rexlemestrocel intradiscal (MPC-06-ID) / Mesoblast, Grunenthal - LARVOL DELTA

Mesoblast Reports Financial Results and Operational Update for Fiscal Year Ended June 30, 2023 (GlobeNewswire) - "Product has been manufactured for use in a pivotal study recruiting patients across the United States to support potential marketing approval of rexlemestrocel-L in chronic low back pain (CLBP) due to degenerative disc disease. Pivotal trial start-up activities have commenced and recruitment is expected to begin next quarter. Primary endpoint is reduction in pain at 12 months compared to placebo."

Commercial • New trial • Back Pain • CNS Disorders • Lumbar Back Pain • Musculoskeletal Pain • Pain

Mesoblast Completes Private Placement - April 26, 2023 (BioSpace) - "Mesoblast Limited...today announced it has completed a global private placement primarily to Mesoblast’s existing major US, UK, and Australian shareholders raising approximately US$40 million, net of transaction costs, at A$0.85 per share. Proceeds will be used to fund: Launch and commercialization of the company’s lead product, remestemcel-L, in the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD)....Ongoing manufacturing of commercial remestemcel-L product at the Lonza Biosciences facility in Singapore, where the upcoming scheduled pre-licensure inspection (PLI) will be performed by FDA. Initiation of patient enrolment in the confirmatory Phase 3 clinical trial of rexlemestrocel-L for chronic low back pain associated with degenerative disc disease."

Financing • Acute Graft versus Host Disease • Back Pain • CNS Disorders • Graft versus Host Disease • Immunology • Lumbar Back Pain • Musculoskeletal Pain • Pain

Single Dose of Mesoblast’s Allogeneic Cell Therapy Provides Durable Pain Reduction for at Least Three Years in Patients With Degenerative Disc Disease (GlobeNewswire) - P3, N=404; NCT02412735; Sponsor: Mesoblast, Ltd; "Mesoblast Limited...today announced 36-month follow-up results from the 404-patient Phase 3 trial of its allogeneic cell therapy rexlemestrocel-L (MPC-06-ID) in patients with chronic low back pain (CLBP) associated with degenerative disc disease (DDD). Mesoblast Chief Executive Dr Silviu Itescu presented results from the three-arm trial at the 2022 Biotech Showcase event being held this week....Results presented from this trial showed that...Durable reduction in pain through 36 months was greatest in the pre-specified population with CLBP of shorter duration than the study median of 68 months (n=194)...Pain reduction through 36 months was also seen in the subset of patients using opioids at baseline (n=168) with the rexlemestrocel-L+HA group having substantially greater reduction at all time points compared with saline controls..."

P3 data • Back Pain • CNS Disorders • Lumbar Back Pain • Pain

Will Mesoblast's Heart Failure & Chronic Low Back Pain Trial Data Readouts Be Heartening Or Painful? (Nasdaq) - "Another product candidate in the pipeline, which is also under a phase III trial, is MPC-06-ID for chronic low back pain in 404 patients. The final study visits for all patients have been completed....Data readout from the MPC-06-ID trial is also due this quarter."

Trial completion • Back Pain • CNS Disorders • Pain

MESOBLAST REPORTS SUBSTANTIAL OPERATIONAL PROGRESS AND FINANCIAL RESULTS FOR THE YEAR ENDED JUNE 30, 2020 (Mesoblast Press Release) - "Rexlemestrocel (MPC-06-ID) for Chronic Low Back Pain:...Data readout for the 2:1 randomized placebo-controlled US Phase 3 trial in 404 patients is expected during Q4 CY2020. Mesoblast continues to collaborate closely with Grünenthal on the clinical protocol for a confirmatory Phase 3 trial in Europe for MPC-06-ID in chronic low back pain due to degenerative disc disease, with the results of this and the US Phase 3 trial expected to support both FDA and European Medicines Agency regulatory approvals."

New P3 trial • P3 data • Back Pain • Pain

Mesoblast (ASX:MSB) gets closer to lead drug approval (The Market Herald) - "Results from the phase three trial for chronic lower back pain is expected by the end of the year. Additionally, Mesoblast and its partner Grünenthal GmbH are collaborating for a confirmatory phase three trial in Europe."

P3 data • Back Pain • Pain

Mesoblast Shares Halted: A Look At The Biopharma's Upcoming Catalysts (Benzinga) - "The company is also due to report results in the fourth quarter from...analysis of data from a Phase 3 trial in MPC-06-ID for chronic low back pain."

P3 data • Back Pain • CNS Disorders • Pain

Grünenthal and Mesoblast enter strategic partnership for Europe and Latin America to develop and commercialise innovative cell therapy for the treatment of chronic low back pain (GlobeNewswire) - "Grünenthal...and Mesoblast Limited...today announced that they have entered into a strategic partnership to develop and commercialise MPC-06-ID, a Phase III allogeneic cell therapy candidate for the treatment of chronic low back pain due to degenerative disc disease in patients who have exhausted conservative treatment options. Under the partnership, Grünenthal will have exclusive commercialisation rights to MPC-06-ID for Europe and Latin America....Mesoblast is completing a Phase III trial for MPC-06-ID in the U.S. which will read out in 2020."

Licensing / partnership • Trial status