NeuroDerm Ltd., a clinical stage pharmaceutical company developing drugs for central nervous system (CNS) disorders, says has initiated enrollment of Parkinson’s disease (PD) patients in a Phase III efficacy trial (trial 007, named the “iNDiGO” trial) of ND0612L, the company’s low-dose continuous, subcutaneously delivered levodopa/carbidopa (LD/CD) liquid formulation.
Background
NeuroDerm’s Parkinson disease treatment is a past visitor to our pages, mainly by virtue of the fact that it comprises a pharmaceutical compound (so-called ND0612L), administered subcutaneously using a delivery device. Last time we reported on progress, it was late 2015 and the company was launching into its phase III trial. Now starts iNDiGO, a phase III, 16-week, international, multicenter, randomized, double-blind, placebo controlled, parallel group study designed to compare the efficacy, safety and tolerability of continuous subcutaneous infusion of adjunct ND0612L therapy with oral standard-of-care and placebo in patients who suffer from motor fluctuations despite optimized standard-of-care therapy. Patients will be randomized to receive either continuous subcutaneous infusion of ND0612L or a placebo replaced every 24 hours during the 16-week treatment period. The primary endpoint is the change from baseline to week 16 in the mean percentage of “OFF” time, defined as periods of motor fluctuations that result in decreased mobility during waking hours, based on patients’ home diary assessments.
The good news for NeuroDerm is that while the original trial design anticipated enrolling 200-240 patients, the company has been able to reduce this number to 150 patients following sample size calculations using the expected treatment effect and variability as well as those observed in a previous trial (trial 003). In this previous phase II randomized, double-blind, placebo controlled trial, adjunct ND0612L therapy was shown to maintain high trough LD plasma levels and to reduce “OFF” time by two hours compared to the control arm – oral standard-of-care with placebo. The iNDiGO trial is anticipated to conclude in 2017.
Company comments
“The initiation of the iNDiGO trial marks another important milestone in the development of ND0612L as part of our Parkinson’s disease treatment pipeline,” said Oded S. Lieberman, PhD, CEO of NeuroDerm. “The current reduction in the number of patients to be enrolled in our iNDiGO trial, following streamlining this past November of our clinical development program from two phase III trials to one trial, should further simplify and facilitate our clinical development program for ND0612L. We believe that ND0612L holds tremendous potential in providing PD patients with a simple, continuous levodopa delivery treatment option that does not require surgery. ND0612L is further being developed for future delivery through a small patch pump that should offer a new level of therapy convenience. We are committed to making this promising candidate available to patients as quickly as possible and are pleased to have this trial underway.”
Source: Globe Newswire