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-BE

/ Not yet recruitingPhase 2

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 Date18 May 2020

Sponsor / Collaborator-

EUCTR2019-004602-94-BE

/ Unknown statusPhase 1

A 3-part, Randomized, Double Blind, Adaptive Seamless Phase 1-3 Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of BIO101 in Non-Ambulatory Patients with a Genetically Confirmed Diagnosis of Duchenne Muscular Dystrophy and Evidence of Respiratory Deterioration - Adaptive Seamless Phase 1-3 Study of Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of BIO

Start Date27 Mar 2020

Sponsor / Collaborator

Biophytis SA

100 Clinical Results associated with Ruvembri

100 Translational Medicine associated with Ruvembri

100 Patents (Medical) associated with Ruvembri

5,750

Literatures (Medical) associated with Ruvembri

01 May 2025·NAUNYN-SCHMIEDEBERGS ARCHIVES OF PHARMACOLOGY

Pyroptosis was suppressed by 20-hydroxyecdysone through Lin28b-mediated let-7d in vascular endothelial cells

Article

Author: Yang, Jianjun ; Chen, Danli ; Song, Qiang ; Jin, Zhen ; Zheng, Zihan ; He, Jianyu ; Ren, Lingxuan ; Ding, Rongcheng ; Wang, Jianjiang ; Lin, Rong ; Wen, Jiazheng

20-hydroxyecdysone (20E), a natural polyhydroxylated steroid, has exhibited anti-inflammatory effects across various diseases. This study investigates the potential connection between 20E's anti-inflammatory properties and the RNA-binding protein Lin28b, which is notably upregulated in TNF-α-stimulated endothelial cells. Herein, we discovered that 20E can selectively downregulate Lin28b expression without affecting its paralog Lin28a. Notably, 20E treatment could significantly attenuate pyroptosis, an inflammatory form of programmed cell death, as evidenced by reduced IL-1β and LDH release, and fewer propidium iodide (PI)-positive cells. Subsequent protein analysis revealed that 20E inhibited the enhanced expressions of key pyroptosis-associated proteins, GSDMD, GSDMD-N, and GSDME-N. Besides, this suppression of Lin28b and pyroptosis may be partially mediated through TNFR1. Additionally, 20E upregulated let-7 miRNA, particularly let-7d, a critical downstream target of Lin28b. To elucidate the role of Lin28b in 20E-mediated pyroptosis attenuation, we performed Lin28b overexpression and silencing experiments. Overexpressing Lin28b negated 20E's inhibition of LDH release and PI-related fluorescence, exacerbating GSDMD and GSDME cleavage. Conversely, Lin28b knockdown augmented the suppressive effect of 20E on pyroptosis, which was reversed by a let-7d inhibitor. Co-transfection with let-7d mimic and Lin28b plasmid demonstrated let-7d's role in mitigating pyroptosis aggravated by Lin28b overexpression. Overall, this study demonstrates that 20E may mitigate GSDMD and GSDME-mediated pyroptosis in HUVECs through the Lin28b/let-7d-dependent signaling pathway. These results highlight the potential of 20E as a promising inhibitor of pyroptosis, offering new insights into its anti-inflammatory mechanisms.

01 May 2025·INDUSTRIAL CROPS AND PRODUCTS

Latent effect of Achillea fragrantissima on Culex pipiens and molecular docking analysis of mosquito selected reproductive enzyme

Author: Alatawi, Hanan Ali

Mosquitoes still the main vector for many diseases all over the world.Plants consider a rich source for many biocidal compounds can be used alternative to chem. insecticides.In this study the ethanolic extract of Achillea fragrantissima has promising acute and chronic effect as larvicidal agent against Culex pipiens.The LC50 and LC95 were 108.24 & 521.21 ppm resp.The fecundity and fertility of adult female rose from sub-lethal treatment larvae also affected significantly in comparison with control group.Docking investigations were performed for 3,3',4'-trimethoxyflavone, Arginine, and N-alpha-acetyl-L-ornithine compounds against 20-hydroxyecdysone (PDB ID: 2R40).The docked compounds' docking energy score for 3,3',4'-trimethoxyflavone, Arginine, and N-alpha-acetyl-L-ornithine with the enzyme (PDB ID: 2R40) receptor were found to be -5.58, -5.11, and -4.84 kcal/mol, which are greater than the co-crystallized control ligand or nearly.These results are in line with the ethanolic extract of Achillea fragrantissima demonstrated bioactivity against Culex pipiens in experimentsThe impact of ethanolic extract of Achillea fragrantissima on reproductive potency was confirmed by mol. docking.

