Innates chief executive Simon Wilkinson says the US patent is a significant milestone as the US market represents around 70% of the worldwide MS market by revenue. He says currently there are no drugs approved to effectively treat SPMS.
The granting of the patent comes ahead of the worlds largest annual gathering of the healthcare/pharmaceutical investment sector in early January. The JP Morgan conference in San Francisco attracts major investors and pharmaceutical companies. While big listed companies take centre stage with their plans for the coming 12 months at the conference, Mr Wilkinson says companies like Innate will also be there talking with potential investors.
Following the success of our Phase 2A trials, where the data showed 80% of the patients had at least a 30% (or greater) improvement in at least one measure of MS related clinical status, we have attracted interest from both pharmas and investors, he says.
Innate is now looking to convert this interest into funding for a larger randomized Phase 2B clinical trial. Meanwhile patent applications for MIS416 have been filed in other major markets including Europe, United Kingdom and Australia.
In parallel with the planning for the 2B study, Innate has expanded its NZ 'compassionate use' access programme to allow 12 patients from the completed 2A trial to stay on treatment at the patients request. This brings the total number of patients with progressive MS who have received MIS416 on compassionate grounds to 21.
In 15 patients with SPMS who have received six or more doses, 13 (87%) have reported modest to significant improvement in their health-related quality of life.
Of the seven patients who have been on treatment for 20 weeks or more, six (86%) report sustained improvements. MS related quality of life improvements are measured using the internationally accepted "MS Quality of Life Inventory" (MSQLI) assessment tool.