(AMPE - Get Report)
has touted the pain-relief efficacy of its osteoarthritis drug Ampion in three press releases since August but is so far refusing to provide clinical data sufficient to support its claims.
The Ampion data is missing from Ampio's "Spring" study, which compared two doses of Ampion to matching placebo in 329 patients with osteoarthritis of the knee. The knee of each patient in the study was injected once with either Ampion or saline. The study's primary endpoint was reduction in knee pain at 12 weeks compared to baseline.
Knee pain was assessed using the WOMAC A scale, which awards 0 points for no pain up to 4 points for extreme pain based on patient reporting.
Ampio needs two positive phase III studies in order to seek FDA approval of Ampion for osteoarthritis of the knee. The company is counting the "Spring" study as the first positive study. Ampio met with the FDA last month to discuss the "Spring" study results and requirements for a second phase III study of Ampion. The company hasn't commented publicly on the outcome of the FDA meeting but has previously guided to beginning the confirmatory Ampion study before the end of the year.
Investors who wish to evaluate Ampion's safety and efficacy are out of luck because Ampio had so far refused to disclose publicly relevant "Spring" study data, despite issuing three press releases touting positive results.
"As part of our market development plan for Ampion, we are planning to release all of the data, including important sub-population analyses and 20 week data in upcoming journals, medical conference presentations, and the public via press releases," said Ampio spokesman Rick Giles.
On Aug. 14, Ampio issued a press release announcing the
Ampion study achieved its primary endpoint
[reduction in knee pain] with "high statistical significance." Both the 4 ml and 10 ml doses of Ampion provided osteoarthritis patients with pain relief but there was no "significant difference" between the efficacy of the two Ampion doses, the company said.
Here are the Ampion results Ampio chose to include in its announcement:
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.