Anika Therapeutics (NSDQ:ANIK) said yesterday that it enrolled the 1st patient in a supplemental Phase III efficacy and safety trial of its Cingal hyaluronic acid-corticosteroid combination viscosupplement.
The Bedford, Mass.-bsaed company is evaluating Cingal as a treatment for osteoarthritis-related knee pain.
The supplemental late-stage trial is slated to enroll patients at 30 European sites and randomize them to receive Cingal, Monovisc or triamcinolone hexacetonide. Researchers will follow the patients for 26 weeks and monitor safety as well as changes in pain, function and quality of life measures.
“Advancing Cingal towards FDA approval is 1 of our key business priorities, and the enrollment of the 1st patient in our supplemental Phase III trial is an important step towards achieving that goal,” president & CEO Charles Sherwood said in prepared remarks.
The company said it expects to finish the trial in 2018 and to win FDA approval the following year.
Cingal was the 1st viscosupplement to combine triamcinolone hexacetonide, an FDA-approved steroid, with Anika’s cross-linked hyaluronic acid, according to the company. Healthcare professionals inject viscosupplements into synovial joints to rejuvenate the natural cushioning that degrades with age and degenerative orthopedic diseases.
Earlier this week, Anika touted data from the Phase III trial that supported Cingal’s Health Canada and CE mark approvals.
The data showed that treatment with Cingal yielded better immediate and short-term pain relief compared to hyaluronic acid alone and better pain and stiffness relief through 26 weeks compared to saline.
ANIK shares were trading at $46.77 apiece in morning activity today, up 0.7%.