Symic Bio announced topline results from the MODIFY2 Phase 2 clinical trial of SB-061 for symptom management in mild-to-moderate osteoarthritis of the knee. The 12-week, multicenter, double-blind trial of 60 patients was designed to investigate the effects of SB-061 in the overall population as well as a prespecified subpopulation of patients with knee effusions. MODIFY2 demonstrated that treatment with SB-061 was well-tolerated, with a safety profile consistent with the saline control treatment group. In patients with knee effusions, measurements of reduction in pain from baseline at 4 weeks by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain while walking score (WOMAC A1), were consistent with SB-061 treatment providing a clinically relevant degree of improvement compared to the control group, although these observations did not reach the threshold of statistical significance as the trial was designed with a small sample size.
In patients with knee effusions, the repeated measures analysis of pain reduction over 4 weeks and repeated measures analysis of pain reduction over 12 weeks were consistent with an effect of SB-061 in potentially providing a clinically meaningful degree of improvement relative to control. These observations of a potential treatment effect were maintained in the WOMAC pain and function sub-scores as well as the full WOMAC. In the overall patient population including patients with and without effusions, treatment with SB-061 did not meet the primary endpoint of demonstrating a clinically meaningful improvement compared to control.
"We are encouraged by the performance of SB-061 in the clinic thus far, especially the data in patients with effusions," said Nathan Bachtell, M.D., Chief Medical Officer of Symic Bio. "These results build upon previously announced Phase 1/2a results from the MODIFY-OA trial that supported the safety, tolerability and intended mechanism of action of SB-061. Given the biomarker results and efficacy signal seen in subjects with knee effusions in the MODIFY-OA trial, a specific cohort from this patient population which is known to have more active inflammation in the joint, the MODIFY2 trial was designated a priori to analyze this patient subset. The MODIFY2 results support that patients with effusions have a clinically meaningful response to SB-061 that can be confirmed in a study focused on patients in this population. We expect to provide additional detail at an upcoming medical conference."