Shares of Ampio Pharmaceuticals Inc. surged Tuesday after the Arapahoe County-based company said it is a step closer to bringing its knee osteoarthritis drug to market.
Ampio announced that it started a Phase 3 clinical study for Ampion, an injectable biologic drug developed to treat osteoarthritis-related knee pain and inflammation. The late-stage trial also received a “Special Protocol Assessment” from the U.S. Food and Drug Administration, indicating that the upcoming trial’s design and execution would be sufficient to support regulatory approval, Ampio officials said.
Ampio’s stock (NYSE MKT: AMPE) spiked more than 30 percent in morning trading, before closing up nearly 6 percent at $3.37.
If Ampion meets the FDA’s requirements, the drug could be classified as a novel biologic and receive 12 years of regulatory exclusivity.
“With positive results and an SPA, Ampion has a clearly defined path to market,” said Ampio CEO Michael Macaluso in a statement.
Ampio expects to have the results of the study — the company’s second Phase 3 trial — by the first quarter of 2016, said chief financial officer Gregory Gould.
Alicia Wallace: 303-954-1939, awallace@denverpost.com or @aliciawallace
