Innate Immunotherapeutics has announced positive interim data from the Phase 1/2 trial evaluating the safety, tolerability and pharmacodynamics of intravenously administered MIS416 in patients with chronic progressive multiple sclerosis (MS).
The open-label study results revealed that MIS416, the main product from Innate's proprietary immune modulating microparticle technology, was well tolerated and a clinical dose for further evaluation was identified.
During the dose confirmation part of the trial, eight of ten patients with secondary progressive MS treated with MIS416 for 12 weeks, showed some improvement in their MS-related signs and symptoms.
The study's co-principal investigator, Tim Anderson, said the preliminary data indicate that MIS416 was safe and well tolerated, and the MS-related clinical status assessment tools used during the study also indicate that the trial agent may have had some positive effects for many of the treated patients.
"For example, 50% of the study subjects showed some improvement in EDSS scores over the relatively short 12-week duration of the trial," Anderson added.
The safety and tolerability, including maximum tolerated dose and recommended Phase 2 dose, of weekly intravenously administered MIS416, as well as the pharmacodynamics of the agent, comprised the primary endpoints of the study.
Any changes in MS clinical status occurring during the 12-week dose confirmation phase of the study were the secondary endpoints.
The company anticipates completing the Phase 1/2 study and announcing final results in late 2012.
Innate CEO Simon Wilkinson said the company intends to investigate the sustainability of the improvements in clinical status seen in the study through a 12-month Phase 2B study, which should begin enrolment in early 2013.
"We plan to conduct this study in Australia, to take advantage of the country's greater patient availability, the availability of excellent principal investigators and the financial support offered by the Australian government," Wilkinson added.