Cyrano Therapeutics Announces the Launch of an Investigator-Initiated Clinical Study Evaluating CYR-064 for the Loss of Smell (Hyposmia) in Parkinson's Disease Patients

Potential New Therapeutic to Address Chronic Smell Loss in Parkinson's Patients, Affecting Quality of Life and Nutritional Health

The Company's Current Clinical Program is Led by a 150-Subject Phase 2 Trial Currently Enrolling Patients to Evaluate CYR-064 in Post-Viral Smell Loss

DELRAY BEACH, Fla., Feb. 4, 2025 /PRNewswire/ -- Cyrano Therapeutics, Inc., a clinical-stage regenerative medicine company pioneering the development of treatments for smell loss, announced today that it is providing clinical material to support an investigator-led feasibility study evaluating CYR-064 in Parkinson's Disease patients.

CYR-064, Cyrano Therapeutics' lead product, is also currently being evaluated for the treatment of patients suffering from hyposmia and anosmia with various causes, including post-viral hyposmia, in a 150-subject, randomized placebo-controlled Phase 2 clinical study being conducted at 14 sites in the U.S. Top-line data from this trial is expected in the second half of 2025.

Hyposmia and anosmia, the partial or complete loss of smell, affect approximately 95% of the one million individuals in the U.S. living with Parkinson's disease, often serving as one of the earliest symptoms of the condition. Loss of smell typically precedes motor symptoms by five or more years, significantly impacting quality of life by diminishing the perception of taste, contributing to reduced appetite, and leading to weight loss—a common challenge for Parkinson's patients.

"The potential to restore the sense of smell in Parkinson's patients represents a significant step forward in addressing an often-overlooked aspect of the disease that decreases a patient's quality of life and contributes to the decline of their nutritional health," said Rick Geoffrion, co-founder and CEO of Cyrano Therapeutics. "We are excited to support this important investigator-initiated study, which aligns with our mission to improve the lives of individuals living with chronic loss of smell and the associated loss of taste perception."

The new study, titled "A Single Arm Feasibility Study for the Treatment of Parkinson's Disease Related Hyposmia Using CYR-064 Theophylline Spray" (Protocol No. CYR-064-12), is being conducted under the leadership of David Silvers, MD, FAAN, in Palm Beach Gardens, Florida. The 32-week study will enroll approximately 15-20 adult patients aged 18 to 80 years with moderate to severe hyposmia due to Parkinson's disease. The study protocol includes a 24-week treatment period during which patients will receive a twice daily dose of CYR-064 through two sprays per nostril.

The purpose of the study is to evaluate the feasibility, safety, and potential effectiveness of CYR-064 in improving the sense of smell and taste perception in affected individuals. CYR-064 delivers theophylline, which is commonly used in the treatment of asthma and chronic obstructive pulmonary disease (COPD). While theophylline is FDA-approved for oral and intravenous use in COPD, systemic delivery of the drug causes side effects and drug interactions which limit its potential as a therapy for smell loss. CYR-064 is a novel formulation intended for intranasal administration with a proprietary spray device technology enabling targeted delivery to the olfactory region.

"Hyposmia is a challenging and debilitating symptom for many Parkinson's patients, and innovative approaches like CYR-064 are critically needed," said Dr. Silvers, principal investigator of the study. "We look forward to assessing this promising therapy's potential to address a significant unmet need in Parkinson's care."

This investigator-initiated study represents Cyrano Therapeutics' commitment to expanding the therapeutic potential of CYR-064 beyond post-viral smell loss, building on the company's robust clinical program. 

About Hyposmia
Hyposmia, including post-viral hyposmia, is an increasingly prevalent and serious chronic sensory condition for which there is no approved drug therapy and limited treatment options. Hyposmia causes significant impairment in quality of life for many sufferers. Moreover, in older individuals, hyposmia is associated with an increased risk of cognitive impairment and mortality. There is currently no FDA-approved therapy indicated for the treatment of smell loss.

About Gardens Neurology, Palm Beach Gardens, FL
Investigator: Dr. David Silvers, Board Certified in Neurology, Electrodiagnostic Medicine/EMG and is a Diplomate in Neuromuscular Medicine as well as a Diplomate in Behavioral Neurology and Neuropsychiatry. Gardens Neurology is accepting new patients and second opinion consultations.  To make an appointment please call (561) 799-2831

About Cyrano Therapeutics
Cyrano Therapeutics is a private, venture-backed clinical stage regenerative medicine company. Since our foundation, we have been working diligently to develop therapies for people struggling with the loss of smell and taste. To learn more, please visit cyranotherapeutics.com

Media Contact:
Tiberend Strategic Advisors, Inc. 
Eric Reiss
[email protected] 

SOURCE Cyrano Therapeutics