Remepy Reports Phase 2a Results for Hybridopa, a Levodopa-and-App Combination

Remepy said on May 20 that a Phase 2a trial of Hybridopa, which pairs the standard Parkinson's disease drug levodopa with a smartphone-delivered digital program called DopApp, met its primary endpoint, according to the company's press release. The results were published in the journal Brain Communications in a paper titled "Neural correlates of Parkinson's improvements after combined digital-levodopa therapy: a pilot study".

The three-week, double-blind, placebo-controlled trial enrolled people aged 45 to 80 on stable levodopa doses. Participants used either DopApp or a placebo app. pharmaphorum reported the pilot had 42 subjects; the company's release gives N=41.

Company-reported results

According to Remepy, participants on Hybridopa had a mean reduction of 9.7 points on the combined MDS-UPDRS Parts I, II and III, compared with a 1.95-point reduction in the control group (p=0.0005). The company said 90% of Hybridopa participants improved by at least 5 points. pharmaphorum reported that the gains were driven by motor function and activities of daily living, with an improvement in depression symptoms as well.

Functional MRI scans taken before and after treatment showed strengthened connectivity in motor and limbic brain circuits that tracked the symptom improvements, the company said. It also reported that greater use of specific DopApp modules corresponded with improvements in matching clinical domains. These are results from a small, short pilot study as reported by the company and the study authors.

"The findings provide clinical validation that integrating pharmacologic treatment with adaptive digital protocols can amplify therapeutic response," said Or Shoval, Remepy's co-chief executive.

Phase 3 plans and the PDURS framework

Remepy said it plans to start a pivotal Phase 3 study in the second half of 2026 to evaluate efficacy and safety in a broader Parkinson's population. The company describes Hybridopa as a "Hybrid Drug", a combination of an immediate-release levodopa/carbidopa product with DopApp. The company says DopApp uses adaptive protocols that respond to each patient's performance, behaviour and clinical status, and delivers structured, multidisciplinary care at home.

pharmaphorum noted that the approach relies on the FDA's Prescription Drug Use-Related Software (PDURS) framework, set out in 2023 guidance, which covers apps and other software used alongside prescription medicines. Remepy said Hybridopa is an investigational product and has not been approved by the FDA or any other regulator.

"Hybridopa brings this integrated, personalized care into a single prescription, delivering daily, structured therapy at home, at scale," said Michal Tsur, the company's other co-chief executive.

pharmaphorum also reported that Remepy began an alliance with Merck KGaA the month before, focused first on hybrid drugs for rare tumours.