Cyrano Therapeutics is set to initiate a Phase II clinical trial of its soft mist nasal spray therapy, CYR-064, for the treatment of post-viral smell loss (Hyposmia).

The company’s decision comes after it secured US Food and Drug Administration (FDA) clearance for CYR-064’s investigational new drug (IND) application.

The placebo-controlled, randomised, multi-dose Phase II trial of CYR-064 has been designed for evaluating the tolerability, local safety, and effectiveness in treating patients who have lost their sense of smell after recovering from a viral infection. 

At present, there is no drug therapy approved by the FDA to treat Hyposmia.

The trial is expected to enrol subjects at 20 US clinical sites and will assess the therapy for a period of six months.

Cyrano Therapeutics CEO Rick Geoffrion said: “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.”

Prior to Covid-19, eight million patients in the US and EU suffered from post-viral smell loss for a long-term period. 

Since the beginning of the pandemic, this has increased to more than 40 million patients. 

Cyrano Therapeutics chief medical advisor Ron Kuppersmith said: “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.”