01 May 2025·INSECT BIOCHEMISTRY AND MOLECULAR BIOLOGY

Functional analysis of the epsilon glutathione S-transferases in the adaptation of Spodoptera litura to xanthotoxin

Article

Author: Xiao, Tianxiang ; Xu, Xiyue ; Li, Jun ; Huang, Xiaodan ; He, Ziyu ; Sun, Zhongxiang ; Lu, Kai ; Deng, Mengqing ; Pan, Bo ; Zhao, Xinyu ; Jiang, Yingjie ; Wang, Wenxiu ; Yang, Zhiming

Through long-term coevolution with host plants, insects have evolved sophisticated detoxification systems to counteract plant secondary metabolites (PSMs). However, the precise mechanisms underlying these adaptations remain incompletely characterized. Our previous research identified epsilon glutathione S-transferases (GSTes) as critical mediators of xanthotoxin adaptation in Spodoptera litura, a model linear furanocoumarin. This study reveals that heterologous overexpression of five xanthotoxin-responsive GSTes in Escherichia coli significantly enhances bacterial tolerance to this PSM. Disk diffusion assays and metabolic studies demonstrated that both GSTe1 and GSTe16 mediate xanthotoxin adaptation via dual mechanisms involving antioxidant activity and catalytic metabolism. Fluorescent competitive binding experiments indicated that all five GSTes exhibit non-catalytic xanthotoxin sequestration capabilities. These in vitro observations were complemented by in vivo genetic manipulation of GSTe16, which exhibited the most potent defense activity against xanthotoxin. CRISPR/Cas9-mediated GSTe16 knockout in S. litura significantly increased larval susceptibility to xanthotoxin, while transgenic Drosophila melanogaster overexpressing GSTe16 showed enhanced tolerance to xanthotoxin. Furthermore, the endogenous biosynthesis of 20-hydroxyecdysone (20E) was provoked upon exposure to xanthotoxin, and 20E application enhanced the larval tolerance to xanthotoxin as well as the expression levels of GSTe16. Dual-luciferase reporter assays identified two functional cis-regulatory elements in the GSTe16 promoter that facilitate transcriptional activation by the ecdysone receptor (EcR)/ultraspiracle (USP) heterodimer. Overall, this study elucidates the biochemical defense characteristics and transcriptional responses of GSTes to xanthotoxin in S. litura, providing novel insights into the counter-defense mechanisms of herbivorous insects against host plants.

105

News (Medical) associated with Ruvembri

30 Sep 2024

·www.biospace.com

Biophytis Publishes First-Half Financial Results and Provides an Update on its Business Activities

