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Clear Scientific Awarded up to $15M from NIDA for Continued Development of Fentanyl Antidote.

Cambridge, MA | Nov 2023

Clear Scientific, a clinical-stage biopharmaceutical company, today announced an award from the National Institute on Drug Abuse (NIDA) of the NIH, with a total potential value of $15M, to support development of CS-1103, the first therapeutic that both rapidly deactivates and removes fentanyl from the body.

Fentanyl misuse is a nationwide crisis, with over 1M emergency department visits and 73,000 overdose deaths annually. There are substantial deficiencies in the current standard of care, and alarming trends in fentanyl misuse that require new and innovative therapies.

As stated by Dr. Nora Volkow, NIDA Director, “Deaths from fentanyl are increasing in spite of naloxone, and overdose requires multiple naloxone doses.[1]” Dr. Volkow emphasized that “There's been an eightfold increase in the number of illicit prescription medicines that actually contain fentanyl. And so you, for example, may want to take a prescription pill because you cannot sleep. You buy it in the black market, in the web, and it's contaminated and you overdose. …we're seeing a rise in overdose deaths in adolescents that we have never ever seen before.[2]”

The unique mechanism of action of CS-1103 enables its effectiveness across the spectrum of fentanyl use, i.e., (1) as an antidote to overdose that restores respiration without renarcotization (unlike opioid receptor antagonists), (2) as a means for rapid fentanyl detoxification before treatment with medications for opioid use disorder, and (3) as a means to reduce the level of fentanyl post-surgery.

The award, titled "A Therapeutic Agent to Lower the Level of Synthetic Opioids in the Body," is a UG3/UH3 Cooperative Agreement involving two phases. The $6M UG3 phase, for up to two years, is designed to support a project with specific milestones to be accomplished by the end of the period. The $9M UH3 phase is to provide funding for up to three additional years following successful completion of the UG3. UG3 projects that meet their milestones will be administratively considered by NIDA and prioritized for transition to the UH3 phase.

About CS-1103

CS-1103 is a novel sequestrant-based therapeutic that immediately inactivates target intoxicants by binding and encapsulation, rapidly reversing their toxic effects. CS-1103 also accelerates clearance of targets from plasma into urine, performing rapid detoxification of the patient; “Remove the Cause, Remove the Effect.” CS-1103 is currently in Phase 1 Clinical Trials.

About Clear Scientific

Clear Scientific is a Cambridge, MA-based clinical stage biopharmaceutical company pioneering novel therapies for life-threatening and debilitating conditions caused by an excess of harmful substances in the body. The founding team includes Prof. George Whitesides (Harvard University), who pioneered the development of sequestrant-based therapeutics. The company has a strong patent estate licensed from Massachusetts General Hospital and University of Maryland.

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[1] HEAL Presentation, April 2021


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