Ampio pharmaceuticals, inc. updates on the ap-013 phase iii clinical trial; provides progress update of ampion manufacturing facility

Ampio pharmaceuticals, inc. updates of the continued progress with their phase iii ap-013 clinical trial and their state-of-the-art manufacturing facility. progress update on ap-013 clinical trial: ampios coo, holli cherevka, noted that ampio is now enrolling patients at 23 of the 25 clinical sites authorized by the fda and, as of october 8th, of the 1,034 patients to be enrolled in ap-013, 510 have been injected and an additional 63 are currently in the screening. it is important to note, ms. cherevka continued, in the three randomized single-injection studies previously run by the company, both reduction in pain and improvement in function were significantly greater for kl 4 patients treated with ampion vs saline. these results imply that had there been increased patient enrollment, the p-values in each case would have demonstrated a statistically significant clinical benefit with the treatment utilizing ampion compared to saline. the company believes the fda approved spa trial design supporting the current ap-013 study addresses this issue by allowing > 1,000 kl 4 patients to be dosed. in fact, the combined results of the prior single injection trials showed twice the necessary efficacy for both pain and function to be statistically significant in ap-013 (p-value < 0.05). progress update of ampion manufacturing facility: the company announced that it was unusual for a development stage biopharmaceutical company the size of ampio to have constructed a gmp turnkey manufacturing facility capable of supplying global demand for its lead product, and further explained the rationale: since dr. david bar-or was able to develop a process by which ampion is extracted through utilization of a proprietary filtration process of the fda licensed blood product, human serum albumin (hsa), and the company was confident of the efficacy of the drug, they determined it would be prudent to build a compact (~3300 sq.ft.), highly efficient and cost-effective, gmp manufacturing facility in its corporate headquarters. importantly, they believe this will enable the company to have direct oversite and control over the ongoing manufacturing and commercial launch of ampion shortly after fda approval of ampion. furthermore, their facility utilizes sterile, single-use processing disposables in an automated, proprietary process that creates what they believe is a market advantage with flexible pricing, strong operating margins and the capacity to meet global demand. my confidence that its manufacturing facility will meet both short and long term demand, should ampion receive fda approval, is supported by the following: all the required fda cmc manufacturing pilot lots have been completed and documented. approximately 200,000 ampion vials have been filled without contamination. the “ball room” platform technology used in the facility is flexible and supports possible expansion of indications by providing filling of iv bags and syringes as well as vials. based on observed production rates, the three-shift annual capacity of this facility would be ~ 8,000,000 vials at very low direct product cost and strong operating margins. the company engaged rmc pharma an independent third-party regulatory consulting firm to conduct a comprehensive audit over multiple days while the company was conducting cmc manufacturing runs. the audit results reflected no serious negative findings and rmc concluded in their opinion the facility is ready for fda audit. the company has secured long term hsa supply agreements.
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