Antisense MS candidate well tolerated in monkeys

Antisense Therapeutics (ASX:ANP) has completed a toxicology study of multiple sclerosis drug candidate ATL1102 in monkeys, helping to pave the way for the first human trials since 2008.

ATL1102, an antisense oligonucleotide in-licensed from Isis Pharmaceuticals, was found to be well tolerated at both the 1.5 mg/kg and 3 mg/kg levels when delivered subcutaneously over a six-month dosing period.

After final analysis is conducted on the study results, Antisense plans to conduct discussions with regulatory agencies regarding a phase IIb trial of the drug candidate in MS patients.

The company expects to complete this review by June and conduct follow-up discussions with the US FDA at a pre-IND meeting in the third calendar quarter.

Antisense conducted a phase IIa human trial of ATL1102 which concluded in 2008. Results indicate that the drug is highly effective at reducing the number of lesions in MS patients.

But Antisense’s former partner for the drug, Teva Pharmaceuticals, decided to terminate its licence agreement in 2010 after conducting its own long-term toxicology study in monkeys. When announcing its decision, Teva took the view that the study should be repeated.

With this latest trial, Antisense has done so, and the positive results clear the path for the first long-term phase IIb trial in MS patients.

The company is also developing an inhaled form of ATL1102 as a potential asthma treatment and has also licensed two other antisense drug candidates from Isis. One is in preclinical development as a treatment for human growth hormone disorders and another is being evaluated as a cancer treatment.

Antisense Therapeutics (ASX:ANP) shares were trading 8.33% lower at $0.165 as of around 2 pm on Wednesday