ENGLEWOOD, Colo., Oct. 10, 2019 /PRNewswire/ -- Ampio
Pharmaceuticals, Inc. (NYSE American: AMPE) a development stage
biopharmaceutical company, executing a Special Protocol Assessment
(SPA) Phase III clinical trial titled "Evaluating the Efficacy and
Safety of AmpionTM to treat Adults with Pain Due to
Severe Osteoarthritis of the Knee," today announced 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:
Ampio's 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:
Ampio's CEO, Michael Macaluso,
acknowledged 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, we determined it would be prudent to build a compact (~3300
sq.ft.), highly efficient and cost-effective, GMP
manufacturing facility in our corporate headquarters. Importantly,
we 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, our
facility utilizes sterile, single-use processing disposables in an
automated, proprietary process that creates what we believe is a
market advantage with flexible pricing, strong operating margins
and the capacity to meet global demand. My confidence that our
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
(http://www.rmcpharma.com/) 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."
About Special Protocol Assessment (SPA)
A SPA
is a process in which sponsors may ask to meet with the FDA to
reach agreement on the design and size of certain clinical trials
to determine if they adequately address scientific and regulatory
requirements for a study that could support marketing approval. Our
SPA agreement for the above referenced study indicates concurrence
by the FDA with the adequacy and acceptability of specific critical
elements of overall protocol design for the study, which we intend
to support a future Biologic License Application (BLA).
About Osteoarthritis
Osteoarthritis (OA) is an
incurable and progressive disorder of the joints involving
degradation of the intra-articular cartilage, joint lining,
ligaments, and bone. Certain risk factors in conjunction with
natural wear and tear lead to the breakdown of cartilage. OA is
caused by inflammation of the soft tissue and bony structures of
the joint, which worsens over time and leads to progressive
thinning of articular cartilage. Other symptoms include narrowing
of the joint space, synovial membrane thickening, osteophyte
formation and increased density of subchondral bone.
About Ampio Pharmaceuticals
Ampio Pharmaceuticals,
Inc. is a development stage biopharmaceutical company primarily
focused on the development of Ampion, our product candidate, to
treat prevalent inflammatory conditions for which there are limited
treatment options. Ampio's lead drug, Ampion, is backed by an
extensive patent portfolio with intellectual property protection
extending through 2032 and may be eligible for 12-year FDA market
exclusivity if approved as a novel biologic under the biologics
price competition and innovation act (BPCIA).
Forward-Looking Statements
Ampio's statements in this
press release that are not historical fact, and that relate to
future plans or events, are forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
Forward-looking statements can be identified by the use of words
such as "believe," "expect," "plan," "anticipate," "would have" and
similar expressions. These forward-looking statements include
statements regarding Ampio's expectations with respect to Ampion™
and its classification, as well as those associated with pending
regulatory approvals and other FDA decisions, the Biological
License Application (BLA), the ability of Ampio to enter into
partnering arrangements, clinical trials and decisions and changes
in business conditions and similar events, all of which are
inherently subject to various risks and uncertainties. The risks
and uncertainties involved include those detailed from time to time
in Ampio's filings with the Securities and Exchange Commission,
including without limitation, under Ampio's Annual Report on Form
10-K and other documents filed with the Securities and Exchange
Commission. Ampio undertakes no obligation to revise or update
these forward-looking statements, whether as a result of new
information, future events or otherwise.
Company Contact
Dan
Stokely, CFO
Phone: (720) 437-6500
info@ampiopharma.com
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SOURCE Ampio Pharmaceuticals, Inc.