Cyrano Therapeutics has reported that the Phase II FLAVOR study of CYR-064 met its primary safety endpoint in patients with persistent post-viral loss of smell (hyposmia).
The placebo-controlled, double-blind, randomised trial took place across 14 clinical locations in the US and included 151 participants.
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It recorded no serious adverse events linked to the treatment, whilst overall adverse event rates remained comparable between the candidate and placebo.
Results presented at the 72nd Annual Meeting of the American Rhinologic Society in Los Angeles, California, highlighted efficacy in participants aged under 60 years, who formed 66% of the trial population.
In this subgroup, a high dose of CYR-064 generated statistically significant gains in smell function over 24 weeks compared to placebo on two prespecified patient-reported assessments.
The 0-3 Visual Rating Scale showed an average improvement of 0.72 points with the therapy versus 0.12 points for placebo.
Furthermore, on the 0–10 Numerical Rating Scale, participants administered the high dose gained a mean 2.08 points compared with 0.68 points in the placebo cohort.
Participants receiving the high dose showed continuous olfactory improvements throughout the 24 weeks, whereas progress in the placebo arm plateaued earlier.
Among subjects under 60 presenting with severe baseline smell loss, the high dose recorded a 1.10-point mean gain on the Visual Rating Scale compared to 0.30 points for placebo.
Cyrano Therapeutics president and CEO Rick Geoffrion said: “The strength of the FLAVOR results reinforces our belief that CYR-064 has the potential to become the first approved pharmaceutical therapy for persistent post-viral smell loss and address a substantial global market with significant unmet need.
“With these positive Phase II data, we believe CYR-064 represents a valuable late-stage clinical asset with the potential to transform the treatment of smell loss associated with viral infection. We look forward to building on this momentum as we prepare to advance CYR-064 into Phase III development.”
The therapy is an intranasal theophylline spray that acts as a broad-spectrum phosphodiesterase inhibitor. It uses a patented targeted delivery system engineered to stimulate olfactory neurons.
Cyrano Therapeutics is a private, venture-backed clinical-stage regenerative medicine firm focused on treatments for taste and smell impairments.
