NZ Biotech to test Multiple Sclerosis treatment

NZ Biotech to Test Promising Therapeutic for Multiple Sclerosis Funding Being Provided by NZ Govt & US Not-for-Profit

A clinical trial to test a promising new multiple sclerosis therapeutic gets underway in Christchurch later this month.

The therapeutic, developed by Auckland biopharmaceutical company Innate Therapeutics, also has the potential to fight certain cancers and infectious diseases.

The trial will test MIS416, a naturally occurring agent derived from bacteria, in people with progressive multiple sclerosis (MS). The trial has begun recruiting patients and will be conducted at the Primorus Clinical Trials purpose-built unit in Christchurch.

Innate Therapeutics has sourced New Zealand and American funding for the trial. The Foundation for Research, Science and Technology (FRST) is investing NZ$600,000 through TechNZ, its business assistance programme. This is being matched with US$550,000 from the US not-for-profit, Fast Forward. Established by the United States National Multiple Sclerosis Society, Fast Forward is committed to providing support to accelerate the development of research discoveries into new or improved therapies for people with MS.

US and New Zealand MS specialists say MIS416 has the potential to change the landscape for people living with MS. It is understood to work by a combination of mechanisms involving down-regulation of chronic inflammation, reduction of autoimmune factors, and damaged tissue repair. There are currently no drugs specifically approved to treat the progressive forms of MS in New Zealand.

Innate Therapeutics’ CEO, Simon Wilkinson, said the company had chosen MS as its initial disease target because of very encouraging signs in a small number of patients who had early access (under the Medicines Act) to the drug on compassionate grounds and because of the funding from Fast Forward.

“We are delighted to gain the substantial funding invested by TechNZ and Fast Forward, which has allowed us to begin this important trial. The ongoing difficulty for small biotechs anywhere is funding and the mechanism that the US MS Society has established with Fast Forward encourages researchers and developers, such as ourselves, to come forward with candidates,” he said.

“However, as we have already found, the involvement with Fast Forward is more than about the dollars. We now have access to their networks and clinical expertise. MS is an exciting field to be in. For a therapeutic to be able to stop the progression of this debilitating condition is exciting. The wow factor would be seeing the partial reversal of symptoms.”

The Foundation for Research, Science and Technology’s General Manager Manufacturing and High Growth Firms, Richard Bentley, says the TechNZ investment was awarded with two key benefits in mind – for people living with MS and for New Zealand’s clinical trials sector.

“We think this investment has the potential to make a huge difference to developing a new therapy. Local clinical trial teams will also gain invaluable experience through working with international experts and other companies. This type of experience is hugely beneficial when it comes to building national capability. And the potential of economic gains to come with a successful trial, through licensing deals, is very exciting,” Mr Bentley said.

Fast Forward’s President Timothy Coetzee says: “The promise of current research like that undertaken by Innate Therapeutics to change the MS landscape is exciting and we are delighted to provide this support to speed the development of this new therapy that has the potential to help people living with MS”.

The Multiple Sclerosis Society of New Zealand’s National Director, Rosie Gallagher, says the society is extremely excited about the prospect of a new medication for those with progressive MS.

“There has been very little progress in terms of disease therapies for those with this type of MS and the fact that it is being developed by a Kiwi company and trialled within New Zealand is a great highlight for us. We offer our full support to this venture and hope for an outcome which will benefit those who are struggling with the effects of this devastating condition.”

Co-principal investigators for the Phase 2A trial are Primorus’ Medical Director and clinical trials specialist Dr Alison Luckey and Professor Tim Anderson. Professor Anderson is a consultant neurologist with the Canterbury District Health Board; Professor in the Department of Medicine, University of Otago, Christchurch; and Acting Director at the Van der Veer Institute for Parkinsons and Brain Research.

The initial stage of the trial aims to establish the recommended therapeutic dosage level of MIS416 administered weekly over a four week period in 12 to 18 patients. A dose confirmation stage will follow when 12-18 patients will be treated with the recommended dosage level weekly for a six month period.

With trials proceeding according to schedule, Innate Therapeutics estimates the drug could be on the market by 2016.

The company confirms it is also conducting preclinical studies using MIS416 in other applications, including oncology co-therapy and the treatment of infectious diseases.

About Innate Therapeutics

Innate Therapeutics Limited is a public unlisted biopharmaceutical company based in Auckland. The company is focussed on the development of a new generation of immune response modifiers for potential use in the treatment of MS and other autoimmune diseases, a range of infectious diseases, certain cancers, and as a novel cellular and humoral adjuvant. ENDS