SB-061 / SYMIC Bio - LARVOL DELTA

BMI Impacts Patient-Reported Symptoms and Functional Tests in a Knee Osteoarthritis Trial (OBESITY WEEK 2025) - " This is a post-hoc analysis of a randomized, placebo-controlled, double-blind Phase II study comparing intra-articular injections of SB-061 with placebo (isotonic saline) over 52 weeks... Placebo injections improved the 20-meter walking test and PROMs, including WOMAC, ICOAP, and PGA scores, but the degree of improvement varied across BMI categories. PROMs appeared more sensitive to placebo injections than functional performance metrics like the 20-meter walking test. Notably, BMI remained stable over time and did not act as a confounding factor for the 20-meter walking test or PROMs, and did not influence biomarkers, blood pressure, or pulse fluctuations."

Clinical • Genetic Disorders • Immunology • Musculoskeletal Pain • Obesity • Osteoarthritis • Pain • Rheumatoid Arthritis • Rheumatology • ACAN

The impact of BMI on placebo response in patient-reported symptoms and functional tests in a knee osteoarthritis trial (ECO 2025) - " This is a post-hoc analysis of a randomized, placebo-controlled, double-blind Phase II study comparing intra-articular injections of SB-061 with placebo (isotonic saline) over 52 weeks¹... Baseline characteristics across BMI subgroups were comparable on age, KL-score and with no significant differences in any of the main analysis parameters. Greater variability was observed in the 20-meter walking test compared to PROMs assessing pain, stiffness, and functionality, as measured by WOMAC, PGA, and ICOAP scores (Figure 1). After 52 weeks of intervention, significant reductions in duration and step count for the 20-meter walking test were observed in BMI ranges 30–35 (p < 0.0001, p = 0.004) and 40–45 (p = 0.0014, p = 0.36), respectively, compared to baseline."

Clinical • Genetic Disorders • Immunology • Musculoskeletal Pain • Obesity • Osteoarthritis • Pain • Rheumatoid Arthritis • Rheumatology

A Phase 2b double-blind placebo-controlled randomized clinical trial of SB-061, an aggrecan mimetic, in patients with symptomatic knee osteoarthritis. (PubMed, Osteoarthritis Cartilage) - P2 | "Intra-articular injections of SB-061 administered at baseline, Wk 16, and Wk 32, over one year in subjects with knee OA was safe but did not show any statistically significant effect on knee pain nor on other symptomatic or structural entities compared to placebo."

Clinical • Journal • P2b data • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology • ACAN

A Phase 2b double-blind placebo-controlled randomized clinical trial of SB-061, an aggrecan mimetic, in subjects with symptomatic knee osteoarthritis (EULAR 2023) - P2 | "SB-061 was well-tolerated. Conclusion Intra-articular injections of SB-061 administered quarterly for one year in patients with knee OA was safe but did not show any statistically significant effect on knee pain nor on other symptomatic or structural entities compared to placebo."

Clinical • P2b data • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology • ACAN

SB-061 for the Treatment of Symptomatic Osteoarthritis of the Knee (clinicaltrialsregister.eu) - P2; N=278; Ongoing; Sponsor: Nordic Bioscience Clinical Development A/S

New P2 trial