Spine BioPharma and Ensol BioSciences to Expand SB-01 Injection Indications

NEW YORK, July 10, 2024 - Spine BioPharma, Inc., a company focused on developing non-opiate, non-surgical therapies for pain-related disabilities, has announced a new agreement with Korean firm Ensol BioSciences, Inc. This agreement aims to broaden the application of its drug candidate, SB-01 For Injection.

Under the terms of the $155 million agreement, Spine BioPharma gains exclusive rights to develop and market SB-01 For Injection for a range of conditions beyond spine-related diseases. These new indications include Osteoarthritis, fibrotic diseases, and oncological conditions. In 2018, Spine BioPharma initially acquired the global development and commercialization rights for SB-01 For Injection, excluding Korea, from Yuhan Corporation, who originally licensed the drug from Ensol BioSciences.

Spine BioPharma is currently conducting a Phase 3 clinical trial named the MODEL Study, which stands for Moderate – Severe Degenerative Disc Disease Evaluation of the Lumbar Spine. This study is the first to investigate an intradiscal pharmacologic treatment for pain-related disability due to Degenerative Disc Disease (DDD) and aims to complete the enrollment of its 400 patients by September 2024.

Marc Viscogliosi, CEO of Spine BioPharma, expressed his enthusiasm about the agreement with Ensol BioSciences, highlighting the significant expansion opportunities it presents beyond spine-related diseases. He noted that this agreement, along with the anticipated completion of the SB-01 Phase 3 MODEL Study, broadens the company's strategic considerations to better address the needs of patients suffering from various pain-related disabilities.

SB-01 For Injection is a synthetic peptide composed of seven amino acids that antagonizes TGF-Beta, a cytokine found in almost all tissues and cell types. TGF-Beta has both suppressive and stimulatory signaling pathways and is stored in large amounts in the extracellular matrix. High concentrations of TGF-Beta are associated with a range of negative effects, including inflammation, fibrosis, hypertension, nerve hyperexcitability, and cell proliferation. SB-01 works by modulating the concentration of TGF-Beta, reducing its adverse downstream effects without completely eliminating the cytokine. This mechanism makes SB-01 a promising candidate for treating not only degenerative disc disease but also other conditions such as osteoarthritis and fibrotic diseases.

Spine BioPharma is dedicated to developing treatments that are both non-surgical and non-opioid, aiming to alleviate pain, restore functionality, and slow or halt disease progression. Their leading candidate, SB-01 For Injection, is positioned as a first-in-class treatment for degenerative disc disease, offering potential benefits such as pain relief, functional restoration, and disease progression prevention.