US Patent allowance extends strong IP position
THE ROADHOUSE PHARMACY: Antisense Therapeutics (ASX: ANP) has been informed the US Patent Office has allowed US Patent 61/132973 entitled ‘Methods for treating multiple sclerosis (MS) using antisense oligonucleotides’.
Antisense said this covers the use of the ATL1102 compound to reduce brain lesions in relapsing-remitting multiple sclerosis (RRMS), and progressive forms of MS including secondary progressive MS (SPMS) and primary progressive MS (PPMS) and at the desired doses, until 23 June 2029, with potential for an extension of up to five years.
The company said the new US patent forms part of its portfolio of intellectual property protecting ATL1102 and its uses in MS and includes a granted United States patent US 8,415,314, Australian Patent 2009271678 and corresponding applications in Europe, Japan and Canada, covering the use of ATL1102 in the treatment of the most common form of the disease, RRMS.
This new US patent adds important commercial value to ATL1102 and further supports the company’s partnering plans with a recent publication showing that reduction in brain lesions with Tysabri® a monoclonal antibody drug to the VLA-4 receptor (same target as ATL1102), can benefit patients with progressive forms of MS.
There is only one approved compound in the US, Novantrone®, for use in secondary (chronic) progressive MS which can only be used for two to three years because of safety limitations.
The patent also claims all desired doses of ATL1102 for use in these treatments including those described in the pharmacometric modelling for dosing in the next clinical trial being a six month Phase IIb study.
The modelling recommended doses that on a cumulative basis are equivalent to those tested in the recent toxicology study.
The granting of the patent follows a previous announcement by Antisense in regards to major findings from an ATL1102 chronic monkey study and plans to meet with the FDA in Q3’2014 at a proposed pre-Investigational New Drug meeting regarding the study design for a Phase IIb MS trial.
The company said it expects these interactions with the FDA to run in parallel to those with potential pharmaceutical partners.
“We estimate that over $30 million has been spent on the development work undertaken to date by the company and its previous commercialisation partner in progressing ATL1102 in the MS indication towards moving the compound into a Phase IIb trial,” Antisense Therapeutics CEO and managing director Mark Diamond said in the company’s announcement to the Australian Securities Exchange.
“We are delighted that the recent findings from the toxicology study provide the opportunity for us to capitalise on this investment and this together with our US patents will underpin our partnering and commercialisation plans.”
Website: www.antisense.com.au