Intec Pharma has again tapped the Michael J. Fox Foundation for Parkinson’s Research for development of its Parkinson’s med AP-CD/LD. This time on the collaboration agenda is patient recruitment for phase 3 trials.
Levodopa is currently the most widely used and most effective therapy for Parkinson’s disease, and Intec Pharma’s ambition is to improve the unstable benefits inherent with the current treatment. The idea of Intec’s AP-CD/LD, which includes levodopa and carbidopa, is to utilize the company’s Accordion Pill gastric retention drug delivery system to limit the body motor complications many Parkinson’s patients experience between levodopa doses due to the drug’s short duration of effect.
The company initiated the phase 3 trial with enlistment of its first patient in April, and the intention was to enroll 460 volunteers in the U.S., Europe and the company’s home country, Israel; but in November, it cut back its original plan to a smaller sample size of 328 patients. Intec Pharma’s CEO Zeev Weiss said at the time that the reduction in sample size should shorten study completion timelines and reduce overall costs.
The primary endpoint was left unchanged as measuring the change in percentage of the patients’ daily “wearing off time”—debilitating periods of decreased body motor functions—when they’re awake based on Hauser home diaries. The company expects to wrap up the enrollment process by the end of 2017.
Now, adding to Intec’s effort to gather the newly revised desired number of volunteers for this round of study is help from MJFF, the largest nonprofit sponsor of Parkinson’s research, whose “long-term experience in the field and close connections with the patient community are especially valuable,” Weiss said in a statement. The foundation previously supported the company’s preclinical study of AP-CD/LD with a $705,000 grant.
In the phase 2 trial of AP-CD/LD in 60 patients, those who received the Intec’s version of carbidopa and levodopa combo at 50mg/375mg and 50mg/500mg twice daily for three weeks showed reduction in daily off time by 44% and 45% respectively. If the phase 3 trial could demonstrate similar results, AP-CD/LD could potentially become a replacement levodopa treatment for Parkinson’s.