Drug for Osteoarthritis Jockeys for Approval

TissueGene, Inc. has reached an agreement with the FDA regarding a Special Protocol Assessment (SPA) of the design and statistical analysis plan for a Phase 3 clinical trial. The trial will be of Invossa, an allergenic therapy for osteoarthritis of the knee.

A Special Protocol Assessment is a procedure by which the FDA provides official evaluation and written guidance on the design and size of proposed protocols that are to form the basis for a new drug application.

In a letter dated May 15, 2015, the FDA wrote TissueGene executives, “”[W]e have determined that the design and planned analyses of your study sufficiently address the study’s objectives and that this study is adequately designed to provide the necessary data that, depending upon outcome, could support a license application submission for drug approval.”

The double-blinded randomized controlled trial will enroll approximately 1, 020 patients with osteoarthritis of the knee. Patients will receive an injection of either Invossa or a placebo. The trial is designed to evaluate improvement in knee function, pain and disease modification as measured by joint space width.

TissueGene President and CEO Woosok Lee commented, “The SPA agreement is a major milestone for us as it represents the first clearly defined development and regulatory pathway for the approval of Invossa for the treatment of osteoarthritis of the knee.” Lee said that if the approvals come through, Invossa would be the first disease modifying osteoarthritis drug marketed for the treatment of osteoarthritis of the knee.

Approval by the Korean Ministry of Food and Drug Safety is expected later this year. “We anticipate commercialization of Invossa by early next year in Korea and look forward to its expansion in the Asian market, ” said Lee. There are an estimated 9 million Americans suffering from osteoarthritis of the knee, making it one of the leading causes of disability in the United States.