Study of CYR-064 Versus Placebo in Patients.

NCT06019000 | Completed Phase 2 FDA Drug FDA Device

• 1 other identifier: CYR-064-01
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 14

Brief Summary

Randomized, double-blinded, placebo-controlled trial to determine the safety and efficacy of CYR-064.

Conditions

Hyposmia

Keywords

post viral smell loss

Outcome Measures

Primary Outcomes (1)

• Primary Outcome - Safety and Tolerability

  The count and percentage of patients reporting AEs, SAEs, and SUSARs will be summarized overall, by System Organ Class, Preferred Term within the System Organ Class, maximum severity, and relationship to study drug. All other safety parameters, including clinical laboratory values through blood draws, will be summarized using descriptive statistics for continuous variables and counts and percentages for categorical variables. All changes in nasal mucosal appearance will be noted.

  Approximately 32 weeks

Secondary Outcomes (5)

• Secondary Outcome-improvement on NRS-11 Smell-PRO

  Approximately 24 weeks

• Secondary Outcome-improvement on NRS-11 Taste-PRO

  Approximately 24 weeks

• Secondary Outcome-Mean Change in NRS-11 Smell-PRO

  Approximately 24 weeks

• Secondary Outcome-Mean Change in NRS-11 Taste-PRO

  Approximately 24 weeks

• Change in Visual Rating Scale (VRS) scores

  Approximately 24 weeks

Study Arms (3)

CYR-064 dose 1

ACTIVE COMPARATOR

Treatment with nasal solution of CYR-064 twice a day for 24 weeks. CYR-064 will be self-administered by patients.

Combination Product: CYR-064

CYR-064 dose 2

EXPERIMENTAL

Treatment with nasal solution of CYR-064 twice a day for 24 weeks. CYR-064 will be self-administered by patients.

Combination Product: CYR-064

Placebo

PLACEBO COMPARATOR

Treatment with Placebo nasal solution for 24 weeks. CYR-064 will be self-administered by patients.

Combination Product: CYR-064

Interventions

CYR-064 COMBINATION_PRODUCT

CYR-064 is a nasal solution.

CYR-064 dose 1; CYR-064 dose 2; Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to provide written informed consent.
• Male or female 18-70 years of age.
• Endoscopy of the nasal cavity showing no structural or pathologic issues leading to hyposmia (nasal polyps, sinusitis, infection, etc.) that in the opinion of the Investigator, believes would hinder the delivery of study drug to the olfactory receptors.
• CT scan of the nasal cavity after the onset of hyposmia (within prior 2 years) prior to Baseline showing no structural or pathologic issue leading to hyposmia that in the opinion of the Investigator, believes would hinder the delivery of study drug to the olfactory receptors.
• Willing and able to self-administer the study drug, follow the study drug administration instructions, comply with study procedures, and participate in the scheduled study visits specified in this protocol.

You may not qualify if:

• History of traumatic brain injury, Parkinson's disease, early dementia, Alzheimer's disease, or any other condition in which hyposmia is not expected to improve in the opinion of the Investigator, such as history of congenital or idiopathic hyposmia or a surgical procedure that led to hyposmia.
• History of surgery that led to hyposmia.
• Concomitant Medical Conditions
• Current symptoms or signs of an acute respiratory viral illness at Screening or Baseline.
• Chronic viral infection or immunodeficiency condition (e.g., medical history of human immunodeficiency virus) based on medical records.
• Any active malignancy.
• Any concomitant medical condition that in the opinion of the Investigator, compromises patient safety or compliance with the study protocol or collected data.
• History of moderate to severe Substance Use Disorder within the past 3 years as assessed by the Investigator.
• History of persistent chronic sinusitis without polyps or chronic sinusitis with polyps.
• Use or planned use of tobacco or nicotine-containing products, including smoking, smokeless tobacco, e-cigarettes, or nicotine replacement products within 3 months prior to Screening through EOS.
• Unwilling or unable to discontinue current or planned use of over the counter or prescription medication administered intranasally, with the exception of nasal saline.
• Use or planned use of another investigational drug within 4 weeks prior to Screening through Follow-Up.
• Receiving any concomitant medication/therapy that would, in the opinion of the Investigator, compromise patient safety or compliance with the study protocol or collected data.
• Vulnerable patients. Any condition or abnormality (including clinical laboratory, physical examination, or vital sign abnormalities), current or past, that, in the opinion of the Investigator, would compromise the efficacy evaluation, safety of the patient, or would interfere with or complicate study procedures or assessments.

