Cyrano Therapeutics is savoring a phase 2 victory. With the Flavor study hitting its primary endpoint, the biotech is preparing to take its treatment for persistent smell loss into phase 3 in the second half of the year.
The midphase trial randomized 151 patients with persistent post-viral loss of smell to receive CYR-064 or placebo. CYR-064 is an intranasal formulation of the phosphodiesterase inhibitor theophylline. Scientists have explored the potential for theophylline to fix smell loss in patients with hyposmia for decades—one clinical trial began in 2000—and the effect of COVID-19 infection on smell fueled renewed interest in the idea.
Cyrano reported the trial met its primary safety and tolerability endpoint without publishing any numbers behind the win. No patients had treatment-related serious adverse events.
The company also said CYR-064 demonstrated durable improvements in smell across multiple secondary efficacy endpoints. The trial used taste and smell patient-reported outcomes to assess the effect of administering CYR-064 twice a day for 24 weeks.
The biotech has yet to share efficacy data, with plans to share detailed data at a medical conference this year.
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The biotech will ready the full data for publication while preparing to start a phase 3 trial. A successful pivotal program could make CYR-064 the first approved treatment for hyposmia, a condition Cyrano said affects millions of people. Cyrano founder and CEO Rick Geoffrion said in a statement that people who lose their sense of smell for six months—the population targeted in the phase 2 trial—are very unlikely to regain the sense.
Cyrano funded the phase 2 trial by raising $21.8 million across two rounds in 2020 and 2024. The biotech granted Kyorin Pharmaceutical an option to license CYR-064 in Japan last year. Cyrano could receive an upfront fee, milestones and royalties if Kyorin exercises the option. The biotech has yet to disclose the deal’s financial value.
