ENGLEWOOD, Colo., March 6, 2019 /PRNewswire/ -- Ampio
Pharmaceuticals, Inc. (NYSE MKT: AMPE) today updates the regulatory
status of Ampion™.
Food and Drug Administration (FDA) provided guidance that Ampio
should complete an additional trial of Kellgren Lawrence Grade 4
(KL 4) osteoarthritis of the knee (OAK) patients with concurrent
controls that would be carried out under a Special Protocol
Assessment (SPA). Ampio presented the FDA with two different forms
of concurrent controls the company was considering in trial design:
a saline injection or a sham injection, both previously identified
by the FDA as possible controls. FDA correspondence, received on
March 5, 2019, allows the Company to
use either sham or saline intra-articular injection as a concurrent
control in a confirmatory clinical study design.
Michael Macaluso, Ampio's CEO
noted that, "Taken as a group, the total KL 4 patient population
receiving Ampion within our single injection clinical trials
provided statistically significant superior results compared to
those patients receiving the saline injection control. Therefore,
we feel confident with the choice of either control option. The
company will quickly determine which control to include in our
trial design and then update and resubmit our SPA. We will be ready
to begin the confirmatory clinical trial as soon as the SPA is
awarded."
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 a
therapy to treat a prevalent inflammatory condition for which there
are limited treatment options. We are developing a compound that
decreases inflammation by inhibiting specific pro-inflammatory
compounds.
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
Phone: (720) 437-6500
aramirez@ampiopharma.com
Ampio Pharmaceuticals, Inc.
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SOURCE Ampio Pharmaceuticals, Inc.