#United States #Delray Beach #Parkinson's Disease #Cyrano Therapeutics #CYR-064

Cyrano Therapeutics Announces Clinical Study for Smell Loss in Parkinson's Patients

Cyrano Therapeutics, a clinical-stage regenerative medicine company focused on addressing smell loss, has announced a significant advancement in its clinical trials. The company is supporting an investigator-led feasibility study aimed at evaluating their leading product, CYR-064, for individuals suffering from hyposmia and anosmia linked to Parkinson’s disease.

Overview of CYR-064

CYR-064 is currently under investigation for its efficacy in treating various types of smell loss, including post-viral conditions, through a substantial randomized placebo-controlled Phase 2 clinical trial involving 150 subjects spread across 14 locations in the United States. Preliminary results from this trial are anticipated in the latter half of 2025. Approximately 95% of the one million Parkinson's disease patients in the U.S. experience some form of smell impairment, which can precede motor symptoms by up to five years. This condition profoundly impacts quality of life, leading to a reduced appetite and potential weight loss because the sense of smell is closely tied to taste perception.

Rick Geoffrion, the co-founder and CEO of Cyrano Therapeutics, emphasized the importance of this study, stating, "Restoring the sense of smell in Parkinson's patients addresses an often-ignored aspect of their condition which seriously affects their quality of life and nutritional wellbeing. We are thrilled to support this investigator-initiated study, as it echoes our mission to improve the lives of individuals facing chronic smell loss."

The New Feasibility Study

The latest initiative, named "A Single Arm Feasibility Study for the Treatment of Parkinson's Disease Related Hyposmia Using CYR-064 Theophylline Spray" (Protocol No. CYR-064-12), will be steered by Dr. David Silvers in Palm Beach Gardens, Florida. The study is set to enroll around 15–20 adults aged 18 to 80 who are impacted by moderate to severe hyposmia due to Parkinson’s disease. Over a 32-week period, participants will receive treatment via a twice-daily dosage of the CYR-064 spray, specifically designed to target the olfactory region in the nasal cavity.

The primary goal of this study is to examine the safety, feasibility, and effectiveness of CYR-064 in enhancing both smell and taste perception for those affected. CYR-064 incorporates theophylline, a drug typically used in managing asthma and chronic obstructive pulmonary disease (COPD). While theophylline is FDA-approved for oral and intravenous applications, its systemic use can lead to adverse effects and various drug interactions, limiting its utility in treating smell disorders. The innovative formulation of CYR-064 aims to provide a more localized delivery method that mitigates systemic side effects.

Importance of Hyposmia Treatment

Dr. Silvers, who serves as the principal investigator, noted the challenges posed by hyposmia for many Parkinson's patients. He stressed the urgent need for innovative approaches like CYR-064, saying, "We eagerly anticipate assessing this promising therapy's potential to meet a substantial unmet need in Parkinson's care."

This study not only aligns with Cyrano Therapeutics' commitment to expanding the therapeutic applications of CYR-064 but also represents a concerted effort to broaden the understanding and management of chronic smell disorders beyond just post-viral implications.

Understanding Hyposmia

Hyposmia, particularly post-viral hyposmia, represents an increasingly recognized and serious ongoing sensory condition lacking approved treatment options. The impairment significantly impacts the quality of life for many individuals. Moreover, older adults facing hyposmia are at an elevated risk for cognitive decline and increased mortality. Despite its prevalence and consequences, the FDA has yet to approve any therapies specifically indicated for the treatment of smell loss.

About Cyrano Therapeutics

Cyrano Therapeutics, a privately held, venture-backed organization, has dedicated its efforts to finding effective therapies for those struggling with smell and taste loss since its inception. For further information, visit their website at cyranotherapeutics.com.

Inquiries related to media can be directed to Tiberend Strategic Advisors, Inc., where Eric Reiss is available for contact.