PARIS, FRANCE and CAMBRIDGE, MA / ACCESSWIRE / September 30, 2024 / Biophytis SA (Euronext Growth Paris:ALBPS) (“Biophytis” or the “Company”), a clinical-stage biotechnology company focused on developing treatments for age-related diseases, publishes today its financial results for the first half of 2024 and provides an update on the company’s key achievements. Stanislas Veillet, CEO of Biophytis , commented: “We are particularly pleased with the progress made in the first half of 2024. The launch of our clinical program OBA for obesity, addressing a major public health issue, and our partnership with Blanver to develop BIO101 in Latin America, are key milestones that demonstrate Biophytis’ ability to innovate and capitalize on market opportunities. We are now entering a critical phase where the results of our clinical trials, especially in the obesity field, along with our continued strategy of regional pharmaceutical partnerships, particularly in Asia, could significantly transform the company’s future. Despite the ongoing challenges in financial markets, the Company has been able to extend its bond financing line, and is actively working on recapitalization solutions to support its future growth.” Key Highlights for the First Half of 2024: Launch of a new obesity program with BIO101 (20-hydroxyecdysone ): In April 2024, Biophytis announced the launch of its OBA program targeting obesity with BIO101 (20-hydroxyecdysone). The global market for obesity treatments, valued at $6 billion in 2023, is projected to reach $100 billion by 2030, with an average annual growth rate of 42%. Biophytis is positioned to capitalize on this trend with BIO101, the first oral MAS receptor activator, already recognized for its beneficial effects on muscle mass and fat mass regulation in preclinical models. A phase 2 clinical trial for the OBA program, involving 164 patients with obesity, is set to begin in the second half of 2024. Results from this pivotal study are expected by the end of 2025 and could pave the way for new therapeutic options for millions of patients struggling with obesity. Exclusive Licensing Agreement with Blanver for Latin America: In June 2024, Biophytis entered into an exclusive licensing agreement with Blanver, a leading pharmaceutical player in Latin America, for the registration and commercialization of BIO101 across all its current indications: sarcopenia, obesity, COVID-19, and Duchenne muscular dystrophy. This strategic partnership could generate up to €108 million in revenue for Biophytis through milestone payments and sales-based royalties. The first phase of the agreement involves regulatory submissions in several key Latin American countries at the beginning of 2025. Expansion of Financing Capabilities: During the first half of 2024, Biophytis leveraged its bond financing line with Atlas through a new issuance of €4 million. The contract, set to expire in June 2024, was renewed for two years with a total value of €16 million, allowing the Company to draw €2 million every 40 trading days. This amendment provides the Company with a bond financing facility, complementing equity financing or non-dilutive funding options. Financial highlights: 06/30/2023 06/30/2024 (amounts in thousands of euros, except share data) 6 months 6 months Research and development costs, net (3,763 ) (2,105 ) General and administrative expenses (2,761 ) (2,285 ) Operating income (6,524 ) (4,390 ) Financial expenses (795 ) (1,545 ) Financial income 143 121 Change in fair value of convertible bonds (589 ) (3 ) Net financial income (1,240 ) (1,427 ) Profit before tax (7,764 ) (5,817 ) Income tax - - Net income (loss) (7,764 ) (5,817 ) Biophytis’ operating result shows a loss of €4.4 million as of June 30, 2024, compared to €6.5 million a year earlier. External expenses have significantly decreased, particularly in R&D activities. This change is explained by the completion of clinical trials for the COVA and SARA programs in the first half of 2023, along with substantial internalization of regulatory and clinical work associated with the launch of the OBA obesity program initiated in April 2024, as well as a global reduction in overhead expenses. The financial result decreased from -€1.2 million as of June 30, 2023, to -€1.4 million as of June 30, 2024, mainly driven by expenses related to convertible and non-convertible bond borrowings with Atlas Capital and Blackrock (formerly Kreos Capital). The net loss amounts to €5.7 million as of June 30, 2024, compared to €7.8 million for the same period in 2023. The company’s available cash stood at €2.2 million as of June 30, 2024, compared to €5.6 million as of December 31, 2023. These resources, which include non-dilutive financing obtained during the summer totaling €0.8 million (including Bpifrance subsidies and partial pre-financing of the 2024 CIR), are expected to fund operations until the end of October 