CYR-064 Phase II trial meets safety benchmark

Cyrano Therapeutics announced that its Phase II FLAVOR study of CYR‑064, an intranasal theophylline spray, met its primary safety endpoint. The double‑blind, placebo‑controlled trial enrolled 151 adults with persistent post‑viral hyposmia across 14 U.S. sites. Participants were randomly assigned to receive either the drug or a matching placebo.

Safety results and trial design

Safety data showed no serious adverse events linked to CYR‑064. Overall rates of mild and moderate adverse events were similar between the drug and placebo groups, supporting the tolerability of the therapy.

Efficacy analysis focused on the 66 % of participants younger than 60 years. In this subgroup, the high dose of CYR‑064 produced statistically significant improvements in smell function over 24 weeks, as measured by two patient‑reported scales. The 0–3 Visual Rating Scale increased by an average of 0.72 points versus 0.12 for placebo, while the 0–10 Numerical Rating Scale rose by 2.08 points compared with 0.68 for placebo.

Among participants under 60 with severe baseline loss, the high dose yielded a 1.10‑point gain on the Visual Rating Scale, contrasted with 0.30 for placebo. These results suggest a dose‑dependent benefit that continued to accrue throughout the study period, whereas placebo improvement plateaued earlier.

CEO Rick Geoffrion said the data reinforce the company’s belief that CYR‑064 could become the first approved drug for persistent post‑viral smell loss and that it has the potential to transform treatment for a substantial global market. Cyrano plans to advance CYR‑064 into Phase III development based on these encouraging results.

CYR‑064 is formulated as an intranasal spray of theophylline, a broad‑spectrum phosphodiesterase inhibitor. A patented targeted delivery system is designed to stimulate olfactory neurons, aligning with Cyrano’s focus on regenerative medicine for taste and smell impairments.