Sponsors & Collaborators

• Cyrano Therapeutics, Inc.: lead

Study Sites (14)

Colorado ENT & Allergy

Colorado Springs, Colorado, 80923, United States

Location

ENTAAFL

Boca Raton, Florida, 33487, United States

Location

ENTAAFL

Plantation, Florida, 33324, United States

Location

ENTAAFL

Port Saint Lucie, Florida, 34952, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

KU Medical Center-University of Kansas

Kansas City, Kansas, 66160-8500, United States

Location

Advanced ENT and Allergy

Louisville, Kentucky, 40220, United States

Location

Tandem Clinical Research

Marrero, Louisiana, 70072, United States

Location

Centers for Advanced ENT

Baltimore, Maryland, 21204, United States

Location

Specialty Physician Associates

Bethlehem, Pennsylvania, 18017, United States

Location

Medical University of South Carolina-MUSC

Charleston, South Carolina, 29425, United States

Location

Charleston ENT and Allergy

North Charleston, South Carolina, 29406, United States

Location

Houston Methodist

Houston, Texas, 77030, United States

Location

Ear Nose Throat & Allergy Associates

Puyallup, Washington, 98374, United States

Location

Related Publications (9)

• Henkin RI. Growth Factors in Olfaction. In: Preedy VR, editor. Handbook of Growth and Growth Monitoring in Health and Disease. New York, NY: Springer New York; 2012. p. 1417-36.

  BACKGROUND

• Henkin RI, Abdelmeguid M. Improved Smell and Taste Dysfunction with Intranasal Theophylline. Am J Otolaryngol Head Neck Surg. 2019;2(9):1070.

  BACKGROUND

• Henkin RI, Levy LM, Fordyce A. Taste and smell function in chronic disease: a review of clinical and biochemical evaluations of taste and smell dysfunction in over 5000 patients at The Taste and Smell Clinic in Washington, DC. Am J Otolaryngol. 2013 Sep-Oct;34(5):477-89. doi: 10.1016/j.amjoto.2013.04.006. Epub 2013 Jun 2.

  PMID: 23731850 RESULT

• Henkin RI. Comparative monitoring of oral theophylline treatment in blood serum, saliva, and nasal mucus. Ther Drug Monit. 2012 Apr;34(2):217-21. doi: 10.1097/FTD.0b013e3182492a20.

  PMID: 22377744 RESULT

• Henkin RI, Hosein S, Stateman WA, Knoppel AB, Abdelmeguid M. Improved smell function with increased nasal mucus sonic hedgehog in hyposmic patients after treatment with oral theophylline. Am J Otolaryngol. 2017 Mar-Apr;38(2):143-147. doi: 10.1016/j.amjoto.2016.11.010. Epub 2016 Nov 23.

  PMID: 27923495 RESULT

• Henkin RI, Schultz M, Minnick-Poppe L. Intranasal theophylline treatment of hyposmia and hypogeusia: a pilot study. Arch Otolaryngol Head Neck Surg. 2012 Nov;138(11):1064-70. doi: 10.1001/2013.jamaoto.342.

  PMID: 23165381 RESULT

• Henkin RI, Velicu I. cAMP and cGMP in nasal mucus related to severity of smell loss in patients with smell dysfunction. Clin Invest Med. 2008;31(2):E78-84. doi: 10.25011/cim.v31i2.3367.

  PMID: 18377764 RESULT

• Henkin RI, Velicu I, Schmidt L. An open-label controlled trial of theophylline for treatment of patients with hyposmia. Am J Med Sci. 2009 Jun;337(6):396-406. doi: 10.1097/MAJ.0b013e3181914a97.

  PMID: 19359985 RESULT

• Henkin RI, Velicu I, Schmidt L. Relative resistance to oral theophylline treatment in patients with hyposmia manifested by decreased secretion of nasal mucus cyclic nucleotides. Am J Med Sci. 2011 Jan;341(1):17-22. doi: 10.1097/MAJ.0b013e3181f1fdc8.

  PMID: 21191261 RESULT

MeSH Terms

Conditions

Anosmia

Condition Hierarchy (Ancestors)

Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mas Takashima, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: There will be a placebo match and blinded randomization.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study treatment of CYR-064 is administered for a 24-week Treatment Period. Patients who meet all study criteria and have consented to participation will be randomized (1:1:1) to three parallel study arms, with two different dose strengths and a placebo group over 24 weeks. CYR-064 dose 1 CYR-064 dose 2 Placebo

Study Record Dates

• First Submitted: May 11, 2023
• First Posted: August 31, 2023
• Study Start: September 26, 2023
• Primary Completion: November 11, 2025
• Study Completion: November 21, 2025
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (14)