OliPass Corporation announced to move forward to the second stage of the Phase 2a trial in Australia in osteoarthritis (OA) patients for pain killer OLP-1002, an SCN9A antisense PNA selectively inhibiting the expression of Nav1.7 sodium ion channel. The Phase 2a study consists of two stages. The first stage is an open label study to identify an optimum dose range meeting the target efficacy and therapeutic duration, in which patients receive a single subcutaneous injection of 1, 3, 10, 25, 50 or 80 mcg (microgram) OLP-1002.

Low doses and high doses have been simulated to inhibit Nav1.7 expression mostly in peripheral nerves and the spinal cord, respectively. The second stage shall be a placebo-controlled double blind study to evaluate two doses of OLP-1002 selected based on the efficacy findings from the first stage. The company briefed on the clinical readouts from the ongoing open label study as follows: Pain reductions on a daily basis were marked and persisted at least a month in all the 5 patients received 1 mcg OLP-1002.

The average daily pain reductions by VAS were robust and ranged from 60% to 85% over the period of 30 days post dose. The maximum was observed around a week post dose. Interestingly the onset time was shorter than several hours.

Pain reductions by WOMAC were comparable to those by VAS. Although the dosing and pharmacodynamic evaluation of 80 mcg OLP-1002 have yet to be completed, 50 mcg OLP-1002 appears to be the dose picking up pain reduction by CNS target engagement.