Clear Phase 1 Trial Success for CS-1103, a Potential First-in-Class Meth and Fentanyl Overdose Treatment

Clear Scientific, Inc., a biopharmaceutical company in Cambridge, Massachusetts, has announced promising results from its First-in-Human Phase 1 clinical trial for the therapeutic CS-1103. The study, aimed at assessing the safety and tolerability of the compound, achieved its primary goal without any serious adverse events reported.

The trial involved thirty-two healthy volunteers divided into four cohorts. The study was designed as a single ascending dose, randomized, double-blinded, placebo-controlled trial to evaluate the safety, tolerability, and pharmacokinetics of CS-1103. Participants received single doses of CS-1103 via intravenous injection, and the drug was well-tolerated across all cohorts.

These Phase 1 results pave the way for Phase 2 studies, which will focus on treating methamphetamine and fentanyl overdoses. These trials are expected to commence in early 2025. Clear Scientific's CEO, Shekar Shetty, expressed confidence in the future of CS-1103, citing these results as a significant step towards accelerated registration. He also acknowledged the support from the National Institute on Drug Abuse (NIDA) of the NIH.

The United States continues to face a severe overdose crisis, with approximately 1.9 million emergency department visits and over 100,000 deaths annually due to overdoses. The CDC has highlighted that drug overdose mortality rates are at an all-time high, making overdose the leading cause of death for Americans under 50. While there are approved treatments for opioid overdoses, no treatments currently exist for stimulant overdoses or those resulting from drug combinations.

CS-1103, a first-in-class injectable small molecule sequestrant, works by binding to and inactivating toxic compounds, thereby reversing their effects and accelerating their elimination through urine. Clear Scientific aims to develop CS-1103 not only for overdose treatments but also for specific metabolic, central nervous system, and neurodegenerative disorders.

Clear Scientific, co-founded by George Whitesides of Harvard University, is a clinical-stage biopharmaceutical company dedicated to developing treatments for conditions and diseases caused by an excess of harmful substances in the body. Their innovative approach involves creating highly selective, small molecule sequestrants that can immediately bind, inactivate, and clear excess compounds.

The research behind these findings has been supported by the National Institute on Drug Abuse of the NIH, under award number U01DA053054. While the content of the research is the responsibility of the authors, it does not necessarily reflect the official views of the National Institutes of Health.

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