German drugmaker Merck KGaA is teaming up with Israeli biotech Remepy to develop so-called hybrid drugs that pair a pharmaceutical with a personalized, AI-driven digital component to enhance the therapy.
The collaboration will initially focus on drugs in Merck’s rare tumor portfolio “where there is strong unmet need and where patients can benefit from behavioral, physical and supportive care factors—making it a strong potential fit for a hybrid drug approach,” Michal Sur, PhD, Remepy’s co-founder and co-CEO, told Fierce Med Tech in a statement.
For example, a patient receiving a rare tumor therapy might use the digital component daily to follow a structured program tailored to their condition and delivered through an app.
This could include a combination of guided physiotherapy, physical activity, pain or behavioral support, symptom measuring and monitoring and medication tracking, she said.
The FDA has taken steps in recent years to create clearer regulatory routes for integrating digital therapeutics directly into pharmaceutical products.
There are now two main regulatory options to deliver a drug plus software to patients under a single prescription, according to Remepy.
One allows a combined drug and software combination as a new drug—an avenue Remepy is pursuing for its Parkinson’s asset Hybridopa. The second allows drug companies to add label claims based on existing drugs based on the software’s effect on clinical outcomes, the company said.
“The new advances in regulatory frameworks, supporting the integration of software with drugs, enable the pharma industry to use the power of the digital world to differentiate drugs, enhance their efficacy and amplify their label,” Sur said in an April 28 news release.
“We are looking forward to accelerating the delivery of innovative and effective therapies to patients who need them most.”
Remedy described the partnership with Merck as the first of its kind and the first “to amplify drug labels leveraging the emerging FDA frameworks.” Financial terms were not disclosed.
Sur said the two companies hope to eventually explore additional opportunities for hybrid drugs across Merck’s portfolio.
