Cyrano Therapeutics has completed enrollment in its Phase 2 FLAVOR clinical trial evaluating CYR-064, a novel treatment for post-viral smell loss (hyposmia). The randomized, double-blinded, placebo-controlled study enrolled 150 patients across 14 U.S. clinical sites, with topline data expected in the fourth quarter of 2025.
The trial represents a significant step toward developing the first FDA-approved pharmaceutical treatment for post-viral hyposmia, a condition affecting more than 60 million people across the United States, Europe, and Japan.
"Completion of enrollment in our FLAVOR trial is a significant milestone in our mission to develop the first potential pharmaceutical treatment for post-viral smell loss," said Rick Geoffrion, President and CEO of Cyrano Therapeutics. "We are deeply grateful to the patients and investigators who have contributed to this critical research."
Innovative Delivery Technology
In a parallel development, Cyrano Therapeutics recently announced an exclusive licensing agreement with Resyca for its proprietary soft mist nasal spray technology specifically for treating chemosensory disorders, including post-viral smell loss.
The soft mist technology, integrated into Ursatec's 3K® pump system, is designed to optimize drug deposition in the nasal cavity and olfactory region. The precisely controlled droplet size and low spray velocity are expected to improve drug distribution to the target olfactory region, potentially enhancing CYR-064's therapeutic efficacy.
"This agreement with Resyca enables us to enhance the efficacy of our treatment for patients experiencing chemosensory dysfunction by delivering our proprietary formulation through their advanced soft mist technology," Geoffrion explained. "Resyca's soft mist technology plays a critical role in optimizing the deposition and delivery of CYR-064 in the olfactory region to maximize its therapeutic potential."
Remko Beimers, CEO of Resyca, added, "Our patented nasal soft mist technology enables advanced drug delivery for both biologics and small molecules. Partnering with Cyrano Therapeutics aligns with our mission to drive innovation in drug delivery solutions."
Addressing an Unmet Medical Need
Post-viral hyposmia is a chronic sensory condition that significantly impairs quality of life for many sufferers. In older individuals, it is associated with an increased risk of cognitive impairment and mortality. Despite its prevalence, there are currently no FDA-approved therapies indicated for the treatment of smell loss.
CYR-064 is a patent-protected, intranasal formulation of a broad-spectrum phosphodiesterase (PDE) inhibitor designed to enhance olfactory neuron excitability and restore the sense of smell. The drug's mechanism of action targets the underlying neurological processes involved in smell perception.
Dr. Mas Takashima, Professor and Chairman of the Department of Otolaryngology – Head and Neck Surgery at Houston Methodist Hospital and the principal investigator for the FLAVOR trial, emphasized the importance of this research: "Completing enrollment in the FLAVOR trial is an important milestone in our efforts to bring forward the first potential treatment for patients suffering from post-viral hyposmia. We are eager to review the results and validate the promise of CYR-064."
Trial Design and Expectations
The Phase 2 FLAVOR trial is evaluating the safety, tolerability, and efficacy of CYR-064 compared to placebo over a six-month treatment period. The study's comprehensive design aims to provide robust data on the drug's potential to address this significant unmet medical need.
The trial's completion comes at a time of increased awareness about smell disorders, particularly following the COVID-19 pandemic, which highlighted the prevalence and impact of post-viral smell loss on patients' quality of life.
Industry analysts note that successful development of CYR-064 could establish Cyrano Therapeutics as a pioneer in the treatment of chemosensory disorders, potentially opening a new therapeutic category in the pharmaceutical landscape.
As the development progresses toward potential commercialization, both Cyrano Therapeutics and Resyca have expressed commitment to bringing this innovative treatment to patients suffering from chemosensory disorders, underscoring their dedication to scientific innovation and patient-focused drug delivery solutions.
