Phase 2 of new painkiller for OA patients.
The trial will have a two-stage adaptive design.
The initial stage is an open-label trial to detect the optimal dose range for the efficacy profile.
Subjects enrolled in this stage of the trial will be given one subcutaneous dose of OLP-1002 ranging between 1mcg and 80mcg.
The placebo-controlled, double-blind second stage of the trial will analyze two doses of the painkiller chosen as per the data from the first stage.
In October last year, the South Korea-based biotech firm obtained approval from the Australian regulatory authority for the trial.
OliPass Corporation CEO Dr Shin Chung said: “OLP-1002 is an SCN9A antisense peptide nucleic acid (PNA) and selectively inhibits the expression of Nav1.7 sodium channel, and therefore expected to replicate much of the phenotype of people with SCN9A channelopathy.
“Early readouts from the ongoing Phase IIa trial are consistent with our expectations for OLP-1002 as a selective inhibitor of the Nav1.7 sodium channel.
“Even though the early readouts may look very promising, the therapeutic profile of OLP-1002 has yet to be validated by a placebo-controlled evaluation in a larger number of patients.”
OliPass focuses on developing Ribonucleic acid (RNA) treatments leveraging Olipass Peptide Nucleic Acid (OPNA), its oligonucleotide platform.
OPNA was obtained by making chemical alterations to PNA to boost cell permeability, as well as RNA affinity.
It is claimed to attach to target pre-mRNA, elicits exon skipping and results in mRNA splice variant for treatment intervention.
As against various other kinds of RNA treatments, OPNA does not need formulation support for in vivo therapeutic activity.