Cyrano Therapeutics Announces FDA Clearance Of IND Application For Phase 2 Clinical Trial Of CYR-064 To Treat Post-Viral Smell Loss (Hyposmia)

• Currently no FDA-approved therapy for this serious condition
• Initiation of Phase 2 clinical trial expected to occur in Q2 2023

Delray Beach, FL /PRNewswire/ - Cyrano Therapeutics, a biopharmaceutical company developing medicines for patients with hyposmia (smell loss), announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for CYR-064, paving the way for the company to initiate a randomized, placebo-controlled multi-dose Phase 2 clinical trial of its soft mist nasal spray therapy to treat patients who have lost their sense of smell following recovery from a viral infection. There is currently no FDA-approved drug therapy to treat post-viral smell loss.

"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," said Rick Geoffrion, Chief Executive Officer of Cyrano Therapeutics. "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."

"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," said Ron Kuppersmith, MD, Chief Medical Advisor of Cyrano Therapeutics and Past-President of the American Academy of Otolaryngology – Head and Neck Surgery. "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."

The Phase 2 clinical trial is designed to assess the local safety, tolerability, and effectiveness of treating post-viral hyposmia. The study is expected to enroll patients at twenty clinical sites in the United States and will evaluate treatment over a six-month time period.

About Post-Viral Hyposmia
Post-viral smell loss is a growing global issue. Prior to the COVID-19 pandemic, 8 million patients in the U.S. and EU suffered from long-term post-viral smell loss. This has grown to more than 40 million patients since the beginning of the COVID-19 pandemic. Approximately 15% of 2020-era COVID-19 patients and ~5% of 2021 and 2022-era COVID-19 patients suffer from long-term smell loss. At current rates, >10,000 patients each day in the U.S .and >10,000 patients each day in the EU are contracting long-term smell loss.

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 flavor. To learn more, please visit cyranotherapeutics.com.