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
BEDFORD, Mass.--(BUSINESS WIRE)--Jun. 19, 2018--
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
About Anika Therapeutics, Inc.
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,
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.
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20180619006297/en/
Source: Anika Therapeutics, Inc.
For Investor Inquiries: Anika Therapeutics, Inc.
Chief Financial Officer, 781-457-9000
For Media Inquiries:
Sonal Vasudev, 917-523-1418 firstname.lastname@example.org