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Thursday, January 16, 2014 12:34 PM | Tony Miles Volg link

Australian drug developer raises $10 million for new SPMS therapy(15/01/14)


It is estimated that more than one thousand Multiple Sclerosis-related drugs are currently in the research and development pipeline. While a large percentage of the world’s MS drugs and therapies tend to be aimed at curtailing the symptoms of relapsing-remitting Multiple Sclerosis — among the more common first stages of the disease — there are a few drug developers who are working on therapies that target Secondary Progressive Multiple Sclerosis, or SPMS for short. Australian Innate Immunotherapeutics is one of them.

In mid-December, the Sydney-based biotech firm raised an impressive $10 million in funding through an Initial Public Offering (IPO), the majority of which will be used to plan and implement a new clinical trial for its lead experimental therapy for SPMS, MIS416. The success of the IPO came about from existing international shareholders in the company, as well as new Australian institutional investors, all of whom have reacted positively to preliminary test results involving the SPMS drug. Innate also managed to convert its debt with prior debt holders, who also participated in the IPO. As a result, the company currently has no remaining loan obligations.

MIS416 is the biologically derived microparticle at the heart of Innate’s SPMS therapy. The particle is able to “target both the regulatory functions and the defensive (pathogenic) functions of the innate immune system,” according to a company press release. Because “the innate immune system is the body’s first line of defense against external disease causing agents (pathogens) such as bacteria and viruses, and internally caused diseases such as cancer,” MIS416's ability to focus an SPMS patient’s immune system response to the disease is a promising, new treatment concept that sets it apart from traditional Multiple Sclerosis therapies. The company also believes that MIS416 can be used to treat other diseases and disorders that affect the immune system, such type 1 diabetes, inflammatory diseases such as rheumatoid arthritis, and inflammatory bowel disease.

Thus far, the company has already completed Phase 1B/2A trials in New Zealand for the experimental drug, which revealed no safety concerns and “showed clear signs of positive effect” in participants after three months of therapy. Even though MIS416 is still in its experimental phase, Innate has designated the drug for use in a small group of SPMS participants who are able to receive the drug based on New Zealand’s “compassionate grounds” laws. During the 5-year exemption granted by the New Zealand law, 14 of the 17 SPMS participants “have reported significant improvements in a range of their disease related disabilities.”

One Innate’s Phase 2B trial is completed in late 2015, the company’s is planning to align with pharmaceutical companies who are well positioned to commercialize a drug for SPMS, which bodes well considering the Multiple Sclerosis market is estimated to be worth $11 billion annually.

“The IPO has provided the Company with the funds to finance a placebo controlled Phase 2B efficacy study of MIS416 in Australian patients with SPMS,” said Simon Wilkinson, CEO of Innate Immunotherapeutics. “These patients do not have access to effective long-term treatments and so with the close of the IPO we can now move rapidly to get the efficacy trial underway,” he added.

Source: BioNews Texas Copywrite BioNews Services, LLC 2014 (15/01/14)