Study of Ampion (aspartyl-alanyl diketopiperazine) for pain in knee osteoarthritis to be published in Orthopedics.- Ampio Pharma.

Ampio Pharmaceuticals announced that a manuscript on the use of Ampion (aspartyl-alanyl diketopiperazine) titled: "LMWF-5A For The Treatment Of Severe Osteoarthritis Of The Knee: Integrated Analysis Of Safety And Efficacy" was accepted for publication in Orthopedics, an international peer-reviewed journal in the field of Orthopedics.

This pooled analysis demonstrated that a single-injection of Ampion was safe and well tolerated across all trials. Patients treated with Ampion were also significantly more likely to respond to treatment and with a longer duration of response as compared to saline. These results are clinically important and provide support for Ampion� for the indication of pain due to severe osteoarthritis of the knee (OAK).

Comment: Ampion is in late-stage development to treat the signs and symptoms of severe OAK. Based on FDA guidance, Ampio recently completed enrollment in the 12-week pivotal trial of Ampion, which enrolled patients with severe OAK (KL grade 4) to evaluate the efficacy of Ampion for the treatment of pain, function, and Patient Global Assessment (PGA). The primary study endpoint is the OMERACT-OARSI responder criteria.