Drug Development

Learning from past mistakes, Centrexion clears a big PhIIb hurdle for its pain drug

Jeffrey Kindler, Centrexion

Jeffrey Kindler, Centrexion

Jeffrey Kindler’s biotech startup Centrexion is boasting about its lead drug’s success in a Phase IIb pain study for knee osteoarthritis.

The ex-Pfizer CEO’s Boston-based biotech says that CNTX-4975, injected directly into the joint, delivered pain relief to a fairly large group of patients who had failed on first-line pain drugs, setting them up to go into a late-stage pivotal program next year.

Centrexion’s Randall Stevens, the chief medical officer, says that two third of the patients taking the drug in the 175-patient study achieved a 50% or greater reduction in pain. And close to one in four experienced a 90% or greater reduction in pain.

A single injection got a fast onset of response, Stevens tells me. And with a short half life, he says, they can limit any adverse events as the body clears the drug within 24 hours.

“We start seeing a statistical separation at 1 week and throughout 12 weeks of the endpoints,” he says. “When you look at 24 weeks, we still see a statistical separation at 24 weeks.”

Randall Stevens, Centrexion

Randall Stevens, Centrexion

The drug they’re working on is an injectable trans-capsaicin that works by targeting the TRPV1 receptor, designed to inactivate the local pain fibers that transmit signals to the brain. Over the years, there have been a number of pain drugs that have faltered in the clinic due to high placebo responses. But the company has learned from those past mistakes, he adds, including some new measures to help blunt any possible placebo responses.

As an example, he said that the research staff at sites are trained to handle all patients in a cool and professional manner, as pampering or “coddling” can prompt positive responses.

The development strategy at Centrexion, which has been building its pipeline, is centered on finding non-opioid therapies that can offer a nonaddictive approach to pain control. And the company believes it’s on the right track, to date.

The plan now is to meet with the FDA in the first half and then launch the Phase III study in the second half. Items like the number of patients needed to recruit and the length of the study all have to be worked out.


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RAPS Regulatory Convergence 2017