Amneal to Present Results From the Pivotal Phase 3 RISE-PD Clinical Trial of IPX-203 at the 2022 American Academy of Neurology Annual Meeting

Rhea-AI Summary

Amneal Pharmaceuticals (NYSE: AMRX) has announced the presentation of topline results from its pivotal Phase 3 RISE-PD trial for IPX-203, a novel CD/LD formulation for Parkinson's disease, at the American Academy of Neurology Annual Meeting from April 2-7, 2022, in Seattle, WA. The trial demonstrated significant improvement in "Good On" time per dose, indicating potential benefits in symptom control. A New Drug Application is planned for submission in Q2 2022. The study involved 506 patients across 105 sites in the U.S. and Europe, showcasing Amneal's commitment to advancing Parkinson's treatments.

Positive

• Topline results from the Phase 3 RISE-PD trial showed statistically significant improvement in "Good On" time.
• IPX-203 provided an increase of 1.55 hours of "Good On" time per dose compared to immediate release CD/LD, a 70% improvement.
• Plan to submit a New Drug Application for IPX-203 in Q2 2022.

Negative

• None.

-        First presentation at a medical meeting of topline results and post hoc analysis

-        Positive topline results were previously announced in August 2021

BRIDGEWATER, N.J.--(BUSINESS WIRE)-- Amneal Pharmaceuticals, Inc. (NYSE: AMRX) today announced that results from the pivotal Phase 3 RISE-PD clinical trial evaluating the novel investigational extended-release CD/LD formulation, IPX-203, in Parkinson’s disease patients with motor fluctuations, will be presented at the 2022 American Academy of Neurology (AAN) Annual Meeting, April 2-7, in Seattle, WA.

The data are being presented for the first time at AAN and are consistent with the positive topline results announced last year. Amneal plans to submit a New Drug Application for IPX-203 in the second quarter of 2022. Amneal’s abstracts at AAN will include:

A Phase 3 Trial of IPX-203 vs. Immediate Release CD/LD in Parkinson’s Disease Patients with Motor Fluctuations (RISE-PD); Hauser, R. et al.

Session S16: Movement Disorders: PD Biomarkers and Clinical Trials; Monday, April 4; 5:18 PM PT

• Lead investigator Robert A. Hauser, M.D., will present the topline results of the Phase 3 RISE-PD clinical trial as part of a scientific platform session at the AAN Annual Meeting in Seattle, WA.
• In the trial, IPX-203 showed statistically significant improvement in “Good On” time compared to immediate release CD/LD, when dosed on average three times a day compared to five times a day for immediate release CD/LD.

Duration of Benefit Per Dose: Post Hoc Analysis of “Good On” Time Per Dose for IPX-203 vs. Immediate Release CD/LD in the RISE-PD Phase 3 Trial; Hauser, R. et al.

Session P10: Movement Disorders: Trials 2; Tuesday, April 5; 8:00 – 9:00 AM PT

• Post hoc analysis of Least Squares Mean difference at end of study (week 20) showed that IPX-203 provided 1.55 more hours of “Good On” time per dose versus immediate release CD/LD, representing a 70% increase.

“The findings from a post hoc analysis of the RISE-PD trial indicated that IPX-203 may offer patients more ‘Good On’ time per dose, compared to immediate-release CD/LD. Increasing the amount of ‘Good On’ time, if confirmed, can reduce disruptions caused by troublesome dyskinesia and provide more consistent symptom control throughout the day,” said Robert A. Hauser, M.D., Professor of Neurology at the University of South Florida and Director of the Parkinson's Disease and Movement Disorders Center.

“We are so pleased to be back in-person at the 2022 AAN Annual Meeting where we will be presenting data from the Phase 3 clinical trial on IPX-203,” said Richard D’Souza, PhD, Senior Vice President, R&D for Amneal Specialty. “Amneal’s presentations at AAN underscore our commitment to advancing research and treatment for patients living with Parkinson’s disease and the communities that support them. We are encouraged by the trial findings, as they indicate that IPX-203 could offer patients and the physicians that treat them another safe and effective treatment option with reduced dose frequency.”

The 2022 AAN abstracts are available here.

About the Pivotal Phase 3 RISE-PD Trial

The multicenter, randomized, double-blind, double-dummy, active-controlled, parallel-group RISE-PD trial evaluated the efficacy and safety of IPX-203 CD/LD extended-release capsules compared with immediate-release CD/LD in the treatment of patients with PD who have motor fluctuations.

The trial consisted of a 3-week, open-label immediate-release CD/LD dose adjustment period and a 4-week, open-label period for conversion to IPX-203. This was followed by a 13-week double-blind treatment period in which patients were randomized 1:1 to receive either IPX-203 (with matching immediate-release CD/LD placebo) or immediate-release CD/LD (with matching IPX-203 placebo). Baseline for all endpoints was Week 7 (Visit 4), which occurred pre-randomization.

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). “Good On” time is defined as the sum of “On” time without dyskinesia and “On” time with non-troublesome dyskinesia. 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 trial was conducted at 105 clinical sites in the U.S. and European countries, including Czechia, France, Germany, Italy, Poland, Spain and the United Kingdom. The study randomized 506 patients who had received a PD diagnosis at age 40 or older. The study design was reviewed by the FDA and conducted pursuant to a Special Protocol Assessment. A nine-month safety extension study is ongoing.

About IPX-203

IPX-203 is a novel, oral formulation of CD/LD extended-release capsules designed for patients with Parkinson’s disease who have motor fluctuations. IPX-203 contains immediate-release granules and extended-release coated beads. The IR granules consist of CD and LD, with a disintegrant polymer to allow for rapid dissolution. The ER beads consist of LD, coated with a controlled-release (CR) polymer to allow for slow release of the drug, a mucoadhesive polymer to keep the granules anchored to the area of absorption longer, and an enteric coating to prevent the granules from disintegrating prematurely in the stomach. This formulation is distinct from RYTARY^® (carbidopa/levodopa) extended-release capsules, Amneal’s extended-release CD/LD treatment for PD approved by the U.S. FDA in 2015.

About Amneal

Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, NJ, is a fully integrated essential medicines company. We make healthy possible through the development, manufacturing, and distribution of generic and specialty pharmaceuticals, primarily within the United States. The Company has a diverse portfolio of approximately 250 products in its Generics segment and is expanding across a broad range of complex products and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceutical products focused primarily on central nervous system and endocrine disorders, with a pipeline focused on unmet needs. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more, please visit www.amneal.com.

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Investor Contact

Anthony DiMeo

Senior Director, Investor Relations

anthony.dimeo@amneal.com

Media Contact

Ana Fullmer

Group Director, Media and Engagement, Real Chemistry

afullmer@realchemistry.com

Amneal Medical Affairs

888-990-AMRX (2679)

askamrx@amneal.com

Source: Amneal Pharmaceuticals, Inc.

FAQ

What were the results of the Phase 3 RISE-PD trial for AMRX's IPX-203?

The trial showed significant improvement in "Good On" time per dose compared to immediate release CD/LD.

When will the results of the RISE-PD trial be presented?

The results will be presented at the American Academy of Neurology Annual Meeting from April 2-7, 2022.

What is the anticipated timeline for the New Drug Application for IPX-203?

Amneal plans to submit the New Drug Application for IPX-203 in the second quarter of 2022.

What is the significance of "Good On" time in Parkinson’s disease treatment?

"Good On" time refers to the duration when patients experience symptom control without troublesome dyskinesia, crucial for improving daily living.