Clinical Trial News

Frankfurt University Hospital’s Department of Infectious Diseases is leading a study, RAPID_REVIVE, funded by the German Federal Ministry of Education and Research (BMBF), to treat post-COVID syndrome (PCS) with vidofludimus calcium. The phase 2, adaptive, randomized, placebo-controlled, and double-blind clinical trial aims to alleviate long-term COVID-19 effects like fatigue and cognitive impairment. The study, part of the German Network of University Medicine (NUM), will include 376 patients at eleven NAPKON locations and adjust treatment allocation based on interim evaluations.

Hispanic, Black, and Asian participants were underrepresented in PEDIG clinical studies (1997-2022), while White participants were overrepresented. Female participants were proportionately represented. Trends showed increasing Hispanic and decreasing White enrollment, suggesting an opportunity to improve diversity in pediatric ophthalmology studies.

Hoth Therapeutics receives IRB approval from Dana-Farber Cancer Institute and Montefiore Medical Center for Phase 2a clinical trial of HT-001 to treat skin toxicities from EGFRi.

Aelis Farma's Phase 2B trial with AEF0117 for cannabis use disorder (CUD) did not meet primary goals, including reducing cannabis use to one day or less per week. AEF0117 was well-tolerated, but Indivior, which has an option to license the drug, does not expect to exercise it due to lack of separation from placebo.

Leidos Biomed seeks a US-based CDMO for Fill & Finish services of an mRNA-LNP vaccine for a Phase 1 trial, targeting Nov-Dec 2024. Subcontractor must confirm capability to meet timeline and adhere to cGMP. Questions due by Sep 20, 2024, and proposals by Sep 27, 2024.

Moderna's updated COVID-19 mRNA vaccine, Spikevax, targeting the JN.1 variant, receives positive opinion from CHMP for authorization in EU for ages 6 months and over for autumn/winter 2024-2025 season, based on efficacy and safety data. Moderna has similar approvals in Japan, Taiwan, and the UK, and is participating in EU tender for Covid vaccines.

ProKidney is discontinuing its ex-US Phase III study for CKD cell therapy rilparencel to focus on the US market, saving $150m-$175m. The decision follows regulatory discussions and aims to expedite market entry in the US, where the therapy has RMAT designation.

CBD administration in Croatia improved daytime fatigue and psychological well-being in a five-week trial, though sleep quality was not similarly enhanced.

Mindstate Design Labs received FDA and EMA approval for human trials of MSD-001, described as 'psychedelic tofu' for its mild effects. The trials aim to validate the neurotech AI platform, Osmanthus, designed to create tailored altered states of consciousness. CEO Dillan DiNardo envisions using psychedelics as tools to understand and design specific mental states, potentially addressing conditions beyond traditional psychedelic uses.

Acadia Pharmaceuticals' COMPASS-PWS Clinical trial, enrolling PWS patients aged 5-30 with hyperphagia, aims to evaluate carbetocin's safety and efficacy via nasal spray. The phase 3 study involves 170 participants in a double-blind setup, with key eligibility criteria including no recent food interventions or treatment studies. The trial includes 5 clinic visits and an optional 3-year open-label extension. For details, visit compasspws.com.