Anika Therapeutics, Inc. (NASDAQ: ANIK), a global joint
preservation company focused on early intervention orthopedics,
today announced that Cingal® met its primary endpoint in a Phase
III Study (Cingal 19-01), demonstrating superiority over
triamcinolone hexacetonide (TH) steroid alone at 26 weeks
post-treatment. The Cingal 19-01 Phase III study is the third
completed Phase III study of Cingal and, together with previous
studies, has now demonstrated superiority over each of its active
ingredients and placebo. Across the three completed Phase III
studies, Cingal demonstrated a mean 71% pain improvement from
baseline and a mean 91% of Cingal subjects were deemed to be
Responders.
Cingal is a combination product of cross-linked
hyaluronic acid (HA) proven to provide long lasting pain relief
through 6 months plus TH steroid to provide fast, short-term pain
relief, both of which has been approved for sale in the United
States, to treat the pain of knee osteoarthritis (OA). Cingal is
currently sold in more than 35 countries outside the United
States.
Anika will engage with the U.S. Food and Drug
Administration (FDA) in the coming months on next steps for U.S.
regulatory approval. In parallel, Anika is exploring the potential
to advance Cingal through commercial partnerships in the U.S. and
select Asian markets. These efforts will inform next steps,
including if and how to proceed with another clinical trial in the
United States.
“We are excited that Cingal successfully met the
primary endpoint of this third Phase III study, and again confirmed
the strong and durable pain relief observed in previous studies,”
said Anika’s President and CEO, Cheryl R. Blanchard, Ph.D.
“The successful results of this study represent a significant
clinical milestone for Anika, and we look forward to meeting with
the FDA to discuss next steps for U.S. regulatory approval. We
believe that Cingal offers compelling clinical benefits to patients
in terms of pain relief, durability of pain relief, responder rates
and safety profile based on our established, real-world success
with Cingal in over 35 countries outside the United States, as well
as the totality of the data observed in our three completed Phase
III studies. Cingal is a game-changing, next generation product for
patients suffering from osteoarthritis, and we believe these
clinical data position us well to further advance Cingal.”
Significant Market Opportunity Underscored
by Successful Commercialization of Cingal in Over 35 Countries
Outside the United States
Since 2016, Anika has successfully commercialized
Cingal in over 35 countries outside the United States and controls
full global rights. Anika is focused on further unlocking the
clinical and commercial potential of Cingal in the United States
and select Asian markets. A United States approval of Cingal by the
FDA would significantly bolster Anika’s knee OA pain management
portfolio with a market expanding, next generation OA product.
Cingal has the potential to address a true unmet medical need for
the more than 32 million patients in the United States suffering
from osteoarthritis, with an estimated next generation OA U.S.
market opportunity of at least $1 billion with additional expansion
opportunities internationally.
Summary of the Cingal 19-01 Phase III Study
Results
The Cingal 19-01 Phase III study was a multicenter,
randomized, double-blind, parallel group, placebo-controlled,
active comparator study that evaluated OA subjects at 26 sites in
the United States. In total, 231 subjects were randomized into
three treatment arms (Cingal (99 subjects), TH steroid alone (99
subjects) and placebo (saline) (33 subjects)). Anika conducted the
Cingal 19-01 Phase III study with the aim of de-risking the Cingal
clinical development program by demonstrating that a study that was
placebo-controlled and enrolled patients with a higher pain score
at baseline would show superiority of Cingal over TH steroid at 26
weeks.
The pre-specified primary analysis of the primary
endpoint of the study was to evaluate change from baseline in knee
pain as measured by the Western Ontario and McMaster Universities
Osteoarthritis (WOMAC) Pain Index at 26 weeks post-treatment,
comparing the Cingal arm to the TH steroid arm. WOMAC Pain Index is
a widely used set of standardized questionnaires for health
professionals to evaluate the condition of patients with
osteoarthritis of the knee.
The 19-01 study met its primary endpoint and
demonstrated superiority of Cingal over TH steroid at 26 weeks
post-treatment based on change in WOMAC Pain Index from baseline
(p=0.0406). The figure below shows the change in WOMAC Pain Index
from baseline across all measured timepoints.
In addition, Cingal demonstrated strong performance
for pain reduction with 66% improvement in WOMAC Pain Index
(-44.3mm from baseline) and 90% of subjects were deemed to be
OMERACT-OARSI Responders at 26 weeks post-treatment. OMERACT-OARSI
is a recognized method of evaluating responder rates based on
improvement in pain and function.
Cingal was well-tolerated in the study, with only
transient and non-serious adverse events (e.g., arthralgia,
injection site pain, swelling, stiffness) related to the study
injections.
Summary of the Cingal Phase III Clinical
Program
The Cingal 19-01 Phase III study is the third
completed Phase III study of Cingal in OA patients. A total of 741
patients have been treated with Cingal in this clinical program
yielding consistent and significant pain reduction for six months
in this difficult to treat patient population.
In combination, Anika’s Phase III program has now
demonstrated superiority of Cingal over each of its active
ingredients and placebo. Cingal demonstrated superiority over the
HA component (Monovisc®) at 1 week and 3 weeks post-treatment in
the 13-01 study (p=0.0367 and p=0.0289), superiority over the TH
steroid component at 26 weeks post-treatment in the 19-01 study
(p=0.0406), and superiority over placebo at 12 weeks and 26 weeks
post-treatment in the 13-01 study (p=0.0013 and p=0.0027).
