Multiple sclerosis drug MIS416 benefits from compassionate use in progressive MS(18/06/14)

Innate Immunotherapeutics drug candidate for secondary progressive multiple sclerosis continues to benefit patients being treated on compassionate grounds in New Zealand.

It is also providing the company with strong data and results from use of MIS416 which show the majority of patients in the program are benefitting from its use.

Of the 24 patients using drug candidate MIS416, 15 were previously subjects in the company’s Phase 1B/2A trial and had requested ongoing access to the drug after completion of the trial.

Out of the 24 patients, 18 have SPMS while 6 have the rarer primary progressive form of multiple sclerosis.

The median time on treatment for all compassionate use patients is now approaching 24 months and these patients have received an average of 52 doses of MIS416.

While a compassionate use program cannot be used to prove the safety or efficacy of a drug, important information can still be collected from the doctors involved and the patients who are being treated in this manner.

The latest results from ongoing regular safety blood tests continue to suggest that patients can receive weekly or fortnightly injections of MIS416 on a long-term and continuous basis without experiencing significant dose intolerance or cumulative toxicity.

Analysis of the recently updated quarterly results of patient self-reported health status outcomes show that the majority of patients continue to experience significant and sustained reductions in pain and fatigue.

Immunotherapeutics continues to recruit the Australian sites required to conduct its Phase 2B efficacy trial.

This will focus on accessing the efficacy of MIS416 by using several clinical measures of neuromuscular function, backed by patient reported outcomes of treatment effect.

Secondary progressive multiple sclerosis affects walking, hand, eye sight and cognitive functions, and these disabilities will be measured regularly during the trial.

Analysis

While the use of the MIS416 to treat secondary progressive multiple sclerosis patients on compassionate grounds in New Zealand cannot be used to prove the safety or efficacy of a drug, the ongoing patient and doctor reports, collated by the company, are indicative of its beneficial effects.

This is especially true given that the reported observations including that sustained improvements in SPMS related patient symptoms is unusual and that some reported improvements exceed margins of “normal” variability in the literature.

The results from the program are such that it provides a means to better recruit for its Phase 2B efficacy trial in this patient population. 

Source: proactive investors Australia Copyright © proactiveinvestors.com.au 2014 (18/06/14)