Hyfe cough monitor lands primary-endpoint role in Japan DTx trial

Hyfe said Japan’s PMDA agreed to use its CoughMonitor Suite as the primary endpoint tool in a pivotal trial of a prescription digital therapeutic for chronic cough co-developed with KYORIN Pharmaceutical. The decision could help set a regulatory precedent for wearable-based endpoints in late-stage drug and digital health studies.

Why it matters: - PMDA’s acceptance of a wearable cough monitor as a pivotal-trial primary endpoint is a regulatory first for chronic cough digital therapeutics. - The decision could create a reference point for objective, continuous cough measurement in future digital health and respiratory studies. - If the trial succeeds and PMDA approves the product, the therapy would become the world’s first prescription digital therapeutic for chronic cough.

What happened: - Hyfe said Japan’s Pharmaceuticals and Medical Devices Agency agreed to use CoughMonitor Suite, or CMS, as the primary endpoint measurement tool in an upcoming pivotal clinical trial. - KYORIN Pharmaceutical is co-developing the prescription digital therapeutic for chronic cough, and KYORIN is sponsoring the trial. - The trial is planned as a single-blind, controlled, multi-site study in Japan. - The study will evaluate efficacy and safety when the digital therapeutic is used with standard of care in patients with chronic cough who have had insufficient improvement on existing therapies.

The details: - CoughMonitor Suite is a wrist-worn wearable paired with a clinical-research dashboard. - Hyfe said CMS has been used in more than 55 studies as an exploratory endpoint and as a primary endpoint in Phase 1 and field research. - Hyfe said this is the first time a fully automated cough monitoring tool will serve as the primary endpoint in a pivotal clinical trial. - The trial is designed to generate clinical evidence for PMDA review of the digital therapeutic. - The product is anticipated to be reviewed as a Class II Software as a Medical Device, or SaMD. - Hyfe said PMDA had no specific guidance for digital health endpoints before this agreement. - Hyfe’s website says the company also is developing ResolveDTx outside Japan, a digital therapeutic for chronic cough. More information is available at Hyfe’s website.

Between the lines: - The regulatory win suggests wearable-derived data is moving from exploratory support into the core evidence package for late-stage development. - That shift may matter for drugmakers and digital health companies trying to prove treatment effect with objective, continuous measurements instead of short clinical snapshots. - Hyfe CEO Tamsin Chislett called the PMDA decision a defining moment for digital endpoints in life sciences. - KYORIN President and CEO Yutaka Ogihara said the trial could broaden digital health integration in Japanese clinical practice.

What’s next: - The pivotal trial will move forward in Japan under PMDA-aligned endpoint measurement. - If the study meets its endpoints and PMDA grants approval, the resulting product would be the first prescription digital therapeutic for chronic cough. - Hyfe said the PMDA decision may inform endpoint strategies as the field matures.

The bottom line: - Hyfe and KYORIN are trying to prove that wearable cough data can anchor pivotal evidence for a regulated chronic cough treatment, not just support it.