Avigen Initiates U.S. Clinical Development for AV411

Avigen announced it received approval from the FDA to proceed with clinical development of AV411, a treatment for chronic neurological conditions.

The initial U.S. clinical trial for AV411 (ibudilast), which is treated as a new chemical entity in the U.S., will be a Phase I maximum tolerated dose study that is designed to build on data from Avigen’s Phase I and exploratory Phase IIa studies in Australia, Avigen said.

The trial will assess the safety and tolerability of AV411. It is also intended to assess the effect of food on AV411 pharmacokinetics and tolerability, the company added.

The study may involve the dosing of a maximum of 48 subjects and is intended to establish the maximum tolerated dose and the effect of a standard meal on the tolerability and pharmacokinetics of AV411 when compared with the same subjects under fasting conditions, the company said.