Percent improvement for Cingal in change of WOMAC
Pain Index from baseline at 26 weeks post-treatment was 72% for the
13-01 study, 73% for the 16-02 study, and 66% for the 19-01 study
in a more difficult patient population (mean 71% improvement across
all three studies). In addition, the percent of Cingal subjects who
met criteria for the OMERACT-OARSI Responder Index at 26 weeks was
92% in the 13-01 study, 91% in the 16-02 study, and 90% in the
19-01 study (mean 91% Responders across all three studies). Cingal
was well-tolerated with a consistent safety profile across all
three studies, with no serious adverse events (SAEs) related to the
Cingal injection.
About the FDA Requirements for Cingal
NDA
The FDA previously advised Anika that it considers
Cingal to be a drug-drug combination product that must meet the
FDA’s fixed combination rule and thus demonstrate the contribution
of each component to the therapeutic effect in a single, full
factorial pivotal study. The agency has advised Anika that, because
the TH steroid component is intended to provide pain reduction over
the short-term while the HA component (Monovisc) is intended to be
long-acting, it interprets this rule as requiring that Cingal
demonstrate superior pain reduction over the two individual
components at different time points (i.e., Cingal must demonstrate
superiority on both the comparison to HA in the short term and the
comparison to TH steroid in the long term) to support the intended
treatment effect. As noted above, in combination, Anika’s Phase III
program has now demonstrated superiority of Cingal over each of its
active ingredients and placebo. Based on these data, Anika intends
to engage with the FDA in the coming months on next steps for U.S.
regulatory approval.
About Anika
Anika Therapeutics, Inc. (NASDAQ: ANIK), is a
global joint preservation company that creates and delivers
meaningful advancements in early intervention orthopedic care.
Leveraging our core expertise in hyaluronic acid and implant
solutions, we partner with clinicians to provide minimally invasive
products that restore active living for people around the world.
Our focus is on high opportunity spaces within orthopedics,
including osteoarthritis pain management, regenerative solutions,
sports medicine soft tissue repair and bone preserving joint
technologies, and our products are efficiently delivered in key
sites of care, including ambulatory surgery centers. Anika’s global
operations are headquartered outside of Boston, Massachusetts. For
more information about Anika, please visit www.anika.com.
ANIKA, ANIKA THERAPEUTICS, CINGAL, MONOVISC, and
the Anika logo are registered trademarks of Anika Therapeutics,
Inc. or its subsidiaries.
Forward-Looking Statements
This press release may contain forward-looking
statements, within the meaning of Section 27A of the Securities Act
of 1933, as amended, and Section 21E of the Securities Exchange Act
of 1934, as amended, concerning the Company's expectations,
anticipations, intentions, beliefs or strategies regarding the
future which are not statements of historical fact, including
statements about the results of the three completed Phase III
clinical studies of Cingal (including Study 19-01), the clinical
benefits and safety profile of Cingal, the timing and outcome of a
planned meeting with the FDA about the U.S. regulatory pathway for
Cingal, the U.S. regulatory pathway generally, including the need
for additional Phase III pivotal studies, and, if approved, the
commercialization of this product candidate. The FDA may require
that the Company conduct a single, full factorial pivotal study of
Cingal confirming the clinical results observed in the Phase III
clinical trials completed to date prior to any regulatory
submission for approval. These statements are based upon the
current beliefs and expectations of the Company's management and
are subject to significant risks, uncertainties, and other factors.
The Company's actual results could differ materially from any
anticipated future results, performance, or achievements described
in the forward-looking statements as a result of a number of
factors including, but not limited to, (i) the Company's ability to
successfully commence and/or complete clinical trials of its
products on a timely basis or at all; (ii) the Company's ability to
obtain pre-clinical or clinical data to support domestic and
international pre-market approval applications, 510(k)
applications, or new drug applications, or to timely file and
receive FDA or other regulatory approvals or clearances of its
products; (iii) that such approvals will not be obtained in a
timely manner or without the need for additional clinical trials,
other testing or regulatory submissions, as applicable; (iv) the
Company's research and product development efforts and their
relative success, including whether we have any meaningful sales of
any new products resulting from such efforts; (v) the cost
effectiveness and efficiency of the Company's clinical studies,
manufacturing operations, and production planning; (vi) the
strength of the economies in which the Company operates or will be
operating, as well as the political stability of any of those
geographic areas; (vii) future determinations by the Company to
allocate resources to products and in directions not presently
contemplated; (viii) the Company's ability to successfully
commercialize its products, in the U.S. and abroad; (ix) the
Company's ability to provide an adequate and timely supply of its
products to its customers; and (x) the Company's ability to achieve
its growth targets. Additional factors and risks are described in
the Company's periodic reports filed with the Securities and
Exchange Commission, and they are available on the SEC's website at
www.sec.gov. Forward-looking statements are made based on
information available to the Company on the date of this press
release, and the Company assumes no obligation to update the
information contained in this press release.
For Investor Inquiries:
Mark NamaroffAnika Therapeutics, Inc.Vice
President, Investor Relations, ESG and Corporate
CommunicationsDirect: 781-457-9287mnamaroff@anika.com
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