Patients receiving Ampion achieved a significantly greater reduction in pain (WOMAC A) from baseline to 12 weeks compared to saline vehicle control (p=0.0038). Patients receiving Ampion experienced, on average, a greater than 40% reduction in pain from baseline.Ampio failed to disclose any numerical data on pain reduction for patients treated with Ampion. Claiming Ampion patients experienced a 40% reduction in knee pain means little if the company doesn't tell us how much pain they were experiencing at the start of the trial. Think of it this way: If I offered you 40% of the contents of a sealed safe deposit box in exchange for $100, you'd want to know if the box contained $1 or $1 million before accepting the offer.
This study demonstrated that a single intra-articular (IA) injection of Ampion resulted in a clinically and statistically significant reduction in pain, with an estimated difference from control at the study endpoint of -0.25 on the WOMAC A scale (95% CI: -0.41 to -0.08, p=0.004), corresponding to a 42.3% improvement in pain at 12 weeks in patients treated with Ampion. Note: In contrast, despite recommendations against their use, Hylan G-F 20 is the current treatment of choice in patients who cannot be managed with analgesics. In the pivotal trial of a single IA injection of 6 ml Hylan G-F 20, a borderline statistically significant reduction in pain was demonstrated, with an estimated difference from control of -0.15 (95% CI: -0.30 to -0.002, p=0.047), corresponding to a 31.3% improvement in pain over 26 weeks in patients treated with Hylan G-F 20.Here, Ampio is looking across two different clinical trials to claim Ampion is superior to Hylan G-F 20, an approved osteoarthritis injection sold by the Genzyme unit of Sanofi ( SNY) under the brand name Synvisc. But again, Ampio doesn't provide the data from its own study to back up the superiority claim. The 0.25 difference on the WOMAC A scale favoring Ampion over placebo is an incremental nugget of data, but Ampio doesn't disclose baseline or post-treatment changes in pain scores for Ampion and placebo patients, respectively. The company clearly has these data, so why not disclose? This is what the WOMAC A pain score data look like from the Snyvisc label approved by the FDA. These data come from the pivotal phase III study conducted by Genzyme:
In the 329-patient Spring study, both the efficacy and safety of the 4 ml and 10 ml doses were equivalent. Both doses were independently statistically significant, therefore Ampio selected 4 ml as the optimal dose for the extended study and followed the 97 patients who were administered either 4 ml Ampion or saline vehicle control for an additional 8 weeks.Why is patient participation in the 8-week extension study so low? Let's do some math: The "Spring" study enrolled 329 patients, equally randomized to four arms -- 4 ml Ampion and a matching placebo or 10 ml Ampion and a matching placebo. That means each arm had 82 patients, or 164 patients in the 4 ml Ampion/matching placebo arms. By Ampio's own admission, only 97 patients, or 59%, treated with either 4 ml of Ampion or matching placebo chose to enter the extension study. That's a relatively small percentage of patients choosing to move forward into the extension study, which could have (should have) been closer to 80-90% based on the purported efficacy of Ampion.