Centrexion Therapeutics: Positive Results for Knee OA Drug

All hail efforts to find non-opioid options for pain relief…Centrexion Therapeutics Corporation. is making headway in that department. The company has announced positive topline data from its Phase 2b randomized study of CNTX-4975 in patients with knee osteoarthritis (OA) pain.

According to the December 13, 2016 news release, “In the randomized, double-blind, placebo-controlled, multicenter TRIUMPH study, CNTX-4975, Centrexion’s proprietary lead pipeline candidate, met its primary endpoint of a reduction in pain with walking through 12 weeks with high statistical significance and demonstrated a duration of effect of at least 24 weeks after a single dose. At the 1.0 mg dose, two-thirds of patients achieved 50% or greater reduction in pain and nearly one-quarter of patients achieved a 90% or greater reduction in pain.”

Jeffrey B. Kindler, chief executive officer of Centrexion Therapeutics, stated, “With these positive data in hand, the recent Fast Track designation for CNTX-4975 in Morton’s neuroma, and our acquisition of three novel pain treatment programs earlier this year, we are advancing a robust and diverse pipeline of non-opioid, chronic pain therapies that have the potential to bridge the safety and efficacy gaps in current chronic pain management.”

Asked about the most exciting clinical aspect of this drug, Nathaniel Katz M.D., M.S., adjunct associate professor of anesthesia at Tufts University School of Medicine, told OTW, “There are millions of people who suffer from pain related to knee OA every day and they are primarily turning to knee replacements and opioids for relief. The overuse of opioids is a critical concern in our country, resulting in abuse, addiction and even death. The most exciting aspect of CNTX-4975 is that it is showing durable pain relief for OA patients and, as a non-opioid, does not have those risks of addiction or abuse. It is also expected to avoid the gastrointestinal and cardiovascular adverse effects that are associated with NSAIDs [non-steroidal anti-inflammatory drugs], the other leading treatment for osteoarthritis. We need new ways to treat the chronic pain issues we face in this country and the results of the TRIUMPH study indicate that CNTX-4975 warrants additional study to see if it can be a new treatment option.”

Jeffrey Kindler told OTW, “We will be meeting with the FDA to discuss our end-of-phase-two plan and then move to confirm these mid-stage study results in a larger, global Phase 3 study sometime next year. We also planned to present additional data from the Phase 2b trial at an upcoming medical meeting. Beyond CNTX-4975, we are advancing the three assets that we in-licensed from BI earlier this year. We plan to announce the initial of several Phase 1 trials in early 2017.”

“On a business development front, we are focused on building a company with a robust and diverse pipeline of non-opioid therapies that can transform how we treat chronic pain. For the long term growth of the company, we are keeping all options on the table at this time, but in particular we are considering a partner for the veterinary therapeutic.”

“As a company, we are moving with an increased sense of urgency because the need for new chronic pain therapies is so great. We know that people suffering from pain are waiting for non-addictive, safe, effective therapies.”