Ampio announced additional positive results from the SPRING study of Ampion for the treatment of osteoarthritis of the knee (OAK). Ampion, also known as aspartyl-alanyl diketopiperazine or DA-DKP, is an endogenous immunomodulatory molecule derived from the N-terminus of human serum albumin (HSA) that may have a significant role in the homeostasis of inflammation.
This 20-week extension of a multicenter, randomized, vehicle-controlled, double-blind study (NCT01839331) evaluated the safety and efficacy of a single intra-articular injection of Ampion treatment of inflammation-associated pain in symptomatic OA of the knee (OAK). Ninety seven patients who received a 4mL intra-articular injection of Ampion or vehicle control were followed for an additional 8 weeks beyond the initial 12-week endpoint of the SPRING study. Efficacy measures included changes from baseline in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) pain and function subscores. Patients were considered “responders” if they achieved ≥40% improvement in WOMAC pain and function.
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A summary of the results follows:
- In a subgroup of patients with moderate-to-severe OAK (Kellgren-Lawrence Grades 3–4; n=64), there were statistically significant improvements in WOMAC pain (mean change from baseline -0.99 vs. -0.65; P=0.005) and function scores (-0.85 vs. -0.58; P=0.04) over 20 weeks for patients who received Ampion compared with vehicle control, respectively.
- At 20 weeks, the percentage of patients in the moderate-to-severe subgroup who reported a reduction in pain was significantly higher for patients who received Ampion (50%) compared to those who received vehicle control (25%) (P=0.04).
- A single injection of Ampion was associated with sustained improvements in knee pain over 20 weeks (P=0.005).
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