2024. Drawing a new €2 million tranche from the bond facility with Atlas Capital could extend the cash horizon until the end of 2024. This drawdown is conditional upon the outstanding debt with Atlas, which must not exceed €2 million at the time of the drawdown. It is noted that the current outstanding debt is €2.3 million. Outlook and Next Steps The Company will continue in 2024 and 2025 with its value creation strategy focused on the development of its therapeutic innovations. Based on its financing capabilities, the Company plans to advance its drug candidate BIO101 (20-hydroxyecdysone) through proof of concept in humans, demonstrating tolerance and efficacy in a phase 2 study across two indications: obesity and Duchenne muscular dystrophy. For its sarcopenia and severe COVID-19 programs with BIO101, the Company will actively seek co-development partnerships based on the positive results already achieved in terms of efficacy and safety. OBA Program - Development of BIO101 for Obesity The Company plans to initiate the Phase 2 OBA study in the second half of 2024, in the United States, with potential additional centers in Europe. Preliminary results on the efficacy of BIO101 are expected by the end of 2025. MYODA - Development of BIO101 for Duchenne Muscular Dystrophy (DMD) The Company plans to start a phase 1/2 OBA study in non-ambulant DMD patients in 2025. SARA (development of BIO101 in sarcopenia) and COVA (development of BIO101 in severe forms of COVID-19) programs Over the past few years, the Company has achieved significant results in terms of efficacy, particularly in patients with sarcopenia and severe forms of COVID-19, while demonstrating good tolerance in these fragile patients. The next development steps for the SARA and COVA programs will require long and costly Phase 3 studies, for which the support of a pharmaceutical partner will be necessary through co-development and licensing agreements. Following the agreement with Blanver in June 2024 for Latin America, Biophytis is now focusing its search for potential partners in the Asia region. Sarcopenia is a widespread condition in this region, particularly in China and Japan. In these two countries, nearly 38 million people over the age of 65 suffer from sarcopenia 1 , and this population is expected to grow by over 5% per year through 2030 2 , making it an especially attractive target market. Upcoming events: October 2, 2024: European Midcap Event - Paris December 6-8, 2024: International Conference on Sarcopenia, Cachexia, and Wasting Disorders (SCWD International Conference) - Washington DC, USA About BIOPHYTIS Biophytis SA is a clinical-stage biotechnology company focused on developing drug candidates for age-related diseases. BIO101 (20-hydroxyecdysone), our lead drug candidate, is a small molecule in development for muscular diseases (sarcopenia, Phase 3 ready to start, and Duchenne muscular dystrophy, Phase 1-2 to be started), respiratory diseases (COVID-19, Phase 2-3 completed), and metabolic disorders (obesity, Phase 2 to be started). The company is headquartered in Paris, France, with subsidiaries in Cambridge, Massachusetts, USA, and Brazil. The Company’s ordinary shares are listed on Euronext Growth Paris (ALBPS - FR001400OLP5) and its ADS (American Depositary Shares) are listed on the OTC market (BPTSY - US 09076G401). For more information, visit . Disclaimer 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 comparable words. These forward-looking statements are based on assumptions that Biophytis considers reasonable. However, there is no guarantee that the forward-looking statements contained in these statements will be accurate, as they 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 significant by Biophytis. Therefore, there are or will be important factors that could cause actual results to differ materially from those indicated in these statements. Please also refer to the “Risks and Uncertainties” section of the Company’s 2023 annual financial report available on the BIOPHYTIS website ( ), and as outlined in the “Risk Factors” section of Form 20-F and other forms filed with the SEC (Securities and Exchange Commission, USA). We do not undertake to publicly update or revise forward-looking statements, whether as a result of new information, future developments, or otherwise, unless required by law. Biophytis Contacts Investor Relations Nicolas Fellmann, Chief Financial Officer Investors@biophytis.com Media Contacts Antoine Denry: antoine.denry@taddeo.fr - +33 6 18 07 83 27 Nizar Berrada: nizar.berrada@taddeo.fr - +33 6 38 31 90 50 Consolidated financial statement 12/31/2023 06/30/2024 (amounts in thousands of euros) ASSETS Patents and software 2,637 2,535 Property, plant and equipment 315 275 Property, plant and equipment - right of use 186 160 Other non-current financial assets 158 161 Total non-current assets 3,110 2,970 Other receivables 2,916 3,442 Other