Clear Scientific, Inc., a US-based biopharmaceutical company, on Thursday announced positive top-line results from its Phase 2 trial of CS-1103, a small-molecule sequestrant that is claimed to immediately bind and inactivate fentanyl, subsequently accelerating its removal from the body into urine.

The company says that the results provide validation of CS-1103's novel mechanism of action. The trial met all endpoints, with CS-1103 accelerating the removal of fentanyl in human subjects and showing a favourable safety profile.

To reflect the real-world scenarios in which people overdose on fentanyl and are subsequently treated with naloxone, all participants received both fentanyl and naloxone, followed by either CS-1103 or placebo. Clear Scientific claims that CS-1103 accelerated fentanyl excretion into urine 25-fold vs control, significantly reducing fentanyl body burden.

The single-site, double-blind, randomised, inpatient pharmacokinetic and clearance study enrolled 16 healthy adults. A single intravenous dose of CS-1103 was well tolerated, with no serious adverse events reported, and all 16 participants completed the study.

CS-1103 is a first-in-class injectable small molecule sequestrant that binds and inactivates target compounds, rapidly reversing their effects and accelerating their clearance into urine. Clear Scientific is initially targeting methamphetamine, fentanyl and cocaine, which are present in close to 95% of all US drug related fatalities.