BioXcel Therapeutics provides clinical and business update
- Patient enrollment is progressing in the SERENITY At-Home Phase 3 trial of BXCL501 for agitation in bipolar disorders and schizophrenia.
- Plans are developed for the TRANQUILITY In-Care Phase 3 trial of BXCL501 for agitation associated with Alzheimer's dementia.
- The company has enhanced operational and financial flexibility through a credit amendment and raised $7 million in equity funding.
- Strategic leadership has been strengthened with recent Board appointments.
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Algernon NeuroScience appoints Validcare as CRO for Phase 2a DMT stroke trial
- Algernon NeuroScience has selected Validcare as the CRO for its Phase 2a DMT study involving 40 stroke patients in Europe.
- The study is a randomized, double-blind, placebo-controlled trial set to begin patient enrollment in Q3 2025.
- Validcare has also invested USD $170K in Algernon NeuroScience, with the investment to be completed in stages.
- The trial aims to explore DMT's potential in reducing ischemic stroke damage and promoting neuroplasticity.
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Shionogi and Jordan’s Guardian Angels announce first-ever human drug study for Jordan’s Syndrome
- Shionogi and Jordan’s Guardian Angels have launched a Phase 2 clinical trial for Jordan's Syndrome, an ultra-rare genetic disorder.
- The trial will evaluate the safety and tolerability of zatolmilast, a selective PDE4D inhibitor, in 30 participants aged 9-45 years.
- Participants will undergo a 24-week double-blind period followed by a 24-week open-label extension.
- The study is expected to conclude in late 2026, with the FDA granting Rare Pediatric Disease Designation for zatolmilast.
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SiteOne Therapeutics announces positive phase 1 clinical data for STC-004
- SiteOne Therapeutics reported positive phase 1 results for STC-004, a NaV1.8 inhibitor for non-opioid pain treatment.
- The trial assessed safety, tolerability, and pharmacokinetics in single and multiple ascending dose arms.
- STC-004 showed rapid absorption, low variability, and was well-tolerated at all doses.
- The company plans to advance STC-004 into phase 2 trials in the second half of the year.
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