current financial assets 368 113 Cash and cash equivalents 5,567 2189 Total current assets 8,850 5,744 TOTAL ASSETS 11,960 8,714 LIABILITIES Capital 2,081 4,203 Additional paid-in capital 13,483 14,062 Own shares (12 ) (9 ) Conversion differences (25 ) (58 ) Reserves - Group share (2,357 ) (18,771 ) Net income - Group share (17,026 ) (5,812 ) Shareholder equity - Group share (3,857 ) (6,385 ) Non-controlling interests (32 ) (33 ) Total shareholder equity (3,889 ) (6,418 ) Staff commitments 237 224 Non-current borrowing 3,247 818 Total non-current liabilities 3,484 1,041 Current borrowings 5,023 8,838 Short-term lease liabilities 54 Provision 223 179 Trade accounts payable 5,392 3,758 Tax and social security liabilities 1,348 940 Current derivative liabilities 1 Other creditors and accrued liabilities 378 322 Total current liabilities 12,365 14,091 TOTAL LIABILITIES 11,960 8,714 Consolidated income statement 06/30/2023 06/30/2024 (amounts in thousands of euros, except share data) 6 months 6 months Revenues - - Cost of sales - - Gross margin - - Research and development costs, net (3,763 ) (2,105 ) General and administrative expenses (2,761 ) (2,285 ) Operating income (6,524 ) (4,390 ) Financial expenses (795 ) (1,545 ) Financial income 143 121 Change in fair value of convertible bonds (589 ) (3 ) Net financial income (1,240 ) (1,427 ) Profit before tax (7,764 ) (5,817 ) Income tax - - Net income (loss) (7,764 ) (5,817 ) Of which Group share (7,764) (5,812) Of which non-controlling interests - (5 ) Weighted average number of shares outstanding (excluding treasury shares) 818,873 3,499,971 Basic earnings per share (€/share) (9.48 ) (1.66 ) Diluted earnings per share (€/share) (9.48 ) (1.66 ) Note: for comparison purposes, the number of shares used to calculate earnings per share as of 06/30/2023 retrospectively takes into account the reverse stock-split of May 3, 2024 on the basis of one new share for 400 old shares Statement of consolidated comprehensive income 06/30/2023 06/30/2023 6 months 6 months (amounts in thousands of euros) Net income (loss) (7,764 ) (5,817 ) Items not recyclable in the income statement Actuarial gains and losses on post-employment benefits 23 10 Items recyclable in the income statement Conversion difference variation 18 10 Other comprehensive income items 41 20 Comprehensive income (loss) (7,724 ) (5,797 ) Of which Group share (7,724) (5,796) Of which non-controlling interests - (1) Statement of consolidated cash flows 06/30/2023 06/30/2024 (amounts in thousands of euros) 6 months 6 months Cash flow from operating activities Net income (loss) (7,764 ) (5,817 ) Elimination of depreciation on fixed assets 256 148 Provisions, net of reversals (200 ) (64 ) Share-based payment costs 322 515 Gross interest paid 549 547 Change in fair value of convertible bonds 589 236 Discounting / undiscounting advances 12 Amortized cost of convertible and non-convertible bonds 149 Other items without cash impact 760 Cash flow from operating activities before changes in working capital (6,086 ) (3,674 ) (+) Change in working capital (net of impairment of trade receivables and inventories) (2,075 ) (2,278 ) (Increase) decrease in other non-current financial assets 9 (Increase) decrease in other receivables 2,018 122 (3,230 ) (1,574 ) Increase (decrease) in tax and social security liabilities (876 ) (735 ) 4 (91 ) Cash flow from operating activities (8,204 ) (5,951 ) Cash flow related to investment operations Acquisition of intangible assets and property, plant and equipment (90 ) (9 ) Subscription of term deposits classified as other current financial assets (695 ) Decrease (increase) in term deposits classified as other non-current financial assets 8 Cash flow related to investment operations (177 ) (9 ) Cash flow related to financing operations Capital increase 2,303 - Expenses relating to capital increase (339 ) - Exercise of ‘BSA’ warrants and ‘BSPCE’ warrants - 9 Receipt of grants - - Payment of CIR (Research tax credit) pre-financing net of deposit 1,059 164 Payment of repayable advances - Repayment of repayable advances (165 ) (110 ) Gross interest paid (246 ) (547 ) Issue of convertible and non-convertible bonds 1,890 4,000 Repayments of convertible and non-convertible bonds (615 ) (680 ) Repayment of lease liabilities (144 ) (26 ) Bond issue costs (55 ) (220 ) Other cash flows related to financing operations (8 ) Cash flow related to financing operations 3,691 2,582 Impact of exchange rate fluctuations (24 ) Increase (decrease) in cash flow (5,272 ) (3,378 ) Opening cash and cash equivalents 11,053 5,567 End of year cash and cash equivalents 5,782 2,189 1 Yuan 2023, Epidemiology of Sarcopenia, Metabolism; Shafiee 2017, Prevalence of Sarcopenia in the world, Journal of diabetes & metabolic disorders; 2 Marché du traitement de la sarcopénie - Analyse des tendances et de la croissance | Année de prévision 2030 - - SOURCE: Biophytis

