 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 thesewords 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 ( ) 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 Pharma partners Edouard Bieth, CBO edouard.bieth@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 Blanver contacts Investor relations Sergio José Frangioni, CEO Media Herbert Silva: Herbert.silva@blanver.com.br Lilia Lima de Almeida: lilia.almeida@blanver.com.br SOURCE: Biophytis View the original press release on accesswire.com

License out/inPhase 2

12 Jun 2024

·www.biospace.com

Biophytis Announces the Successful Industrial Transfer of BIO101 (20-hydroxyecdysone) Production by its Service Provider Seqens

PARIS, FRANCE AND CAMBRIDGE, MA / ACCESSWIRE / June 12, 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, announces the successful transfer of BIO101 (20-hydroxyecdysone) production to industrial scale by Seqens. Seqens, an integrated global player in solutions and ingredients for the pharmaceutical and speciality markets, offering a broad portfolio of active ingredients, pharmaceutical intermediates and speciality products, has produced the first GMP-compliant batch of BIO101 (20-hydroxyecdysone) at its plant in Villeneuve La Garenne (Île-de-France). This batch is now available for use in Biophytis' clinical development programme to treat respiratory deterioration in patients with Duchenne Muscular Dystrophy (DMD). DMD is a rare genetic disease that causes severe and progressive muscle degeneration, mainly affecting boys. BIO101 (20-hydroxyecdysone) has significant potential to improve respiratory capacity and quality of life in non-ambulatory patients in the advanced stages of the disease. Stanislas Veillet, CEO of Biophytis, stated: "This is a crucial step in the development of our drug candidate. The successful transfer of production to industrial scale by Seqens strengthens our ability to provide unique therapeutic solutions. It also reflects our commitment to collaborate with leading partners to accelerate the development and availability of innovative treatments and the launch of our clinical programmes in Duchenne muscular dystrophy." Biophytis, which has already orphan drug designation in Europe and the United States in the DMD indication and has refined its protocol, submitted to the European and American regulatory agencies, is seeking partners and funding to launch a phase 1-2 clinical trial in non-ambulant DMD patients suffering from respiratory failure. The aim of this clinical trial will be to assess the pharmacokinetics, safety and clinical efficacy of BIO101 (20-hydroxyecdysone) in this indication. **** 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) and the ADSs (American Depositary Shares) are listed on OTC market (Ticker: BPTSY - ISIN: US09076G4010). For more information, visit 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 ( ) 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

Orphan DrugPhase 2

10 Jun 2024

·www.biospace.com

Biophytis Announces Filing of an IND Application with the US FDA for its Phase 2 Study in Obesity

PARIS, FRANCE and CAMBRIDGE, MA / ACCESSWIRE / June 10, 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, today announces that it has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) regarding its phase 2 OBA clinical study in obesity with BIO101 (20-hydroxyecdysone). The OBA study will assess the efficacy and safety of BIO101 (20-hydroxyecdysone) in patients with obesity and overweight patients with secondary comorbidities, treated for 21 weeks with GLP-1 receptor agonists (GLP-1 RAs) and undergoing hypocaloric dieting. The primary objective of the study is to assess improvements in muscle strength of lower limbs as measured by knee extension. Multiple secondary endpoints will also be explored such as mobility (as measured by the 6-minute walk test) and body composition (fat mass, lean body mass). This placebo-controlled multicenter international study is expected to start mid-2024, following regulatory approval to be received from the FDA no sooner than 30 days after the filing, with first patients expected to be treated in the second half of 2024. Biophytis is also actively engaging in the process to broaden its research capacity by including European clinical centers. First results of the efficacy of BIO101 (20-hydroxyecdysone) are expected in 2025. The principal investigator will be Professor Marc-André Cornier, Professor of Medicine and Director of the Division of Endocrinology, Diabetes and Metabolic Diseases at the Medical University of South Carolina. He is a worldwide recognized medical expert in the field of obesity and is currently President-Elect of the US-based Obesity Society. Professor Cornier has joined Biophytis' Scientific Advisory Board for the OBA project, already composed of Professor Dennis Villareal and Professor Francisco Guarner. Stanislas Veillet, CEO of Biophytis, stated: "More than 15 million adults in the US will be treated with anti-obesity medications by 2030, representing 13% penetration into the US adult population and an estimated addressable market size of $100 billion. It is crucial for Biophytis to position itself on this gigantic medical challenge which also presents great potential revenue. The filing of the Investigational New Drug application shows our commitment to accelerate our development in this indication and should be attractive to potential pharma partners." Professor Cornier is currently Professor of Medicine and Director of the Division of Endocrinology, Diabetes and Metabolic Diseases at the Medical University of South Carolina. Prior to that he was on faculty at the University of Colorado with the Division of Endocrinology, Metabolism and Diabetes until 2021. At the University of Colorado, Dr. Cornier was the Associated Division Head for Endocrinology as well as the Associate Director and Medical Director of the University of Colorado Anschutz Health and Wellness Center. Dr. Cornier was also on staff at Denver Health Medical Center in Denver, Colorado from 1999 to 2016 as a general clinical endocrinologist and at Aspen Valley Hospital in Aspen, Colorado from 2017 to 2021. Dr. Cornier is an active clinical and translational investigator with a primary research interest in understanding the complex regulation of food intake and body weight and in studying optimal interventions for weight management and metabolic health. He has also been involved in clinical trials for investigational treatments for lipid disorders and obesity. Dr. Cornier has been an active volunteer in important health-related associations, such as the Endocrine Society, American Diabetes Association, American Heart Association, National Lipid Association, and The Obesity Society. **** 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) and the ADSs (American Depositary Shares) are listed on OTC market (Ticker: BPTSY - ISIN: US09076G4010). For more information, visit 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 ( ) 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

Phase 2Executive Change

100 Deals associated with Ruvembri

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
SARS-CoV-2 acute respiratory disease	Phase 3	BR	Biophytis SA	28 Aug 2021
COVID-19	Phase 3	FR	Intsel Chimos SA	-
Gait Disorders, Neurologic	Phase 2	US	Biophytis SA	24 May 2018
Gait Disorders, Neurologic	Phase 2	BE	Biophytis SA	24 May 2018
Mobility Limitation	Phase 2	US	Biophytis SA	24 May 2018
Mobility Limitation	Phase 2	BE	Biophytis SA	24 May 2018
Muscle Weakness	Phase 2	US	Biophytis SA	24 May 2018
Muscle Weakness	Phase 2	BE	Biophytis SA	24 May 2018
Obesity	Phase 2	US	Biophytis SA	24 May 2018
Obesity	Phase 2	BE	Biophytis SA	24 May 2018

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


SARA-INT, COVA (MDA2024)	Phase 2/3	Muscular Dystrophy, Duchenne	-	BIO101 350 mg bid	kzkxwovmbx(vjklpmvnqz) = bfwxxadlwc fpjprnjlfa (gtcormzxvx )	Positive	03 Mar 2024
NCT04472728 (COVA, Accesswire) Manual	Phase 2/3	COVID-19	233	BIO-101	fhheuwctnc(ahducelvdb) = uidtvpkzro bxuddcltdu (iduztebaiy ) View more	Positive	07 Sep 2022
NCT04472728 (COVA, Accesswire) Manual	Phase 2/3	COVID-19	233	Placebo	fhheuwctnc(ahducelvdb) = nbgxqurpij bxuddcltdu (iduztebaiy ) View more	Positive	07 Sep 2022

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis