Cyrano Therapeutics says Phase 2 trial of CYR-064 theophylline intranasal SMI met its primary endpoint

Cyrano Therapeutics has announced that the Phase 2 FLAVOR trial of CYR-064 intranasal theophylline soft-mist spray for the treatment of hyposmia (loss of smell) following viral infection did not demonstrate any safety or tolerability concerns, meeting its primary endpoint. In addition, the company says that the study met several secondary efficacy endpoints related to improvement in sense of smell. CYR-064 is delivered via Resyca’s soft mist nasal spray technology.

Cyrano announced the initiation of the FLAVOR study in October 2023. In addition to the FLAVOR trial, which enrolled 151 patients with post-viral hyposmia, Cyrano has also announced investigator-led studies of CYR-064 in patients with loss of smell due to Parkinson’s disease. In February 2025, Kyorin acquired an option to license Japanese development and marketing rights to the theophylline nasal spray for hyposmia.

Cyrano Therapeutics President and CEO Rick Geoffrion commented, “This is the first randomized, controlled trial to show a pharmaceutical agent can safely improve smell function in patients with persistent post-viral hyposmia. Once a person has lost their sense of smell for as long as 6 months, the chances become extremely small that their sense of smell will return.  Also, when the sense of smell is lost, people also lose up to 80% of their perception of taste.  So in general we are talking about the impairment of as many as 2 out of the main 5 human senses. CYR-064 has the potential to be the first approved therapy for millions suffering from this serious condition, one with no effective treatment today.”

Read the Cyrano Therapeutics press release

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