Ampio modifies Ampion IND to include dose escalation run-in study Ampio Pharmaceuticals announced that it's Phase III clinical study of Ampion for the treatment for osteoarthritis of the knee will include a dose-escalation run-in study as recommended by the FDA. Dr. Vaughan Clift, Ampio's Chief Regulatory Officer, noted "The company has modified the original study design to accommodate the FDA recommendations and submitted this upgraded IND study protocol for clearance to begin treating patients. A Clinical Research Organization has been engaged and multiple clinical sites have been selected that are ready to enroll patients in the study. The dose ranging run-in study will commence shortly and will include 320 patients in total comparing 4 ml to 10 ml injection using the WOMAC pain scale."
Ampio says Optina benefit not significant vs. placebo, Bloomberg reports Vaughan Lennox Clift, Chief Regulatory Affairs Officer of Ampio, told Bloomberg in a phone interview that Optina's benefit is not significant versus the placebo. Optina helped a group improve from baseline, Bloomberg adds. Clift also said the FDA may allow narrow sales with a post-market study.