Remedisc (SB-01) / Yuhan Corp, Spine Biopharma, Ensol Biosci - LARVOL DELTA

MODEL: Moderate - Severe Degenerative Disc Disease Evaluation of the Lumbar Spine (clinicaltrials.gov) - P3 | N=417 | Active, not recruiting | Sponsor: Spine BioPharma, Inc | Recruiting ➔ Active, not recruiting

Enrollment closed • Musculoskeletal Diseases

Spine BioPharma, Inc. Announces Completion of Enrollment for Phase 3 Clinical Trial of SB-01 to Address Chronic Low Back Pain (Businesswire) - "Spine BioPharma...announced the completion of enrollment of its U.S. Phase 3 clinical trial of SB-01 For Injection (SB-01). The Phase 3 MODEL trial (MOderate - Severe Degenerative Disc Disease Evaluation of the Lumbar Spine) enrolled 417 patients at 30 investigational sites across the U.S., in a two-year period. SB-01 is the first intradiscal pharmacologic treatment to enter Phase 3 studies for the treatment of chronic low back pain (CLBP) and its associated pain-related loss of function caused by DDD."

Enrollment closed • Back Pain • Lumbar Back Pain

MODEL: Moderate - Severe Degenerative Disc Disease Evaluation of the Lumbar Spine (clinicaltrials.gov) - P3 | N=400 | Recruiting | Sponsor: Spine BioPharma, Inc | Trial completion date: Jun 2024 ➔ Jun 2025 | Trial primary completion date: Dec 2023 ➔ Dec 2024

Trial completion date • Trial primary completion date • Musculoskeletal Diseases

Spine BioPharma Announces First Patient Treated in U.S. Phase 3 Clinical Study (PRNewswire) - "Spine BioPharma...today announced the first patient treated in a Phase 3 clinical study of SB-01 For Injection (SB-01). The SB-01 Phase 3 study is known as the MODEL Study (Moderate – Severe Degenerative Disc Disease Evaluation of the Lumbar Spine). SB-01 is the first intradiscal pharmacologic treatment to enter Phase 3 studies for the treatment of pain-related disability, associated with DDD."

Trial status • Back Pain • CNS Disorders • Lumbar Back Pain • Pain

Developed Ensol Bioscience’s ‘degenerative disc treatment’ FDA phase 3 administration [Google translation] (Money Today) - "The U.S. Food and Drug Administration (FDA) recently started a phase 3 clinical trial for a degenerative disc treatment for which there is no fundamental treatment....Ensol Bioscience announced on the 1st that the first patient in phase 3 clinical trials of the degenerative disc treatment P2K (SB-01) developed by Ensol Bioscience was recently administered to patients. P2K was developed by Ensol Bioscience and technology transfer was made through Yuhan's domestic phase 2 clinical trial. Spine Biopharma, who is leading the FDA's Phase 3 clinical trial, thoroughly analyzed Yuhan's phase 2 clinical data and conducted the best clinical design to ensure success, Ensol Bio explained."

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

MODEL: Moderate - Severe Degenerative Disc Disease Evaluation of the Lumbar Spine (clinicaltrials.gov) - P3 | N=400 | Recruiting | Sponsor: Spine BioPharma, Inc

New P3 trial • Musculoskeletal Diseases

Spine BioPharma Initiating U.S. Phase 3 Clinical Study (PRNewswire) - "Spine BioPharma, Inc...today announced the receipt of a U.S. Food and Drug Administration (FDA) Study May Proceed Letter authorizing the Company to proceed with a Phase 3 clinical study of SB-01 For Injection (SB-01). SB-01 is the first pharmacologic treatment to enter Phase 3 studies for the treatment of pain-related disability, associated with DDD."

FDA event • New P3 trial • Back Pain • CNS Disorders • Lumbar Back Pain • Musculoskeletal Pain • Pain

Clinical Trial of YH14618 in Patients With Degenerative Disc Disease (clinicaltrials.gov) - P2b; N=326; Active, not recruiting; Sponsor: Yuhan Corporation; Phase classification: P2 ➔ P2b

Phase classification • Biosimilar • Pain