Symic Bio announced the treatment of the first patient in the MODIFY2 Phase 2 clinical trial investigating SB-061 for pain management in mild-to-moderate osteoarthritis of the knee. The initiation of the 12-week, multicenter, double-blinded trial of approximately 60 patients follows previously announced Phase 1/2a clinical results supporting the safety, tolerability and intended mechanism of action of SB-061. In addition, Symic Bio plans to conduct a concurrent magnetic resonance imaging study, MODIFY-MRI, to assess the short-term physical modifications of the disease process resulting from SB-061 treatment. The MODIFY-MRI study includes an assessment of the process of inflammation, intended to provide data that are critical in further defining the potential for SB-061 to act as a long-term disease-modifying agent.

"We are encouraged by the performance of SB-061 in the clinic thus far," said Nathan Bachtell, M.D., Chief Medical Officer of Symic Bio. "By addressing the degradation of cartilage that is fundamental to disease pathology, SB-061 is intended to both manage pain and modify the course of disease. We are looking forward to efficacy results and MRI imaging data and expect to provide a top-line analysis of MODIFY2 and MODIFY-MRI results in early 2018."

In the osteoarthritis disease state, the primary proteoglycan in the cartilage extracellular matrix, aggrecan, is degraded and lost. With the loss of aggrecan, cartilage is vulnerable to pro-inflammatory cytokines that cause degradation, leading to additional breakdown of the extracellular matrix in the joint. SB-061, a therapeutic bioconjugate inspired by aggrecan, is a drug delivered directly to the joint via an intra-articular injection. SB-061 directly targets the degrading extracellular matrix, thereby reducing the inflammatory cycle that drives the signs and symptoms of progressive osteoarthritis. The goal of this approach is to modify the course of disease by reducing joint degradation and concurrently decreasing pain and functional decline due to inflammation in the joint.

For more information on the MODIFY2 Phase 2 trial for osteoarthritis of the knee, please see https://clinicaltrials.gov/ct2/show/NCT03231280.