Merck KGaA has inked a collaboration deal with Israeli-US startup, Remepy, to explore the therapeutic potential of combination drug and app-based approaches in rare oncology – marking the first big pharma foray into this new evolving area for digital therapies.
Through this agreement, Merck KGaA and Remepy will collaborate on multiple US-based programmes to develop “Hybrid Drugs”, which combine pharmaceuticals with personalised, mobile app-based digital therapies to boost patient outcomes over a drug alone.
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While Remepy will be eligible for development support, milestone payments and royalties on any sales if a combination therapy is commercialised, the financial details of this deal remain undisclosed.
Initially, the duo’s collaboration will focus on a confidential rare cancer indication, which is an area where Dr Michal Tsur, PhD, co-founder and co-CEO of Remepy, says multi-disciplinary care can hold a lot of value. “Drug-software solutions are particularly rewarding in the context of rare disease, as patients often have limited access to care and information – which an app can help to provide,” Dr Tsur tells Medical Device Network.
In time, there is also room for this partnership to expand into additional therapeutic areas in the future, though these plans currently remain undisclosed.
By joining forces, Remepy and Merck KGaA hope to commercialise a drug-software combination as a singular product – a feat that no other player in the industry has yet achieved.
Differentiating drugs with digital technologies
As the pharma industry looks for new ways to improve patient outcomes, Tsur touts the integrated drug-software approach as a way to deliver the “best multidisciplinary treatment in a single prescription.”
By harnessing this dual-pronged method, companies also give themselves a chance to differentiate in increasingly crowded drug markets, Tsur adds, while allowing them to avoid the reimbursement hurdles associated with standalone digital therapies.
According to Tsur, the dual-pronged approach could also upgrade the treatment process, as physicians can prescribe a combination where both elements – the drug and the digital therapeutic – are clinically validated and have a known effect size when used in tandem. “In certain Hybrid Drug trials, we’ve seen that we can double the effect size of a standalone drug through multidisciplinary care, overcoming the drug ceiling effect,” she comments.
Navigating the regulatory landscape around digital therapies
When developing a drug-digital therapy concept, much like a traditional medicine, the digital therapeutic must undergo Phase I-III clinical trials to secure approval. However, Tsur explains that there are two regulatory options a company can pursue to get such a combination to market in the US.
“One is the traditional combination product pathway, where a drug-software is approved as a new, singular treatment,” she says. “Alternatively, companies can leverage the Prescription Drug Use-Related Software (PDURS) framework to secure a label expansion for an existing drug to the digital therapeutic effect,” Tsur adds.
While US regulators are becoming increasingly open to digital technologies in this context, the European Medicines Agency (EMA) is yet to introduce a policy like PDURS. However, Tsur believes that pressure will likely mount on European regulators to implement a policy around this when pharma companies launch products in the US.
If combination drug-software solutions were to take off, Tsur believes that companies will employ both regulatory approaches, as businesses with mature products will leverage PDURS to differentiate their drug from competitors, while younger companies may begin to bring combination products to the market.
Seeking success through the Hybrid Drug model
For an integrated drug-digital therapeutic to be successful, Tsur notes that the solution should be developed in an indication with unmet needs and strong disease heterogeneity, where a combination is most likely to have a meaningful effect size.
She also highlights the importance of choosing an indication where patients are already looking for non-pharmaceutical adjunct treatment options, as they are more likely to adhere to the treatment and derive its benefits.
From an efficacy standpoint, Tsur adds that mechanistic data should be gathered on how a digital therapeutic and a drug collectively impact both clinical scales, biomarkers and surrogate endpoints within a disease. This, she explains, will help prove how and why a combination therapy may eclipse the benefits of a medicine’s independent benefits, offering a stronger level of clinical validation.
