Déjà vu at Ampio Pharmaceuticals ($AMPE) as its shares tumbled by 61% yesterday after it posted new data showing its osteoarthritis of the knee drug once again failed to hit its primary endpoint.
The candidate, Ampion (aspartyl-alanyl diketopiperazine), failed to improve pain in 480 patients with osteoarthrosis (OA) of the knee after 3 months compared to saline in the late-stage, PIVOT trial.
And it’s second time unlucky for the drug as last April it also failed in a Phase III test.
The Englewood, CO-based Ampio biotech said last year that its lead candidate was undone by an “unexpected placebo response.” The market wasn’t convinced however and its shares tanked by 60%. Placebo response was not blamed for this second late-stage disappointment.
The non-steroidal biologic is believed to have an anti-inflammatory effect by suppressing pro-inflammatory cytokine production in T-cells.
But despite these setbacks--and following a defiant pattern among other biotechs in recent months--the company says it will still seek talks with the FDA about submitting its drug for approval.
Michael Macaluso, Ampio's CEO explained: “Even though we did not meet the primary endpoint in the PIVOT study, we are pleased with the consistent effect Ampion demonstrated in all of our clinical trials. Ampio is requesting a meeting with the FDA to present our data in support of Ampion.”
It’s not the only biotech to have trouble with OA of the knee trials, as in 2014 Flexion Therapeutics ($FLXN) saw the FDA place a clinical hold on enrollment and dosing in a Phase IIb study on its candidate Zilretta (FX006) over safety concerns.
The drug, a sustained-release steroid treatment, had a better show in February this year however when Zilretta hit its primary endpoint of lessening pain in a new Phase III trial.
- check out the release