Superior Results Reported in Anika Therapeutics’ Cartilage Repair Scaffold Study

Anika Therapeutics Inc. is touting topline results from its U.S. pivotal clinical trial of Hyalofast, a resorbable, hyaluronic acid scaffold used in conjunction with autologous bone marrow aspirate concentrate (BMAC) for cartilage repair. Enrollment for this trial was completed in 2023 and the results follow the recently completed, evaluator-blinded two-year follow-up period post-treatment.

Begun in 2015, FastTRACK is a prospective, randomized, active treatment-controlled evaluator-blinded multicenter study designed to establish the superiority of Hyalofast with autologous BMAC in treating articular knee cartilage defect lesions compared to a microfracture control (an active comparator). Superiority between the groups was to be determined with two pre-specified co-primary endpoints: percent change from baseline to two years in both Knee injury and Osteoarthritis Outcomes Score (KOOS) pain and International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score (a measure of function).

While Hyalofast showed consistent improvements in treated patients across all measures of pain and function relative to microfracture, the study did not meet its pre-specified co-primary endpoints. The trial was likely impacted by both a higher subject dropout rate in the microfracture arm and missed visits during COVID-19. As a result, there was missing data, which reduced the evaluable sample size and complicated the statistical analysis. Hyalofast exhibited a comparable safety profile when compared to microfracture following the initial effects of the differences in surgical procedure, supporting a favorable benefit-risk profile for Hyalofast.

Based on all the clinical data the company has collected on Hyalofast, Anika plans to file a final PMA module by the end of the year. Hyalofast showed statistically significant improvements in key pre-defined secondary endpoints including KOOS Sports and Recreation Function, and Quality of Life. In addition, Hyalofast demonstrated statistically significant improvement in Total KOOS, a composite pain and function measure. These additional measures have supported prior U.S. Food and Drug Administration (FDA) approvals for cartilage repair products.

Hyalofast has been used outside the United States to successfully treat more than 35,000 patients since its launch in 2009 and is currently available in more than 35 countries. Hyalofast has demonstrated a favorable safety and effectiveness profile from this real-world clinical experience across multiple independent studies performed outside the United States, including positive 15-year outcomes published last year.

“While we are disappointed that the co-primary endpoints were not achieved under the original statistical framework, we are encouraged by the consistency and robustness of our results on pain and function measures including achieving significance on measures used for prior FDA cartilage repair approvals and the published global evidence supporting the safety and effectiveness of Hyalofast. We believe the totality of evidence presented in this study and the data from outside the U.S. demonstrates the true clinical value of Hyalofast, a single stage procedure, for patients who suffer from cartilage lesions in the knee,” Anika Therapeutics President/CEO Cheryl Blanchard said.

Anika’s third PMA module will include ongoing additional post-hoc analyses including consideration of additional endpoints previously accepted by the FDA for cartilage repair product approvals. Anika expects the FDA to consider these additional post-hoc analyses and the additional data from outside the United States as part of its review of the PMA submission under its Breakthrough Device Designation, but whether these analyses are sufficient to support approval will be a review issue.

Hyalofast is Anika’s single-stage, off-the-shelf, resorbable, hyaluronic acid scaffold for cartilage repair. It supports the regeneration of hyaline-like cartilage and has demonstrated its safety and effectiveness in multiple clinical trials. Hyalofast has been designated as a breakthrough device by the FDA, allowing prioritized interaction and review.

Anika Therapeutics designs, develops, manufactures, and commercializes hyaluronic acid innovations. In partnership with clinicians, its sole focus is delivering and advancing osteoarthritis pain management and orthopedic regenerative solutions. Anika’s global operations are headquartered outside of Boston.