Exxel Pharma is advancing its innovative small molecule drug candidate EX937 toward first-in-human clinical trials, targeting the significant unmet need in refractory chronic cough treatment. The company plans to initiate Phase 1/1b studies in the latter half of 2025, addressing a global market valued at $11 billion that currently lacks FDA-approved treatment options.
Novel Mechanism of Action and Development Strategy
EX937 represents a first-in-class approach to treating chronic cough through specific and peripheral inhibition of the fatty acid amide hydrolase (FAAH) enzyme. The drug's mechanism increases Anandamide levels, an endogenous signaling molecule that desensitizes overactive sensory neurons responsible for triggering cough reflexes.
"There remains a growing unmet need for the treatment of chronic cough which has a significant negative impact on overall quality of life for adults," stated Soren Mogelsvang, PhD, President and CEO of Exxel. "With the data demonstrated to date, we believe EX937 has the potential to address this unmet need and provide a safe and effective treatment option."
Clinical Trial Design and Safety Profile
The upcoming Phase 1/1b trial employs a two-part design, beginning with a single ascending dose (SAD) study followed by a multiple ascending dose (MAD) phase. The randomized, double-blind, placebo-controlled study will evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy volunteers of both genders.
Richard Paul, MD, Chief Medical Officer of Exxel, emphasized the drug's potential: "EX937 has the potential to be a significant advancement in care for patients suffering from chronic cough through inhibiting FAAH and desensitizing the overactive sensory neurons that trigger the urge to cough."
Notably, preclinical studies have demonstrated EX937's favorable safety profile, with the compound being completely excluded from the central nervous system and brain, potentially eliminating CNS-related side effects. The drug is designed for convenient once-daily oral administration.
Development Timeline and Future Applications
Key upcoming milestones include:
- Q2 2025: Completion of drug product development and specification
- Q3/4 2025: Initiation of Phase 1/1b patient enrollment and SAD cohort completion
- Q1 2026: Completion of MAD cohort and human cough challenge studies
Beyond chronic cough, EX937 shows promise for expansion into other significant indications, including:
- Peripheral neuropathic pain
- Migraine headaches
- Hyperactive bladder
The drug's development program has already completed IND-enabling studies and pre-IND meetings, positioning it for potential Fast Track Designation from regulatory authorities.
