Anika Therapeutics Announces Top-Line Results from CINGAL 16-02 Clinical Trial in Knee Osteoarthritis
June 19 2018 - 3:05PM
Business Wire
CINGAL 16-02 study did not achieve statistical
significance at primary endpoint of 26 weeks in active comparator
study; Company committed to working closely with regulators to gain
U.S. approval
Strong pain reduction and overall symptom
relief consistent with statistically significant results of CINGAL
13-01 Phase III placebo-controlled clinical study
Anika Therapeutics, Inc. (NASDAQ: ANIK), a global, integrated
orthopedic and regenerative medicines company specializing in
therapeutics based on its proprietary hyaluronic acid (HA)
technology platform, today announced results from its CINGAL® 16-02
clinical trial, an active-comparator Phase III study being
conducted to support U.S. registration. CINGAL has previously been
evaluated in a placebo-controlled Phase III clinical trial (13-01)
that demonstrated safety and efficacy through 26-weeks. The 16-02
trial compared CINGAL, a combination of cross-linked HA and
triamcinolone hexacetonide (TH), with TH alone and cross-linked HA
in treating patients with osteoarthritis (OA) in the knee. The
primary endpoint was a comparison of the pain reduction of CINGAL
compared with TH alone at 26-weeks. While CINGAL achieved greater
pain reduction numerically at every time point in the study, the
difference at 26-weeks did not reach statistical significance.
The patient response to CINGAL in the study was strong, as
significant improvements in pain, function, and quality of life
were observed at levels consistent with, and in most cases greater
than, the results of the 13-01 placebo-controlled Phase III study
of CINGAL. A strong safety profile was also shown, matching
previous clinical studies as well as real-world experience from
growing product use globally. The duration of pain reduction was
also similar to the previous study as patient improvement after
CINGAL injection was maintained near peak levels throughout the
26-week duration of the study. Follow-up of patients continues in a
prospectively designed extension phase to the study, which will
gather data through 39-weeks.
Prof. Laszlo Hangody, MD, Ph.D., DSc., the global principal
investigator of several CINGAL trials, said, “While it has been
observed that TH has a longer duration of effect than other
corticosteroids, the results in this study were surprising.
Nevertheless, the patient response to CINGAL in this study was
strong as patients received statistically and clinically meaningful
rapid and long-lasting improvement in symptoms compared with
base-line, consistent with the previous study as well as my
experience in my practice. Taken together, the results of the two
Phase III studies validate the effectiveness of this novel
combination for use in patients with knee osteoarthritis.”
CINGAL is the first and only commercially-available combination
viscosupplement, and it is currently being used successfully by
physicians to provide rapid and long-lasting relief from pain and
discomfort caused by OA for patients in a growing number of
countries. CINGAL is a patented formulation composed of the
Company’s proprietary cross-linked sodium hyaluronate and
triamcinolone hexacetonide. CINGAL is Anika’s third-generation
viscosupplement, following the Company’s ORTHOVISC and MONOVISC
products, to treat pain associated with osteoarthritis of the
knee.
Anika President and CEO Joseph Darling said, “OA patients
continue to benefit from the proven safety and efficacy of CINGAL
in growing numbers outside of the U.S. where CINGAL is approved.
The benefits of combining HA and a corticosteroid are mirrored by
physician feedback and real-world experience. While we expected
CINGAL to perform as well as it did, we were surprised that the
difference in pain reduction seen in this trial did not reach
statistically significant levels at six months. We will however,
continue to monitor the results of the ongoing 3-month extension
study. We are actively reviewing the data and our plan is to work
closely with regulators to come to an understanding of the next
steps required to gain U.S. regulatory approval of CINGAL. We
remain fully committed to bringing this impactful OA solution to
U.S. patients and physicians.”
About Anika Therapeutics, Inc.
Anika Therapeutics, Inc. is a global, integrated orthopedic and
regenerative medicines company based in Bedford, Massachusetts.
Anika is committed to improving the lives of patients with
degenerative orthopedic diseases and traumatic conditions with
clinically meaningful therapies along the continuum of care, from
palliative pain management to regenerative tissue repair. The
Company has over two decades of global expertise developing,
manufacturing, and commercializing more than 20 products based on
its proprietary HA technology. Anika's orthopedic medicine
portfolio includes ORTHOVISC, MONOVISC, and CINGAL, which alleviate
pain and restore joint function by replenishing depleted HA, and
HYALOFAST, a solid HA-based scaffold to aid cartilage repair and
regeneration. For more information about Anika, please visit
www.anikatherapeutics.com.
ANIKA, ANIKA THERAPEUTICS, CINGAL, HYALOFAST, MONOVISC, and
ORTHOVISC are registered trademarks of Anika.
Forward-Looking Statements
The statements made in fifth paragraph of this press release as
to the future activities and plans of the Company are
forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933 and Section 21E of the Securities Exchange
Act of 1934. These statements, which reflect the current beliefs
and expectations of the Company’s management, may be affected by
inaccurate assumptions and by known and unknown risks and
uncertainties that are difficult to predict or beyond the Company's
control, including actions and decisions of regulatory authorities.
Additional factors and risks are described in the Company's
periodic reports filed with the Securities and Exchange Commission
and available at www.sec.gov. Forward-looking statements are 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.
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For Investor Inquiries: Anika Therapeutics, Inc.Sylvia Cheung,
Chief Financial Officer, 781-457-9000orFor Media Inquiries: Pure
CommunicationsSonal Vasudev, 917-523-1418
sonal@purecommunicationsinc.com
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