• Double-blind, placebo-controlled randomized study demonstrates significant improvements in motor and non-motor symptoms, as well as mechanistic proof in functional MRI imaging
• Phase III study planned for H2 2026 is the most advanced drug-software combination program in development
• The results are now published in Brain Communications

NEW YORK, May 20, 2026 /PRNewswire/ -- Remepy, a pioneer in Hybrid Drugs™, today announced that the Phase IIa clinical trial of Hybridopa™, a new Hybrid Drug for Parkinson's disease, met its primary endpoint, delivering statistically significant improvements across motor and non-motor outcomes in Parkinson's disease. The double-blind, placebo-controlled, randomized results demonstrate the ability of Hybridopa to enhance the clinical impact of standard levodopa therapy. The findings were published in Brain Communications in a paper titled "Neural correlates of Parkinson's improvements after combined digital-levodopa therapy: a pilot study". Hybrid Drugs are a new class of drugs that combine traditional pharmaceuticals with mechanistically proven app-delivered personalized digital interventions into a single prescription.

"These results represent an important milestone in Remepy's journey of bringing a first-in-class Hybrid Drug for Parkinson's disease to market, demonstrating how combining pharmacological drugs with personalized AI-driven digital protocols can improve the quality of life for people living with Parkinson's disease," said Or Shoval, Co-CEO of Remepy. "The findings provide clinical validation that integrating pharmacologic treatment with adaptive digital protocols can amplify therapeutic response. Building on these results, we are advancing Hybridopa toward a pivotal Phase III clinical program. The study will evaluate the therapy's efficacy and safety across a broader Parkinson's population. We are looking forward to initiating the Phase III study later this year, which will be the most advanced drug–software combination program in clinical development."

"Our recent meaningful results demonstrate something clinicians have long understood but have struggled to deliver consistently at scale," said Michal Tsur, PhD, Co-CEO of Remepy. "Decades of research show that Parkinson's care works best when dopaminergic therapy is combined with multidisciplinary interventions, including physical, cognitive, behavioral, speech and rehabilitative therapy. Hybridopa brings this integrated, personalized care into a single prescription, delivering daily, structured therapy at home, at scale."

The three-week, randomized, double-blind, placebo-controlled Phase IIa clinical trial (N=41) evaluated Hybridopa in patients aged 45–80 with Parkinson's disease. Participants were all on an unchanged dose of levodopa (ranging 150-1500mg daily), combined with DopApp™ or with a placebo digital application. The intervention consisted of a multi-modal daily digital protocol enabling structured, multidisciplinary care to be administered consistently in patients' home environments.

Key Clinical Highlights

Significant Motor and Functional Improvements - Participants who received Hybridopa achieved a mean reduction of 9.7 points on the MDS-UPDRS Parts I+II+III, compared to a 1.95-point reduction in the control group (p=0.0005), demonstrating a robust improvement beyond levodopa therapy alone.

High Responder Rates - 90% of Hybridopa participants achieved at least a reduction of 5-points in the MDS UPDRS Parts I+II+III), substantially exceeding response rates in the control arm.

Objective Neurobiological Findings - Advanced neuroimaging via functional MRI revealed strengthening of functional connectivity in motor and limbic brain circuits, correlating with improvements in both motor control and mood-related outcomes. These findings provide early mechanistic evidence that the digital component may reinforce dopaminergic treatment through targeted neuroplasticity.

Engagement-Linked Outcomes - Greater engagement with specific DopApp modules corresponded with domain-specific clinical improvements, highlighting the importance of personalized digital interaction in driving therapeutic outcomes.

Diverse Patient Population - The study population included patients with diverse disease profiles, yet the integrated therapy demonstrated consistent benefit across the cohort, suggesting the potential to impact a broad Parkinson's population.

"Parkinson's disease varies widely from patient to patient, requiring treatment strategies that can match its complexity. Hybridopa introduces a new personalized therapeutic approach, integrating established medications with personalized digital protocols to better support outcomes in everyday life," said Prof. Amir Amedi, Chief Science Officer at Remepy, and lead researcher in the published study. "The magnitude of improvement in MDS-UPDRS, combined with correlated brain connectivity changes in some of the basal ganglia and cortical brain areas most affected by Parkinson's disease, is both striking and scientifically compelling. This integrated approach represents an important step forward in how Parkinson's disease, and other conditions can be treated."

About Hybrid Drugs™

Hybrid Drugs are an innovative class of drugs that combine pharmacological drugs with personalized digital interventions. Industry research increasingly shows that the most effective care for many diseases is multidisciplinary and integrative, combining medication with behavioral, cognitive, and therapeutic interventions. Hybrid Drugs integrate these evidence-based motor, physical, and cognitive interventions together with medication to improve clinical outcomes.

Hybrid Drugs are gaining momentum driven by a combination of recent developments. Regulatory frameworks are rapidly evolving, with initiatives like FDA PDURS and emerging Drug–SaMD pathway^[1] enabling the integration of software directly into pharmaceutical products. At the same time, healthcare systems are embracing multidisciplinary, integrated care models, while advances in AI make it possible to deliver personalized therapeutic interventions at scale. Together, these shifts unlock a new category of medicine, one that translates the value of digital health into the proven economic model of pharma, aligning innovation with established pathways of development, approval, and reimbursement.

About Hybridopa™

Hybridopa™ combines immediate-release levodopa/carbidopa with DopApp™, a digital protocol delivered through a mobile application. Hybridopa uses adaptive protocols that respond to patient performance, behavior, and clinical status to enhance both motor and non-motor outcomes in Parkinson's disease. Soon moving into its Phase III global clinical trial, Hybridopa is an investigational product and has not yet been approved by the FDA or any regulatory authority.

About Parkinson's Disease

Parkinson's disease is a progressive neurological condition that primarily affects movement due to the gradual loss of dopamine-producing neurons in the brain. Common symptoms include tremors, stiffness, slowed movement (bradykinesia), and impaired balance and coordination, alongside non-motor symptoms such as sleep disturbances, depression, and cognitive changes.^[2]

About Remepy

Remepy is a clinical-stage biotechnology company pioneering Hybrid Drugs™ - a therapeutic category that integrates pharmaceutical treatments with personalized digital protocols to improve clinical outcomes. By combining established pharmacologic agents with structured motor, cognitive, and behavioral interventions delivered through regulated software, Remepy aims to unlock new therapeutic potential for both existing and novel medicines while enabling more personalized care at scale. The company also partners with pharma companies to bring Hybrid Drugs to market by enhancing existing drug labels and driving innovation across therapeutic areas.

For media inquiries, please contact:

Tsipi Haitovsky
Global Media Liaison
Remepy
Press@remepy.com

[1] https://www.fda.gov/regulatory-information/search-fda-guidance-documents/regulatory-considerations-prescription-drug-use-related-software
https://www.fda.gov/medical-devices/digital-health-center-excellence/software-medical-device-samd

[2] https://www.parkinson.org/about-us/news/economic-burden-2024-report

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SOURCE Remepy