Remepy Advances Hybridopa Toward Phase III After Positive Parkinson’s Disease Phase IIa Results

Remepy is preparing global Phase III development of Hybridopa, its investigational drug-software treatment for Parkinson’s disease, after a randomized Phase IIa study showed significant improvements in overall motor and non-motor symptoms. The company now plans to begin Phase III development in the fourth quarter of 2026, supported by new clinical and mechanistic evidence for combining levodopa with a personalized digital intervention.

Phase IIa Shows Clinical Benefit Beyond Standard Levodopa

The three-week Phase IIa trial enrolled 41 patients aged 45 to 80 years with Parkinson’s disease. Participants continued their existing levodopa regimen, ranging from 150 to 1,500 mg daily, and were randomized to receive either DopApp, the digital component of Hybridopa, or a placebo digital application.

Patients receiving Hybridopa achieved a mean 9.7-point reduction in MDS-UPDRS Parts I+II+III, compared with a 1.95-point reduction in the control group. The between-group difference was statistically significant (p=0.0005). In addition, 90% of participants receiving Hybridopa achieved at least a 5-point improvement on the combined MDS-UPDRS measure.

The findings were published in Brain Communications and included functional MRI analyses. Imaging showed strengthened connectivity in motor and limbic brain circuits, with these changes correlating with improvements in motor and mood-related outcomes. The results provide preliminary mechanistic evidence that the digital intervention may complement dopaminergic therapy through changes in neural connectivity.

Hybridopa Combines Levodopa with Personalized Digital Therapy

Hybridopa combines conventional pharmacological treatment with DopApp, a personalized digital protocol that delivers structured physical, cognitive, behavioral, and rehabilitative interventions. The approach reflects the multidisciplinary nature of Parkinson’s management, where pharmacological treatment is often supplemented by physiotherapy, speech therapy, occupational therapy, and other supportive interventions.

Remepy is attempting to integrate these components into a single therapeutic framework rather than treating digital interventions as a separate adjunct to drug therapy. The Phase IIa findings provide an early clinical test of whether this combination can produce benefits beyond unchanged levodopa treatment alone.

The results remain preliminary, however. The Phase IIa study was small and short, and the company has not reported Phase III efficacy or long-term safety data. Hybridopa remains investigational and is not approved by the FDA.

Phase III Will Test Reproducibility at Larger Scale

The planned global Phase III program will be the next major test of the Hybrid Drug concept. Its importance extends beyond confirming efficacy in Parkinson’s disease because it will determine whether the incremental clinical benefit observed from the digital component can be reproduced in a larger patient population.

Remepy co-CEOs Michal Tsur, PhD, and Or Shoval said the Phase III program will build on the company’s clinical results, peer-reviewed research, and development of a regulatory framework for drug-software combinations.

Merck Partnership Extends the Platform Beyond Parkinson’s

The company is also applying the Hybrid Drug model across other therapeutic areas. Remepy recently entered a strategic collaboration with Merck KGaA, Darmstadt, Germany, to develop Hybrid Drugs across multiple indications, beginning with rare tumors. The partnership reflects growing pharmaceutical interest in combining established pharmacological treatments with personalized software-based interventions.

Remepy says the platform could generate additional intellectual property, support lifecycle management, and differentiate existing or future medicines. Its development strategy therefore extends beyond Hybridopa to pharmaceutical co-development programs across multiple disease areas.

$36 Million Financing Funds Late-Stage Development

Remepy closed a $36 million Series A financing led by O.G. Venture Partners and M Ventures, the corporate venture arm of Merck KGaA. NFX, Vine Ventures, Qumra Capital, TechAviv, 97212 Ventures, Fresh Fund, PsyMed Ventures, Tadmor Group, Key1 Capital, and IT-Farm Corp. also participated.

The financing brings total capital raised to $62 million. Remepy will use the proceeds to fund global Phase III development of Hybridopa, expand its Hybrid Drug pipeline and platform, and accelerate pharmaceutical co-development partnerships.

The immediate clinical milestone is Phase III initiation in Q4 2026. The results of that program will determine whether the early efficacy and mechanistic signals from Hybridopa can translate into a clinically and regulatorily viable drug-software treatment for Parkinson’s disease.

Reference

Remepy Raises $36 Million Series A to Expand Its Hybrid Drug™ Pipeline Through Pharmaceutical Partnerships and Advance Phase III of Hybridopa™ for Parkinson’s Disease