Cambridge, MA | Oct 2023
Clear Scientific Inc., a Cambridge MA based biopharmaceutical company, announced that the FDA has approved its Investigational New Drug (IND) application for CS-1103, the first antidote for stimulant overdose, granting the company permission to initiate its Phase 1 First-in-Human clinical trial. Overdose from the stimulants methamphetamine and cocaine alone result in over 1,000,000 emergency department visits per year, with over 60,000 deaths, costing US hospitals over $10 billion annually.
Upon injection, CS-1103, a sequestrant-based therapeutic, immediately inactivates stimulants by binding and encapsulation, rapidly reversing their toxic effects, and accelerates stimulant clearance from plasma into urine, i.e. rapid detox. Clear expects to start Phase 1 in early 2024. “We are excited to receive permission from the FDA to initiate First-in-Human safety studies with CS-1103. I want to thank the National Institute on Drug Abuse for their support in developing CS-1103 and our team and partners for their hard work in completing and submitting the IND package to the FDA. We will do everything we can to bring CS-1103 to patients so we can make a difference in addressing this critical unmet need,” said Shekar Shetty, Clear’s CEO.