Hybridopa (immediate-release levodopa/carbidopa) / Remepy - LARVOL DELTA

EAGLE: Protocol for a Phase 3 Study to Evaluate the Efficacy and Safety of Two Mobile Applications Combined with Immediate-Release CD/LD for the Management of Idiopathic Parkinson’s Disease (MDS Congress 2026) - "Objective: To evaluate the efficacy and safety of Hybridopa A and Hybridopa B, combination products of immediate-release carbidopa/levodopa (IR CD/LD) and therapeutic mobile applications, in adults with idiopathic Parkinson’s disease (PD) on a stable dose of CD/LD without clinically significant motor fluctuations... The EAGLE study is designed to generate confirmatory evidence for a hybrid therapeutic approach that could broaden treatment options and influence future standards for comprehensive symptom management in Parkinson’s disease"

Clinical • P3 data • CNS Disorders • Depression • Movement Disorders • Parkinson's Disease

Early clinical experience with IPX203 in Parkinson's disease with motor fluctuations. (PubMed, J Neural Transm (Vienna)) - "Phase 2 studies demonstrated rapid levodopa absorption and prolonged plasma exposure, while the phase 3 RISE-PD trial showed significantly greater Good ON time with fewer daily doses compared with optimized immediate-release levodopa/carbidopa. Three representative patient vignettes illustrate common clinical scenarios and practical approaches to treatment optimization. IPX203 provides a novel oral levodopa/carbidopa delivery strategy that combines rapid onset with prolonged duration of benefit. Clinical trial data and early clinical experience support its use as an effective option for patients with PD experiencing motor fluctuations and highlight the importance of individualized treatment optimization to maximize therapeutic benefit."

Journal • Review • CNS Disorders • Movement Disorders • Parkinson's Disease

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 (Remepy Press Release) - "The proceeds will accelerate the Company’s pharmaceutical co-development partnerships and expansion of its Hybrid Drug pipeline and platform and fund the global Phase III clinical development of Hybridopa, Remepy’s lead program for Parkinson’s disease that will commence in Q4 2026. This funding brings the total capital raised by the Company to $62 million."

Financing • New P3 trial • Parkinson's Disease

Population pharmacokinetic analyses comparing immediate-release levodopa/carbidopa, controlled-release levodopa/carbidopa, and IPX203. Findings from a phase 1 study in healthy volunteers. (PubMed, J Neural Transm (Vienna)) - "Model-based simulations of commonly used dosing regimens suggested that IPX203 administered every 6 h achieved the most stable levodopa concentrations. These findings indicate that IPX203 provides a distinct exposure profile characterized by rapid onset and sustained levodopa exposure driven by controlled absorption."

Journal • P1 data • PK/PD data • CNS Disorders • Movement Disorders • Parkinson's Disease

Remepy Reports Strong Clinical Phase IIa Results for Hybridopa, a First-in-Class Hybrid Drug for Parkinson’s Disease (PRNewswire) - "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....Phase III study planned for H2 2026 is the most advanced drug-software combination program in development."

New P3 trial • P2a data • Parkinson's Disease