Dive Brief:
- Intec Pharma is teaming up with the Michael J. Fox Foundation to help recruit and retain patients in its Phase 3 clinical trial of an oral drug for people with advanced Parkinson's disease.
- The trial, which involves Intec Pharma's lead product candidate, the Accordion Pill Carbidopa/Levodopa (AP-CD/LD), began enrolling participants in April 2016, the Israel-based biopharmaceutical company said.
- The Foundation, which is the largest nonprofit funder of Parkinson's research, aims to speed development of new therapies. It previously gave a $705,000 grant to Intec Pharma to support a preclinical study of AP-CD/LD.
Dive Insight:
On Nov. 7, Intec Pharma announced that it had amended its protocol for the clinical trial of AP-CD/LD to reflect input from "key opinion leaders" and biostatisticians specializing in Parkinson's disease. As a result, the study's patient size was reduced from 460 patients to 328 patients, the company said.
Intec Pharma stressed that the smaller patient cohort "does not alter the objectives, endpoints or statistical power (90%)" of the global trial. The company said its amendment had been reviewed by the Food and Drug Administration, which had no comments on the proposed changes.
Intec Pharma CEO Zeev Weiss said the reduction in sample size is expected to "shorten study completion timelines and reduce overall costs," and the company expects to complete patient enrollment in the fourth quarter of 2017.
Intec Pharma's Accordian Pill platform is an oral drug delivery system aims to improve existing drugs through efficient gastric retention. The company is using the same Accordion Pill platform in its ongoing clinical trials of insomnia and ulcer treatments.
Catherine Kopil, director of the foundation's research partnerships, said in a statement that leveraging the foundation's tools and best practices to encourage people to enroll in Intec Pharma's AP-CD/LD study will accelerate testing of the potential therapy. She said more options to treat motor symptoms of Parkinson's would have a significant impact on millions of people living with the disease.
Kopil told BioPharma Dive that research volunteers are vital partners in developing and testing new treatments, "but unfortunately many trials face delays due to slow recruitment of participants." She said the Foundation works with various study sponsors and sites on recruitment and retention strategies to advance studies of potential therapies, and also has developed an online matching tool, Fox Trial Finder, to connect interested volunteers with recruiting studies. The tool has 62,000-plus users and listings for nearly 650 Parkinsonism studies.