ENGLEWOOD, Colo., Dec. 4, 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
Ampion™ to treat Adults with Pain Due to Severe Osteoarthritis of
the Knee", today announced updates regarding the
continued progress of its Phase III AP-013 clinical trial and its
manufacturing facility.
Clinical Trial Update:
Ampio's COO, Holli Cherevka,
summarized:
- "As of December 3,
2019, of the 1,034 patients to be enrolled in AP-013, more
than 700 have been injected and an additional 50 patients have been
approved for injection in the near term. As more than 350 patients
have now reached the study's 12-week primary endpoint, the clinical
trial is more than 33% complete. Exclusions from the more than
1,050 consented patients continues to average 29% in order to
ensure enrollment of only patients with severe
osteoarthritis of the knee who do not have other pain or medical
conditions that could interfere with their assessment
of the pain and function in the injected knee."
- "On October 22, 2019, the
independent Safety Monitoring Committee completed a confidential
review of the results from the first 300 randomized subjects.
As a result of the review, the current safety profiles of Ampion
and the placebo injections are similar, and to date, study
investigators have identified no remarkable safety findings. These
results are consistent with the safety profile observed in over
2,000 patients in the Ampion clinical development."
Manufacturing Facility Update:
- Ampio has built a compact, highly efficient and cost-effective,
GMP manufacturing facility at our corporate headquarters to enable
the Company to have direct oversite and control over the ongoing
manufacturing and commercial launch of Ampion shortly after FDA
approval of Ampion. This facility utilizes sterile, single-use
processing disposables in an automated, proprietary process that
creates a market advantage with flexible pricing, strong operating
margins and capacity to meet global demand.
- All CMC validation lots for BLA submission 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 the possible expansion of indications by
providing filling of IV bags and syringes as well as vials.
- Based on observed production rates, the Company believes that
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 the facility is ready
for FDA audit.
Ampio Annual Meeting & Broadcast:
On
Saturday, December 14, 2019 at
9:00 AM MT, Ampio will be holding
their annual meeting, which will be accessible to all investors
calling in at:
U.S./Canada toll-free number:
877-901-1999
U.S. Local number: +1 267-930-4000
Participant Passcode: 853-458-357
Additional updates, if any, regarding the AP-013 Phase III
Clinical trial may be discussed at this meeting
An audio replay of this Annual Meeting will be posted on Ampio's
website within 24 hours. Link at
https://ampiopharma.com/investors/presentations-media/
About Special Protocol Assessment (SPA)
A SPA is a
process in which sponsors may ask to meet with the FDA to reach an
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 will be eligible for 12-year
FDA market exclusivity upon approval 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," 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 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
Daniel G. Stokely, CFO
Phone: (720) 437-6500
info@ampiopharma.com
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SOURCE Ampio Pharmaceuticals, Inc.