License out/inPhase 2Financial StatementPhase 3

11 Jul 2024

·www.biospace.com

Biophytis Obtains IND Approval from the FDA to Start its Phase 2 OBA Study in Obesity

PARIS, FRANCE AND CAMBRIDGE, MA / ACCESSWIRE / July 11, 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 announced that it has received Investigational New Drug (IND) approval from the Food and Drug Administration (FDA) for its phase 2 OBA clinical study in obesity with BIO101 (20-hydroxyecdysone). The primary objective of the study is to measure the improvement in muscle strength in the lower limbs, as assessed by knee extension test. Secondary endpoints will include analysis of mobility (via the 6-minute walk test) and body composition (assessment of fat and lean mass). A world-renowned medical expert in the field of obesity and President-elect of the American Obesity Society, Marc-André Cornier, Professor of Medicine and Director of the Endocrinology, Diabetes and Metabolic Diseases Unit at the Medical University of South Carolina, will be the principal investigator of the phase 2 OBA study. Professor Marc-André Cornier commented: "I am very happy that the IND for the phase 2 OBA clinical study with BIO101 (20-hydroxyecdysone) has been approved by the FDA. It is critical for us to study the safety and efficacy of new therapies designed to reduce the risk of muscle mass loss and resulting muscle weakness with functional consequences that may be associated with incretin-based therapies. Additionally we might observe further weight loss over and above that obtainable with a GLP-1 RA." The multicenter study is due to start mid-2024 in the USA and could be extended to Europe. Preliminary results on the efficacy of BIO101 (20-hydroxyecdysone) are expected in 2025. Biophytis is seeking funding and partnerships to complete this study. Stanislas Veillet, CEO de Biophytis, stated: "Obesity represents a major medical challenge and a significant growth opportunity for Biophytis. The obesity treatment market, estimated at $6 billion in 2023, is expected to reach $100 billion by 2030, with an average annual growth rate of 42%. Obtaining an IND from the FDA is a crucial step that will enable us to make rapid progress in this indication and attract new pharmaceutical partners. We are convinced that BIO101 could become a reference treatment for preserving muscle mass, strength and function in obese patients treated with GLP-1 RAs. This development has convinced our partner Blanver in Latin America, and we are convinced that it will attract new ones in other regions of the world where obesity is a major health issue." **** 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, phase 1-2 study to be started, respiratory (Covid-19, phase 2 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 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 2IND

01 Jul 2024

·www.biospace.com

Biophytis Presented its Phase 2-3 COVA Study Results in Severe Forms of Covid-19 at the WCID in Paris

