Innate Therapeutics initiates MIS416 Phase 2a clinical study in patients with progressive multiple sclerosis

Innate Therapeutics today announced that the company has begun treating patients in a Phase 2a clinical study of its lead molecule, MIS416, in patients with progressive multiple sclerosis (MS).

“MIS416 is believed to work through a combination of mechanisms involving the down regulation of chronic inflammation, reduction of autoimmune factors, and the repair of damaged tissue”

"MIS416 is believed to work through a combination of mechanisms involving the down regulation of chronic inflammation, reduction of autoimmune factors, and the repair of damaged tissue," said Simon Wilkinson, Innate Therapeutics chief executive officer. "MS is the most common progressive and disabling neurological condition in young adults. More than half of the patients initially diagnosed with the relapsing-remitting form of the disease go on to develop progressive MS, for which there currently are no approved therapies. Thus, there is an obvious and important unmet medical need for new treatments."

Mr. Wilkinson noted that Innate Therapeutics had chosen MS as its initial disease target because of encouraging results of testing of MIS416 in a small number of New Zealand patients who had early access (under the NZ Medicines Act) to the drug on compassionate grounds, and because of US$550,000 funding received from the US not-for-profit, Fast Forward. Established by the United States National Multiple Sclerosis Society and part funded by EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany, Fast Forward is committed to providing support to accelerate the development of research discoveries into new or improved therapies for people with MS. Innate has additionally received NZ$600,000 in support of the development of MIS416 from the NZ Foundation for Research, Science and Technology (FRST).

The study, to be conducted at the Primorus clinical trial unit in Christchurch, New Zealand, will enroll a total of 24-30 patients. The initial stage of the trial, involving the first 12-18 patients, will examine the safety, tolerability and pharmacokinetics of intravenously administered MIS416 to determine a recommended therapeutic dose and dosing interval for the confirmatory portion of the trial. The dose confirmation portion of the study will treat patients weekly at the recommended dose level for a period of six months. Besides safety and tolerability, the end point for this confirmatory portion of the study will be to document any changes in MS clinical status, as determined by several standard MS scales for clinical evaluation, as well as frequency of relapses and signs of clinical activity on serial brain MRI scans. Innate Therapeutics expects to complete the study around the end of 2011.

Innate Therapeutics is additionally conducting preclinical studies with MIS416 in other applications, including as a potential co-therapy with other treatments for cancer, and in the treatment of infectious diseases.