Centrexion completes enrolment in Phase III CNTX-4975 trial

7th December 2018 (Last Updated December 7th, 2018 00:00)

Centrexion Therapeutics has completed patient enrolment ahead of schedule in the Phase III VICTORY-1 trial assessing the safety and efficacy of CNTX-4975 for the treatment of individuals with moderate-to-severe knee osteoarthritis (OA) pain.

Centrexion Therapeutics has completed patient enrolment ahead of schedule in the Phase III VICTORY-1 trial assessing the safety and efficacy of CNTX-4975 for the treatment of individuals with moderate-to-severe knee osteoarthritis (OA) pain.

The randomised, double-blind, placebo-controlled trial will be conducted over a 52 week period and has enrolled a total of 325 patients.

It aims to examine the effects of a single intra-articular injection of CNTX-4975.

The trial's primary objective is the change in pain with walking at week 12, as measured by Numeric Pain Rating Scale (NPRS).

Its secondary objectives comprise improvement in the average knee stiffness and function measured at week 12.

Additional secondary objectives include change in knee pain, knee stiffness and function, and patient global impression of change (PGIC).

"We have designed the OA-303 study to provide additional information beyond just fulfilling the required safety database."

Topline results from the trial are scheduled to be available in the first quarter of 2020.

Centrexion Therapeutics CEO Jeffrey Kindler said: “VICTORY-2, the second pivotal trial which includes repeat dosing, is also underway, with site initiation and enrolment progressing as anticipated.

“The OA-303 open label, eight-week study in 850 subjects is enrolling on schedule and we expect to have topline results reported in 2019.”

CNTX-4975 is an investigational synthetic, ultra-pure intra-articular injection of trans-capsaicin.

It can be administered directly into the joint where the pain stimulus generates.

Centrexion chief medical officer Randall Stevens said: “We have designed the OA-303 study to provide additional information beyond just fulfilling the required safety database.

“The study design includes efficacy readouts in additional patient populations such as injection of CNTX-4975 in both knees in patients with bilateral knee OA pain and patients with prior knee joint replacement in the non-index knee.

“It will also evaluate variations of the CNTX-4975 administration procedure designed to enable physicians to select options that best fit their practice dynamics and patient needs.”