Huntexil pridopidine: Phase I data

A double-blind, multiple ascending-dose Phase I trial in 36 healthy volunteers showed that Huntexil led to dose-dependent QT prolongation that NeuroSearch said reached a "level of clinical concern" at both the twice-daily 67.5 and 90 mg dose groups compared to placebo. Additionally, Huntexil dose-dependently increased the incidence, severity and duration of adverse events, including nausea, headache, dizziness and vomiting. Furthermore, psychiatric signs and symptoms were reported at the twice-daily 90 mg dose, which was established as the MTD. NeuroSearch said the twice-daily 45 mg dose of Huntexil was well tolerated, although QT prolongation at the dose level was higher than that seen in previous clinical studies.

Based on the data, NeuroSearch said it will implement additional safety measures in its clinical programs evaluating twice-daily 45 mg Huntexil, including the North American Phase II Open-HART trial in 118 HD patients and its European compassionate use program. The company also said the planned Phase III program for Huntexil, which includes the PrimeHD trial, will be adjusted to reflect the new safety data, although final conclusions have not yet been made. NeuroSearch does not plan to start the PrimeHD trial until further financing is secured. In April, NeuroSearch said it is seeking a worldwide partnership for Huntexil after it was unable to secure a deal that would have excluded European rights to the product (see BioCentury, April 16). ...