Cyrano Therapeutics has initiated a new investigator-initiated study to evaluate CYR-064, a novel nasal spray treatment targeting smell loss in Parkinson's disease (PD) patients. The trial (NCT06498687) aims to address hyposmia, a prevalent early non-motor symptom that can precede motor manifestations of PD by years or decades.
The innovative study will examine CYR-064, a theophylline-based nasal spray, in 15-20 patients with moderate to severe PD-related hyposmia. Participants will receive twice-daily treatments consisting of two sprays per nostril over a 24-week period.
Study Design and Patient Criteria
The single-arm trial implements rigorous inclusion criteria to ensure appropriate patient selection. Eligible participants must:
- Be between 19-80 years old
- Have PD-related hyposmia or anosmia for over 6 months
- Score 5 or less on the NRS-11 smell scale
- Maintain a Hoehn and Yahr scale score below 3
- Demonstrate a Montreal Cognitive Assessment score above 24
- Show normal nasal endoscopy findings
"The potential to restore the sense of smell in Parkinson's patients represents a significant step forward in addressing an often-overlooked aspect of the disease that decreases a patient's quality of life and contributes to the decline of their nutritional health," stated Rick Geoffrion, co-founder and chief executive officer at Cyrano.
Comprehensive Assessment Protocol
The study employs multiple evaluation methods to track patient progress:
- Weekly 11-point Numeric Rating Scale assessments for smell and taste
- Regular clinic visits at 2-week intervals during the first month
- Monthly evaluations at 8, 12, 16, and 24 weeks
- Sniffin' Sticks Olfactory Test TDI measurements at baseline and study conclusion
Principal investigator Dr. David Silvers of Gardens Neurology in Florida emphasized the significance of the research: "Hyposmia is a challenging and debilitating symptom for many Parkinson's patients, and innovative approaches like CYR-064 are critically needed."
Broader Development Program
CYR-064, which delivers theophylline—a compound commonly used in respiratory conditions—is simultaneously being evaluated in a separate Phase 2 trial. This larger study involves 150 patients with various causes of hyposmia and anosmia, including post-viral cases. Results from this randomized, placebo-controlled trial are expected in the second half of 2025.
The research represents a targeted approach to addressing quality of life issues in PD patients, with potential implications for early symptom management and improved patient outcomes.
