hyaluronic acid/rexlemestrocel-L / Mesoblast - LARVOL DELTA

Appendix 4C Quarterly Activity Report for Quarter Ended June 30, 2024 (GlobeNewswire) - "The confirmatory Phase 3 trial of...rexlemestrocel-L in patients with chronic low back pain (CLBP) due to inflammatory degenerative disc disease of less than five years duration has commenced enrollment at multiple sites across the United States. FDA has previously confirmed alignment with Mesoblast on the design of the 300-patient randomized, placebo-controlled trial and the 12-month primary endpoint of pain reduction as an approvable indication. Key secondary measures include improvement in quality of life, function, and reduced opioid usage. FDA has designated rexlemestrocel-L a Regenerative Medicine Advanced Therapy (RMAT) for the treatment of chronic low back pain."

Enrollment open • FDA event • Back Pain • CNS Disorders • Lumbar Back Pain • Pain

HyaluronicAcid: Efficacy and Safety of Rexlemestrocel-L Combined With HA* in Participants With Moderate to Severe Chronic Low Back Pain (clinicaltrials.gov) - P3 | N=300 | Recruiting | Sponsor: Mesoblast, Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Back Pain • Lumbar Back Pain • Musculoskeletal Diseases • Musculoskeletal Pain • Pain

HyaluronicAcid: Efficacy and Safety of Rexlemestrocel-L Combined With HA* in Participants With Moderate to Severe Chronic Low Back Pain (clinicaltrials.gov) - P3 | N=300 | Not yet recruiting | Sponsor: Mesoblast, Ltd.

New P3 trial • Back Pain • Lumbar Back Pain • Musculoskeletal Diseases • Musculoskeletal Pain • Pain

Mesoblast Reports Operational and Financial Highlights for Quarter Ended December 31, 2022 (GlobeNewswire) - "Research & Development expenses reduced by US$2.5 million (25%), down to US$7.7 million for the second quarter FY2023 compared to US$10.2 million for the second quarter FY2022. R&D expenses primarily supported preparations for the remestemcel-L BLA re-submission and preparations for pivotal studies for rexlemestrocel-L, as clinical trial activities for our product candidates are reduced since clinical trial recruitment and data analysis are now complete."

Commercial • Acute Graft versus Host Disease • Back Pain • CNS Disorders • Crohn's disease • Graft versus Host Disease • Immunology • Inflammatory Bowel Disease • Lumbar Back Pain • Pain • Ulcerative Colitis

FDA Grants Regenerative Medicine Advanced Therapy (Rmat) Designation for Rexlemestrocel-L in Chronic Low Back Pain (GlobeNewswire) - "Mesoblast Limited...today announced that the United States Food and Drug Administration’s (FDA) Office of Tissues and Advanced Therapies (OTAT) has granted Regenerative Medicine Advanced Therapy (RMAT) designation for rexlemestrocel-L in the treatment of chronic low back pain (CLBP) associated with disc degeneration, in combination with hyaluronic acid (HA) as delivery agent for injection into the lumbar disc."

FDA event • Back Pain • CNS Disorders • Lumbar Back Pain • Pain

MSB-DR003: Placebo-controlled Study to Evaluate Rexlemestrocel-L Alone or Combined With Hyaluronic Acid in Subjects With Chronic Low Back Pain (clinicaltrials.gov) - P3; N=404; Completed; Sponsor: Mesoblast, Ltd.; Active, not recruiting ➔ Completed

Clinical • Trial completion • Back Pain • Lumbar Back Pain • Musculoskeletal Pain • Pain

Mesoblast Phase 3 Trial Shows That a Single Injection of Rexlemestrocel-L + Hyaluronic Acid Carrier Results in at Least Two Years of Pain Reduction With Opioid Sparing Activity in Patients With Chronic Low Back Pain Due to Degenerative Disc Disease (GlobeNewswire) - P3, N=404; NCT02412735; Sponsor: Mesoblast, Ltd.; "Mesoblast...announced results from the Phase 3 randomized controlled trial of its allogeneic mesenchymal precursor cell (MPC) therapy rexlemestrocel-L in 404 enrolled patients with chronic low back pain (CLBP) due to degenerative disc disease (DDD) refractory to conventional treatments....Significant reduction in opioid use over 24 months in patients treated with MPC + HA, while increased opioid use occurred in saline controls. Treatment with MPC + HA resulted in nearly four times more opioid users achieving 50% reduction in pain as well as reduction in opioid use by 24 months than those treated with saline."

P3 data • Back Pain • Pain