ENGLEWOOD, Colo., Feb. 6, 2019 /PRNewswire/ -- Ampio
Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced it had
received an initial response from the U.S. Food and Drug
Administration (FDA), Office of Tissue and Advanced Therapies
division regarding the Company's submission of a proposed trial
design for the treatment of KL4 Osteoarthritis patients with
Ampion™. The trial design includes concurrent controls and would be
carried out under a Special Protocol Assessment (SPA).
![Ampio Pharmaceuticals Logo. (PRNewsFoto/Ampio Pharmaceuticals, Inc.) (PRNewsfoto/Ampio Pharmaceuticals, Inc.) Ampio Pharmaceuticals Logo. (PRNewsFoto/Ampio Pharmaceuticals, Inc.) (PRNewsfoto/Ampio Pharmaceuticals, Inc.)](https://mma.prnewswire.com/media/479965/Ampio_Pharmaceuticals_Logo.jpg)
Michael Macaluso, Ampio's CEO,
explained: "A SPA is an agreement between the sponsor and FDA that
the trial design, clinical endpoints, and statistical
analyses could support marketing approval. The recently
received FDA correspondence included guidance and questions that
require a response from Ampio, which is routine under these
circumstances. We are preparing our response to their comments that
will include additional questions to allow maximum clarity. We will
provide an update as soon as this process is completed."
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. The incidence of developing
osteoarthritis of the knee over a lifetime is approximately 45%. As
this disease is associated with age, obesity, and diabetes, this
number will continue to grow. Certain risk factors in conjunction
with natural wear and tear lead to the breakdown of cartilage.
Osteoarthritis 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
therapies to treat prevalent inflammatory conditions for which
there are limited treatment options. We are developing compounds
that decrease inflammation by (i) inhibiting specific
pro-inflammatory compounds by affecting specific pathways at the
protein expression and at the transcription level; (ii) activating
specific phosphatase or depletion of the available phosphate needed
for the inflammation process; and (iii) decreasing vascular
permeability.
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 including the timing thereof, 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
April Ramirez
Operations Manager
Phone: (720) 437-6500
aramirez@ampiopharma.com
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SOURCE Ampio Pharmaceuticals, Inc.