Zambon Announces Positive CHMP Opinion for Hopledo® (IPX203) for Adults with Parkinson’s Disease and Moderate to Severe Motor Fluctuations

Positive CHMP opinion is based on data from the Phase 3 RISE-PD trial, which demonstrated significantly more “Good ON” time with fewer daily doses compared with immediate-release levodopa/carbidopa More than one million people are living with Parkinson’s disease in the European Union, and over 80% experience motor fluctuations during the course of their disease, highlighting the need for additional treatment options Hopledo® contains a unique formulation combining immediate-release granules and extended-release pellets, providing both a rapid onset of action and a longer duration of effect, sustaining the levodopa therapeutic effect for a longer period of time If approved, Zambon expects to make Hopledo® progressively available to patients with Parkinson’s disease across Europe starting October 2026

Zambon today announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of a marketing authorization by the European Medicines Agency (EMA) for Hopledo® (modified-release levodopa/carbidopa) for the treatment of adult patients with Parkinson’s disease and moderate to severe motor fluctuations who have not been sufficiently stabilized with oral levodopa/DDC inhibitor-based treatment regimens.

CHMP recommendation is based on data from the Phase 3 RISE-PD trial, which compared Hopledo® with immediate release levodopa/carbidopa (LD/CD) formulation in patients with Parkinson’s disease and moderate to severe motor fluctuations. In the study, Hopledo® demonstrated a significant increase in Good ON time over immediate release LD/CD with fewer daily doses and a comparable safety profile¹.

Hopledo® is a first-in-class, oral, modified-release formulation of LD/CD designed for the treatment of fluctuations of Parkinson’s disease, the fastest growing neurological condition in the world according to the World Health Organization². Despite available oral treatments, there is a substantial need for new therapeutic options; during the course of the disease, more than 80% of patients with Parkinson’s disease experience motor fluctuations³. Hopledo® contains a unique formulation combining immediate-release granules and extended-release pellets, providing both a rapid onset of action and a longer duration of benefit, sustaining the levodopa therapeutic effect for a longer period of time. In 2024, Zambon entered into an exclusive licensing agreement with Amneal Pharmaceuticals for the commercialization of Hopledo® in the European Union, United Kingdom and Switzerland. Hopledo®, formerly known as IPX203, is already approved and marketed in the United States under the brand name CREXONT®, providing established regulatory and commercial experience as the therapy advances toward European approval.

“In Parkinson’s disease treatment is focused on maintaining consistent symptom control by prolonging levodopa benefit, reducing “Off” time, and simplifying dosing. Hopledo ability to extend “Good On” time with fewer daily doses offers a significant advancement in the management of motor symptoms and in achieving more stable and sustained therapeutic effects,” said Prof.Fabrizio Stocchi, Full Professor of Neurology at San Raffaele University in Rome and Head of Clinical Research in Movement Disorders and of the Parkinson’s Disease Research Centre.

“The CHMP positive opinion represents an important step towards expending access to this important therapy to patients in Europe. As the disease progresses, many patients require frequent dosing yet continue to face motor fluctuations. Hopledo addresses this unmet need by providing longer-lasting “Good On” time with fewer daily doses. This achievement underscores Zambon’s leadership in Parkinson’s disease and our unwavering commitment to more than one million people currently living with Parkinson’s disease in the EU,” said Mathias Knecht, M.D., Chief Medical Officer Innovative Therapies, Zambon.

Subject to European Commission approval, Zambon expects to begin the phased introduction of Hopledo® across European markets beginning in October 2026. The company is working closely with the healthcare authorities and other stakeholders to support timely patient access to this important new treatment option for patients across Europe who continue to experience motor fluctuations despite current oral therapies.

About the RISE-PD Phase 3 Trial
The multicenter, randomized, double-blind, double-dummy, active-controlled, parallel-group RISE-PD trial evaluated the efficacy and safety of IPX203 compared with IR LD/CD in the treatment of patients with PD with motor fluctuations. The primary endpoint of the trial assessed the change from baseline in “Good On” time in hours per day at the end of the double-blind treatment period (Week 20 or early termination). Secondary endpoints assessed the change from baseline in “Off” time in hours per day, proportion of patients who were either “much improved” or “very much improved” in Patients' Global Impression of Change (PGI-C) scores, change from baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III score, and the change from baseline in sum of MDS-UPDRS Parts II and III scores. The study included 506 patients who had received a PD diagnosis at age 40 or older.

About Zambon
For further information on Zambon please visit www.zambon.com

References
1. Hauser RA, et al. JAMA Neurol. 2023;80(10):1062-1069 and Supplementary materials
2. https://www.who.int/publications/i/item/9789240050983
3. Fabbri M, et al. Off-time Treatment Options for Parkinson’s Disease. Neurol Ther. 2023;12(2):391-424;
Demailly A, et al. Effectiveness of Continuous Dopaminergic Therapies in Parkinson’s Disease: A Review of L-DOPA Pharmacokinetics/ Pharmacodynamics. J Parkinsons Dis. 2024;14(5):925-939.

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