After cough drug setback, Merck partners Hyfe’s tracking app

Merck & Co has signed a deal with digital health firm Hyfe that will see its cough-detecting smartphone app offered to patients in the US.

Hyfe’s app uses artificial intelligence to monitor coughing patterns by recording factors like volume, frequency, amplitude and context whilst running in the background on an iOS or Android device.

The app attracted a lot of attention during the pandemic as a potentially way to differentiate COVID-19 from other respiratory infections, but Merck says it will use it more generally as a cough frequency tool that can be added into its consumer disease educational efforts.

It’s worth noting that the agreement has been forged a few months after Merck suffered a setback in its attempt to secure FDA approval for a potentially first-in-class drug for chronic cough – oral P2X3 receptor antagonist gefapixant – on the strength of its effects on 24-hour cough frequency in two placebo-controlled phase 3 trials.

The FDA rejected the application, asking for more information on the “measurement of efficacy” used in the trial, delaying the drug and giving Bayer and Bellus Health an opportunity to close the gap with their rival candidates in the US.

Gefapixant is already approved in Japan as Lyfnua, but Bayer and Bellus are in hot pursuit of the drug in the US with their respective eliapixant and BLU-5937 candidates, which are both in late-stage clinical testing.

Merck hasn’t indicated specifically that Hyfe’s app will be deployed in gefapixant studies, it is a possibility and there’s no word yet from the company on the outcome of discussions with the FDA on a path forward for its drug.

The statement on the Hyfe alliance notes that it could be useful for “the estimated 1.2 million adults in the US who suffer from chronic cough.”

“The overwhelming majority of people cannot even come close to accurately estimating the number of times they cough per day,” said Peter Small, Hyfe’s chief medical officer.

“In order to help diagnose and treat patients, cough frequency and sound should be monitored and measured with the same accuracy as blood pressure, temperature, heartbeat and other biomarkers that are essential for assessing health and medical conditions.”

Merck’s interest in Hyfe is another example of big pharma’s move into the digital health arena with tools that can help patients monitor and track health conditions.

In April, Pfizer made a $75 million offer to buy ResApp and ResAppDx platform, which can be used to detect a wide range of respiratory conditions such as pneumonia, asthma, bronchiolitis and chronic obstructive pulmonary disease (COPD) by monitoring cough and breathing sounds.

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