Sorrento Therapeutics has treated the first patient enrolled in the PTVA-OA-001 trial and is set to continue the study after the data monitoring committee (DMC) found no safety concerns associated with the drug in a scheduled safety assessment.
The PTVA-OA-001 trial is a Phase lb study to investigate the safety and define the maximally tolerated dose of resiniferatoxin (RTX) administered in the knee joint for the reduction of moderate-to-severe pain signal intensity associated with osteoarthritis.
The multicentre, placebo-controlled trial is expected to enrol 40 patients in up to five dose level cohorts.
PTVA-OA-001 features a dose-escalation design, where cohorts of patients will receive increasing doses of resiniferatoxin until the maximum tolerated dose (MTD) is achieved.
The trial’s primary endpoint is to analyse the safety of resiniferatoxin and identify the recommended Phase ll dose.
The secondary endpoint of the trial is to evaluate the preliminary efficacy of resiniferatoxin measured by assessing changes in the intensity of pain using the WOMAC Index.
Sorrento expects to stop the study once a clearly effective dose or a maximum tolerated dose is reached prior to the highest dose scheduled to be received.
The trial is scheduled to be completed within the first half of next year.
Sorrento Therapeutics chief medical officer Dr Jerome Zeldis said: “Joint pain affects over 30 million patients in major markets, half of which suffer from knee osteoarthritis pain.
“A clear unmet need for a single-administration, long-lasting, non-opioid and non-steroidal pain control solution exists for this degenerative joint disease.
“We believe resiniferatoxin has the potential to adequately address this need and may help limit chronic use of other pain medications, including opioids.”
Resiniferatoxin is a non-opioid, afferent nerve ablating drug candidate currently under development by Sorrento.