Study of CYR-064 Versus Placebo in Patients.

Hyposmia Clinical Trial

Official title:

A Randomized, Double-Blinded, Placebo-Controlled Trial to Determine The Safety and Efficacy of CYR-064

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06019000
• Other study ID #: CYR-064-01
• Status: Recruiting
• Phase: Phase 2
• Start date: September 26, 2023
• Est. completion date: January 30, 2025

Study information

• Verified date: December 2023
• Source: Cyrano Therapeutics, Inc.
• Contact: Rick Geoffrion
• Phone: 9258226461
• Email: Rick[@]cyranotherapeutics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

The purpose of this study is to determine the safety and effectiveness of CYR-064 in a randomized, double-blinded, placebo-controlled trial to determine the safety and efficacy of CYR064.

The study will take approximately 32 weeks which will include a 4-week screening period to evaluate if participants are right for the Study, followed by a 24-week Treatment Period, and a 1 week follow up after participants have completed the Study. About 150 subjects will participate in this study in about 25 research sites in the United States.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: January 30, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Able to provide written informed consent.

• Male or female 18-65 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.

Exclusion Criteria:

• 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.

• General Exclusions Any female who is pregnant, planning to become pregnant during the study, or who is lactating.

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.

Related Conditions & MeSH terms

• Anosmia
• Hyposmia

Intervention

Combination Product:
• CYR-064
CYR-064 is a nasal solution.

Locations

Country	Name	City	State
United States	Centers for Advanced ENT	Baltimore	Maryland
United States	Specialty Physician Associates	Bethlehem	Pennsylvania
United States	ENTAAFL	Boca Raton	Florida
United States	Medical University of South Carolina-MUSC	Charleston	South Carolina
United States	Rush University Medical Center	Chicago	Illinois
United States	Colorado ENT & Allergy	Colorado Springs	Colorado
United States	Houston Methodist	Houston	Texas
United States	KU Medical Center-University of Kansas	Kansas City	Kansas
United States	Advanced ENT and Allergy	Louisville	Kentucky
United States	Kentuckian ENT	Louisville	Kentucky
United States	Tandem Clinical Research	Marrero	Louisiana
United States	Charleston ENT and Allergy	North Charleston	South Carolina
United States	ENTAAFL	Plantation	Florida
United States	ENTAAFL	Port Saint Lucie	Florida
United States	Ear Nose Throat & Allergy Associates	Puyallup	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Cyrano Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (9)

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

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 — View Citation

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-O — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Secondary Outcome-improvement on NRS-11 Smell-PRO	Improvement in patient reported NRS-11 Smell-PRO (scale of 0-10) in CYR-064 low dose and high dose groups as compared with placebo from Baseline to Week 24.	Approximately 24 weeks
Secondary	Secondary Outcome-improvement on NRS-11 Taste-PRO	Improvement in patient reported NRS-11 Taste-PRO (scale of 0-10) in CYR-064 low dose and high dose groups as compared with placebo from Baseline to Week 24.	Approximately 24 weeks
Secondary	Secondary Outcome-Mean Change in NRS-11 Smell-PRO	Mean Change in NRS-11 Smell-PRO from Baseline to Week 24 between CYR-064 low and high dose and placebo from Baseline to Week 24	Approximately 24 weeks
Secondary	Secondary Outcome-Mean Change in NRS-11 Taste-PRO	Mean Change in NRS-11 Taste-PRO from Baseline to Week 24 between CYR-064 low and high dose and placebo from Baseline to Week 2	Approximately 24 weeks
Secondary	Change in Visual Rating Scale (VRS) scores	Change in Visual Rating Scale (VRS) scores in CYR-064 low dose and high dose groups as compared with placebo from Baseline to Week 24.; VRS high dose versus placebo; VRS low dose versus placebo; VRS low and high dose combined versus placebo	Approximately 24 weeks