Australia’s Innate Immunotherapeutics confirmed that its Phase 2b clinical trial evaluating the drug MIS416 in patients with secondary progressive multiple sclerosis (SPMS) will wrap up by April 30, as scheduled, and data is expected to be release in the fall.
MIS416 is a biologically derived new immune modulator that can target both the regulatory and defensive functions of the innate immune system. The microparticle is designed to target myeloid cells (a subset of innate immune cells not currently targeted by any other drug), and can play a key role inside the brain of a patient with SPMS by decreasing inflammation, helping clear myelin debris and enhancing tissue repair processes.
The current Phase 2b trial (NCT02228213) is an exploratory, double-blind, randomized, placebo-controlled study assessing the safety and effectiveness of MIS416 when administered once a week over 12 months.
The trial enrolled 93 SPMS patients between late 2014 and April 2016. The final 16 are set to complete the study over the next eight weeks, with the final dose administered on April 19. The study raised no safety concerns and its independent Data Safety Monitoring Board met on three occasions without any expression of concerns regarding the trial’s outcomes, the company reported.
Following the final patient visit, Innate expects it to take up to four months to complete the entry, monitoring and analysis of the data generated by the study. The final report should be released in August or September, though initial top-line data might be available before then.
“The participants in this study endure a wide range of MS-related debilitating symptoms and we deeply appreciate the commitment and fortitude with which so many of them have adhered to the requirements of what is an intensive course of treatment and tests over a 52 week period,” Innate CEO’s, Simon Wilkinson, said in a press release.
Most patients who have completed the trial remain keenly interested in this therapy and have requested post-study access to MIS416. Innate is now working with these patients’ healthcare providers to make the medication available whenever possible, it said in the release.