Cyrano Therapeutics has started enrolment in the Phase II FLAVOR trial of CYR-064, a new soft-mist nasal spray product candidate, for post-viral smell loss (hyposmia).
The placebo-controlled, multi-dose study will evaluate the local nasal safety, effectiveness and tolerability of CYR-064 against placebo in post-viral hyposmia treatment for six months.
Cyrano plans to enrol around 150 patients in the randomised and double-blinded study.
The multi-institutional prospective trial is being carried out at 15 US clinical sites.
Cyrano Therapeutics president and CEO Rick Geoffrion said: “We are excited to announce a significant milestone in our commitment to advancing medical science and improving the lives of those affected by post-viral smell loss.
“With the enrolment of the first patients in our Phase II trial of CYR-064, we take a giant step forward in addressing a pressing health concern.
“In a world where post-viral smell loss continues to affect an ever-growing number of individuals, we're dedicated to pioneering solutions that make a difference.”
Post-viral hyposmia is a growing and serious chronic sensory condition, with no approved drug treatment available at present.
Hyposmia in older individuals is linked to increased cognitive impairment and mortality risk.
Before the Covid-19 pandemic, approximately eight million people in Europe and the US experienced long-term post-viral hyposmia.
This pandemic has led to a significant rise in the number of people experiencing long-term post-viral hyposmia.