Antisense Therapeutics Limited (“ANP” or the “Company”) is pleased to advise that results from a chronic toxicity study in monkeys indicate that ATL1102, an antisense oligonucleotide currently under development for the treatment of multiple sclerosis (MS), was well-tolerated when given subcutaneously for a 6-month dosing period at the 2 dose levels tested (1.5 and 3mg/kg/dose). The Company believes that the preclinical and clinical experience to date with ATL1102 should allow dosing in future trials at or above the 1.5 mg/kg/dose level.
Based on histologic findings in common with a previous monkey study at doses exceeding 1.5mg/kg/dose, the Company continues to evaluate the chronic monkey data with regard to potential human relevance, and safety biomarkers that may be useful in future clinical studies. Exposures achieved in this study are regarded as potentially clinically relevant based on the efficacy outcomes from the previously conducted Phase IIa trial of ATL1102 in MS patients.
Pending receipt and final data evaluation from the current study, as well as review of all the preclinical and clinical data obtained, ANP is planning future regulatory agency discussions regarding further development of ATL1102 and the dosing regimen for a future Phase IIb trial in MS patients. The Company anticipates final review of the data by June this-year and follow-up discussions with the US Food and Drug Administration (FDA) at a pre-IND meeting during the 3rd quarter 2014.
Antisense Therapeutics CEO and Managing Director Mark Diamond said “The results of this most recent toxicology study and the human data to date are encouraging and re-ignite our hopes for this project. We are continuing to generate new data on ATL1102 which we believe will support positive interactions with the FDA in relation to our plans for a future Phase IIb trial in MS patients. We look forward to confirming our plans for the further clinical development of ATL1102 with the FDA in the coming months.”