PARIS, FRANCE AND CAMBRIDGE, MA / ACCESSWIRE / July 1, 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, presented the roll-out and results of its phase 2/3 COVA study in the treatment of severe forms of Covid-19 at the 6th edition of the World Congress on Infectious Diseases, held from June 24 to 26, 2024 in Paris, France. Professor Valerie Pourcher MD, PhD, Chaiman of the Infectious Diseases department at Pitié Salpetriere, presented the COVAphase 2/3 clincial study results in a context where the number of Covid cases rises again. Dr. Claudia Ferreira MD, PhD, Medical Director at Biophytis, opened the conference with a keynote presentation on the risk of infectious diseases and further pandemic developments associated with the Paris Olympic games including an increase of +52 %in emergency room (ER) visits due to SARS-CoV-2 on the week of 10-17 June 2024 in France. She also chaired several roundtables. Valerie Pourcher detailed the results of the randomised, placebo-controlled Phase 2/3 COVA study and the efficacy of oral BIO101 (20-hydroxyecdysone) administered orally in adult patients hospitalised for severe forms of COVID-19. The results of this phase 2-3 study, evaluating BIO101 in the treatment of severe hospitalised COVID-19 patients, are positive and show, in addition to a very good safety profile, a statistically significant reduction in the relative risk of early respiratory failure or death of 43.8% and a 44.6% reduction in the death rate over 90 days. Stanislas Veillet, CEO of Biophytis, stated: "The Covid pandemic is far from over: according to the World Health Organization, 134,797 new cases of Covid-19 and 1,691 deaths have been reported worldwide in the last 28 days as of June 9 - a figure that is underestimated due to under-reporting. Our COVA program, which showed very positive resullts, positions BIO101 (20-hydroxyecdysone) as a leading drug candidate for severe forms of Covid-19, particularly in elderly patients with co-morbidities, that is independent of the SARS-COV2 strain." The poster presented at the Congress, which details the objectives, the design and the results of the study, can be viewed by clicking on this link. **** 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 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

Clinical ResultPhase 3Phase 2

100 Deals associated with Ruvembri

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
COVID-19	Phase 3	United States	Biophytis SA	26 Aug 2020
COVID-19	Phase 3	Belgium	Biophytis SA	26 Aug 2020
COVID-19	Phase 3	Brazil	Biophytis SA	26 Aug 2020
COVID-19	Phase 3	France	Biophytis SA	26 Aug 2020
COVID-19	Phase 3	Puerto Rico	Biophytis SA	26 Aug 2020
Gait Disorders, Neurologic	Phase 2	United States	Biophytis SA	07 Feb 2017
Gait Disorders, Neurologic	Phase 2	Belgium	Biophytis SA	07 Feb 2017
Mobility Limitation	Phase 2	United States	Biophytis SA	07 Feb 2017
Mobility Limitation	Phase 2	Belgium	Biophytis SA	07 Feb 2017
Muscle Weakness	Phase 2	United States	Biophytis SA	07 Feb 2017

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03452488 (SARA-INT, CTgov)	Phase 2	Gait Disorders, Neurologic \| Obesity \| Mobility Limitation ... View more	233	Placebo (Placebo)	joydacuqyy(vuumapsezk) = kbgazebzhj ommpztioxf (jhkwpzpbih, xsvkrxvpni - tbppvilwwb) View more	-	01 Oct 2024
NCT03452488 (SARA-INT, CTgov)	Phase 2		233	BIO101 (175mg BIO101)	joydacuqyy(vuumapsezk) = njowtgvlpi ommpztioxf (jhkwpzpbih, tasiownnyl - nxiuqmwkmg) View more	-	01 Oct 2024
NCT04472728 (Biospace) Manual	Phase 2/3	COVID-19	-	BIO101 (20-hydroxyecdysone)	wqaqjmkhor(snosfkvqvh) = eqwbmlzyed nzwnaguavz (sohturzkyq ) View more	Positive	01 Jul 2024
NCT04472728 (SARA-INT \| COVA, MDA2024)	Phase 2/3	Muscular Dystrophy, Duchenne	-	BIO101 350 mg bid	zompoyqmhq(sdnghuzdsw) = veinxxbhqy gnyhyylfao (ydbsyfvisx )	Positive	03 Mar 2024
NCT04472728 (COVA, Accesswire) Manual	Phase 2/3	COVID-19	233	BIO-101	lcfrdoxwgt(lzbghugktq) = tzpngkxcqo xmehlwitcd (jgeulvqliu ) View more	Positive	07 Sep 2022
NCT04472728 (COVA, Accesswire) Manual	Phase 2/3	COVID-19	233	Placebo	lcfrdoxwgt(lzbghugktq) = pndkhdrkjm xmehlwitcd (jgeulvqliu ) 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

Chat with Hiro

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. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis

Ruvembri

Overview

Basic Info

Structure/Sequence

Related

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation