Cyrano Therapeutics said that the FDA has cleared the company’s IND and that Cyrano now plans to move ahead with a Phase trial of CYR-064 nasal soft mist theophylline in patients who experienced hyposmia (loss of smell) following a viral infection. In December 2020, Cyrano announced that it had raised $12.8 million for a Phase 2 trial of CYR-064. The six-month trial is expected to enroll patients at 20 US sites.
Cyrano CEO Rick Geoffrion commented, “Clearance of the IND for CYR-064 brings us one step closer to our goal of developing medicines with the potential to benefit post-viral hyposmia patients, especially those affected by COVID-19. Our clinical team has been diligently preparing for this moment and is now laser focused on enrolling our first patient, which we expect will occur in the second quarter of 2023.”
Chief Medical Advisor Ron Kuppersmith said, “Loss of the sense of smell has a significant impact on quality of life and presents safety issues for all who are affected. As a practicing otolaryngologist-head and neck surgeon, the inability to offer any proven intervention for patients with this common condition is very frustrating. While the inability to administer any therapy that can help is a challenge for physicians, the situation is even more frustrating for patients suffering with the condition. The potential for CYR-064 to help patients with post-viral hyposmia will represent a major breakthrough for these patients and address a major unmet clinical need.”
Read the Cyrano Therapeutics press release.
