Seyltx Reports EHR Analysis Results on Refractory Chronic Cough Prevalence

Seyltx, Inc., a clinical-stage biopharmaceutical company based in Cambridge, Massachusetts, has announced significant findings from a study on refractory chronic cough (RCC). The study, which analyzed real-world electronic health record (EHR) data, aimed to determine the prevalence of RCC among adults in the USA. These results are set to be presented at the London International Cough Symposium on July 18, 2024.

The study examined data from 54,958,289 adult patients using the EHR Integrated Database from EVERSANA®. The comprehensive analysis revealed that 2.19% of the adult population in the United States suffers from RCC, translating to approximately 5.9 million adults. The data was collected from records between January 1, 2015, and December 31, 2023, focusing on patients aged 18-90 with over six months of follow-up data.

RCC is defined as a chronic cough persisting for over eight weeks despite treatment attempts. It significantly impacts patients' quality of life, often leading to anxiety, depression, and social isolation. The condition is predominantly observed in women and is frequently under-diagnosed due to limited physician awareness.

Dietrich A. Stephan, Ph.D., CEO of Seyltx, highlighted the importance of this study in accurately diagnosing RCC and optimizing clinical trial enrollment. Seyltx developed a multivariate surrogate diagnostic signature to identify RCC in the absence of an ICD10 code in patients' EHRs. This enabled a precise understanding of the market opportunity and the identification of geographical locations for efficient Phase 2b clinical trial enrollment.

The research, conducted in collaboration with Atropos Health, Inc., identified clinical features commonly associated with RCC through expert interviews and analyzed a total dataset of 94,400,624 patients. Chronic cough patients were identified based on multiple diagnoses and treatments recorded over at least eight weeks. Patients with underlying pathologies were excluded to pinpoint those with RCC. The analysis found that 6.31% of the study group had chronic cough, and 34.65% of these patients were classified as having RCC.

Peter Dicpinigaitis, M.D., a professor at the Albert Einstein School of Medicine and a co-author of the study, emphasized the significant unmet clinical need for RCC treatment. He noted that the economic impact of chronic cough is considerable, accounting for up to 30 million healthcare visits annually. Seyltx's solution, a non-narcotic and non-sedating pill targeting the cough reflex in the brain, shows promise in addressing this issue.

Seyltx's product candidate, ifenprodil, has shown notable antitussive effects in preclinical trials at doses well below the no observed adverse event limit (NOAEL). The Phase 2a clinical trial demonstrated statistically significant reductions in cough counts. The company plans to initiate its Phase 2b clinical trial in early 2025, leveraging de-identified patient-level data to identify high-volume clinical practices and accelerate enrollment.

The study's findings will be published in the Journal of Thoracic Disease. Ifenprodil, a GluN2B antagonist, is considered a new chemical entity (NCE) in major global markets, providing extensive safety data while ensuring exclusivity and intellectual property protection.

Seyltx is actively exploring the potential of ifenprodil for other conditions involving cough hypersensitivity, such as idiopathic pulmonary fibrosis (IPF). Chronic cough, lasting over eight weeks, poses significant physical, social, and psychological challenges. With no specific therapy currently approved for RCC, Seyltx aims to fill this gap with its innovative therapeutic approach.