Cyrano Therapeutics Completes Enrollment in Phase 2 FLAVOR Trial of CYR-064 for Post-Viral Smell Loss

Data Expected in Q4 2025 from Study Evaluating the First Potential Therapy for Post-Viral Hyposmia

DELRAY BEACH, Fla., April 10, 2025 /PRNewswire/ -- Cyrano Therapeutics, Inc., a clinical-stage regenerative medicine company pioneering the development of treatments for smell loss, today announced that it has completed enrollment in the Phase 2 FLAVOR trial, a randomized, double-blinded, placebo-controlled, multi-dose clinical study evaluating CYR-064, its novel soft-mist nasal spray product candidate, for the treatment of post-viral hyposmia (smell loss).  Data from the trial is expected in the fourth quarter of 2025.

The FLAVOR trial enrolled 150 patients across 14 clinical sites in the United States to assess the safety, tolerability, and efficacy of CYR-064 for the treatment for post-viral hyposmia compared to placebo over a six-month period. Post-viral hyposmia, a chronic sensory condition with no FDA-approved treatment, is an increasingly prevalent issue affecting more than 60 million people between the US, Europe and Japan, and millions more worldwide.

"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, Inc. "We are deeply grateful to the patients and investigators who have contributed to this critical research, and we look forward to analyzing the data, which will be instrumental in guiding the next phase of CYR-064's development."

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. A key component of CYR-064's delivery system is Ursatec's 3K^® pumpsystem in combination with the Resyca soft mist spray technology, which enables precise, targeted deposition of the drug into the olfactory region. By utilizing a soft-mist formulation with controlled droplet size and low spray velocity, the 3K^®-Ultra Soft system enhances drug deposition and absorption and increases the potential for therapeutic efficacy. This advanced delivery mechanism is designed to optimize patient outcomes while ensuring ease of administration.

"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," said Mas Takashima, MD FACS, Professor and Chairman of the Department of Otolaryngology – Head and Neck Surgery at Houston Methodist Hospital and the principal investigator for the FLAVOR trial. "We are encouraged by the commitment of the patients who participated and are eager to review the results and validate the promise of CYR-064 which has the potential to provide the first evidence-based treatment for patients suffering from post-viral hyposmia.."

About Cyrano Therapeutics
Cyrano Therapeutics is a private, venture-backed clinical stage regenerative medicine company. Since our foundation, we have been working diligently to develop therapies for people struggling with the loss of smell and taste.  To learn more, please visit cyranotherapeutics.com.

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Eric Reiss
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SOURCE Cyrano Therapeutics