Remepy is taking its hybrid Parkinson’s therapy, Hybridopa, to Phase III, after the blended app-drug approach offered motor and non-motor outcome improvements in a mid-stage pilot study.
In the three-week Phase IIa trial, Remepy randomised 41 patients aged 45-80 with Parkinson’s disease to receive either Hybridopa, which combines standard of care (SoC) therapy, levodopa and a digital app, or treatment with a placebo app plus levodopa.
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During the study, patients treated with Hybridopa experienced a 9.7-point mean reduction on a scoring system used to measure Parkinson’s symptoms – offering significant improvements over the 1.95-point decrease experienced by the placebo group. According to a paper on the study published in Brain Communications, improvements were primarily driven by an uptick in activities of daily living and motor function, as well as a drop in depressive symptoms.
Alongside its impact on clinical outcomes, treatment with Hybridopa appears to have a physical impact on the brain, as advanced MRI-based neuroimaging reveals that those receiving the combination therapy experienced strengthened connectivity between the motor and limbic circuits of the brain. According to Remepy, this provides early evidence that the hybrid drug-plus-app approach may offer an additive benefit to dopaminergic therapies by promoting targeted neuroplasticity.
Following the positive outcomes of the mid-stage study, Remepy is gearing up to initiate a Phase III study on Hybridopa later in 2026, which the company’s co-CEO, Or Shoval, says will make it “the most advanced drug-software combination” currently in clinical development.
Before these results debuted, Remepy inked a collaboration deal with German pharmaceutical giant Merck KGaA to develop an app and pharmaceutical-based combination approaches, which co-CEO, Dr Michal Tsur, says can sidestep reimbursement hurdles linked to individually approved digital therapies.
Ending the treatment drought in Parkinson’s
The outcomes of Remepy’s Phase IIa study on Hybridopa come as there has been a notable drought in new treatment options, with levodopa remaining as the gold standard treatment since its approval more than 50 years ago.
While doctors are increasingly prescribing combination treatment approaches that harness levodopa and other therapeutic options like cognitive behavioural, speech or physical therapy, Tsur notes that it has been challenging to deliver this consistently at scale.
According to Tsur, Hybridopa would facilitate “integrated, personalised care into a single prescription – delivering daily, structured therapy at home at scale”.
Outside of the digital therapeutic space, several pharma and biotech companies are progressing their Parkinson’s drugs through late-stage clinical trials. This includes Aspen Neuroscience, which is taking its stem cell therapy to a pivotal trial following an efficacy win in the Phase Ia/II ASPIRO study (NCT06344026).
In a previous conversation with Clinical Trials Arena, David Dexter, head of research at Parkinson’s UK, noted that clinical research on Parkinson’s disease is at a “pivotal point”, but funding barriers and outdated clinical trial approaches remain barriers to innovation.
