Ampio Pharmaceuticals announced an update to the Phase 3 multicenter, double-blind STEP study of Ampion for osteoarthritis (OA) of the knee.
The STEP study enrolled 538 patients, 269 patients received Ampion and 269 patients received saline vehicle control. The primary efficacy endpoint was reduction in pain, as measured by the WOMAC A pain subscore. Review of the data from the STEP study confirmed that 382 (72%) patients received study medication that had fallen below the product specification temperature range. The average length of exposure below this temperature range was 16.1 hours (max 36.3 hours).
Although the majority of patients received study drug that had fallen below recommended temperature ranges, efficacy was demonstrated in patients with the most severe form of osteoarthritis (Kellgren-Lawrence grade IV, KL IV) for which the only current alternative therapy is knee joint replacement:
- The treatment effect differed based on the temperature excursion from the recommended range (interaction P<0.001). Patients receiving study drug with temperature excursions had varying treatment effects depending on the lowest temperature that was reached during transport of the study drug.
- There was a significant interaction observed between OA severity, as measured by Kellgren-Lawrence grade, and treatment effect (interaction P<0.001).
- Over one-third of patients enrolled were Kellgren-Lawrence grade IV (n=185).
- The change in WOMAC A Pain from baseline to week 20 for all 185 KL IV patients, inclusive of temperature excursions, was trending towards significantly greater reductions in pain following treatment with Ampion (-0.86), than that of saline vehicle control (0.66), P=0.08.
- In KL IV patients with temperature excursions (134 patients), significantly greater reductions in pain were reported following treatment with Ampion (-0.85) compared to saline (-0.58), P=0.04. Likewise, there was a significantly greater improvement in function following treatment with Ampion (-0.87) compared to saline (-0.59), P=0.03.
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