Merck partners Remepy in PDURS-focused alliance

Merck KGaA has started working with Remepy on the development of hybrid drugs that combine a medicine with digital therapeutic (DTx) software to enhance its efficacy.

Initially focusing on Merck's fast-growing rare tumour business – ramped up by the company's $3.9 billion acquisition last year of SpringWorks and a licensing deal with Abbisko Therapeutics – the alliance may be extended in future to include additional therapeutic areas, according to the two companies.

There has been growing interest in the hybrid drug approach since the FDA issued its Prescription Drug Use-Related Software (PDURS) guidance in 2023, covering a regulatory framework for digital tools – such as apps, websites, or connected devices – that are provided by pharmaceutical companies to support the use of their prescription medicines.

In a nutshell, the PDURS framework allows pharmaceutical manufacturers to add software to a drug label, provided it demonstrates clinical benefit. Aside from Merck, other pharma companies that have embraced the PDURS concept include Pfizer and Otsuka, the latter via an alliance with Click Therapeutics.

The approach to PDURS taken by Remepy is focused on the development of mobile apps that can be used to combine medicines with "personalised digital therapeutic protocols" that deliver "evidence-based motor, physical, and cognitive interventions."

The company – which officially launched in 2024 with $15 million in seed funding – maintains that combining medication with behavioural and therapeutic interventions can deliver the most effective care to patients. It has generated experimental data showing that its software can modulate physiological measures, including blood and immune system biomarkers.

According to its website, Remepy's lead in-house hybrid drug is Hybridopa, scheduled to start phase 3 testing in the latter half of this year, that is designed to enhance the impact of the Parkinson's disease therapy levodopa by delivering motor and cognitive training for the brain.

The company also has programmes in oncology, combining pharmacological treatment with complementary medicines and lifestyle interventions, as well as women's health, particularly focusing on preventing pre-term births.

"Remepy's hybrid drug platform combines traditional drugs with evidence-based AI-enabled digital interventions delivering personalised, adaptive, integrative treatment," said Dr Michal Tsur, Remepy's co-founder and co-chief executive.

"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," she added. "We are looking forward to accelerating the delivery of innovative and effective therapies to patients who need them most."