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- Ocugen's OCU410ST gene therapy has received FDA approval to launch a Phase 2/3 pivotal confirmatory trial for treating all forms of Stargardt disease, with the potential to serve as the foundation for a biologics license application. - SpliceBio has administered the first dose in its Phase 1/2 ASTRA clinical trial evaluating SB-007, a dual AAV vector-based gene therapy for Stargardt disease, marking another significant milestone in gene therapy development. - Alkeus Pharmaceuticals reported positive interim results from its TEASE-3 study, showing that early-stage Stargardt disease patients receiving oral gildeuretinol acetate exhibited no disease progression and maintained stable visual acuity over multiple years. - The Stargardt disease pipeline now includes over 20 companies developing more than 20 treatment therapies, with emerging therapies like MCO-010, Tinlarebant, and others expected to significantly impact the market.
• The sarcopenia market remains largely untapped with no approved drug therapies in major markets, despite significant unmet medical needs in an aging global population. • DelveInsight reports 18+ pharmaceutical companies actively developing 20+ pipeline drugs for sarcopenia, with promising candidates including Biophytis' BIO101, TNF Pharmaceuticals' MYMD-1, and Epirium Bio's MF-300. • Recent regulatory milestones include Fast Track Designation for Lipocine's LPCN1148 for sarcopenia in patients with decompensated cirrhosis, signaling increased recognition of sarcopenia as a distinct clinical condition.
- New preclinical data shows that combining BIO101 with GLP-1 receptor agonists significantly improved mobility and grip strength in diet-induced obese mice, addressing a critical gap in obesity treatment. - The combination therapy compensates for muscle contractility alterations induced by GLP-1 alone, potentially offering a solution for the 96% of obesity patients who experience muscle strength decline. - Biophytis is advancing BIO101 to Phase 2 clinical trials for obesity, building on previous positive results from SARA-INT and Quinolia studies that demonstrated improved muscle function in human subjects.
Novavax initiates a new clinical trial to evaluate the safety and immunogenicity of its JN.1 subvariant vaccine (NVX CoV2705) with Matrix-M adjuvant. The study will compare results with the previously authorized NVX-CoV2601 vaccine, marking a significant step in addressing emerging COVID-19 variants.
- Biophytis presented its OBA program featuring BIO101 (20-hydroxyecdysone) at the 17th SCWD International Congress, highlighting its potential to mitigate muscle loss induced by GLP-1RA therapies in obese patients. - Clinical data from the Quinolia study demonstrated that 20-hydroxyecdysone reduced fat mass and maintained muscle strength in overweight and obese individuals on a hypocaloric diet. - A subgroup analysis from the SARA-INT study suggested BIO101 could improve muscle function in sarcopenic obese patients, showing statistically significant improvement in the 400-meter walking speed test. - Biophytis plans to initiate a Phase 2 OBA study in early 2025 to assess BIO101's efficacy and safety in obese patients undergoing treatment with GLP-1 RAs like Semaglutide or Wegovy.
- Biophytis has received FDA IND approval for a phase 2 clinical study evaluating BIO101 (20-hydroxyecdysone) in obesity patients to preserve muscle strength and function. - The study aims to address muscle mass loss associated with incretin-based therapies like GLP-1 receptor agonists, with primary endpoint measuring lower limb muscle strength improvement. - The multicenter trial will begin mid-2024 in the USA with potential European expansion, targeting a rapidly growing obesity treatment market projected to reach $100 billion by 2030.
- Biophytis presented its SARA-31 phase 3 protocol for Ruvembri (20-hydroxyecdysone) in sarcopenia treatment at the International Conference on Frailty and Sarcopenia Research. - The preceding SARA-INT phase 2 study demonstrated significant improvements in physical performance, with 0.07 m/s improvement in the 400 Meter Walking Test in the Full Analysis Set population. - The randomized, double-blind, placebo-controlled phase 3 study will include 932 subjects and has received regulatory approval to begin in Belgium and the United States. - CEO Stanislas Veillet stated that Ruvembri appears to be the most advanced drug candidate in sarcopenia indication, with the company actively seeking pharmaceutical partners for development and market access.
- Biophytis has received FDA authorization to launch SARA-31, marking the first-ever Phase 3 clinical trial specifically designed to treat sarcopenia, an age-related muscle wasting condition. - The study will evaluate Sarconeos (BIO101) in approximately 900 patients over 65 with severe sarcopenia, measuring the drug's ability to prevent major mobility disability over 12-36 months of treatment. - This regulatory milestone follows promising Phase IIb results where patients receiving the highest dose showed meaningful improvement in the 400-meter walk test, meeting the study's primary endpoint. - The authorization addresses a significant unmet medical need, as sarcopenia affects 10-16% of elderly populations globally and currently lacks effective pharmaceutical treatments.
- Biophytis has received positive regulatory opinion from Belgian authorities to conduct SARA-31, marking the first phase 3 study ever launched in sarcopenia, a condition affecting over 30 million patients worldwide. - The study will evaluate Sarconeos (BIO101) in approximately 900 patients over 65 with severe sarcopenia, testing its ability to prevent Major Mobility Disability over 12-36 months of treatment. - No drug is currently approved anywhere in the world for sarcopenia, positioning Biophytis as a pioneer in developing treatments for this age-related neuromuscular disease that leads to loss of autonomy and reduced life expectancy.
