Spine BioPharma, Inc., a New York-based company involved in developing non-opiate, non-surgical therapies for the treatment of pain related disabilities, announced on Wednesday, July 10, that it has signed an agreement with Korea-based Ensol BioSciences.

The contract has been signed to expand the indications (treatment scope) of Spine BioPharma's therapeutic drug treatment candidate, SB-01 For Injection.

The agreement, valued at a total of USD155 million, grants Spine BioPharma the exclusive rights to develop and commercialise SB-01 For Injection, for all additional indications beyond spine-related diseases, such as Osteoarthritis, fibrotic diseases, and Oncological indications.

Marc Viscogliosi, Spine BioPharma CEO, said, 'We are very pleased to have finalised this agreement with Ensol BioSciences, and excited about the future portfolio expansion opportunities it provides, beyond spine-related diseases. This agreement, coupled with the anticipated conclusion of the SB-01 Phase 3 MODEL Study enrolment, certainly broadens Spine BioPharma's strategic framework considerations to address the unmet needs of patients suffering from pain related disabilities, and beyond.'

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Spine BioPharma, Inc. Announces Agreement with Ensol BioSciences, Inc. to Expand Indications for SB-01 For Injection

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Spine Biopharma, Inc Jul 10, 2024, 09:00 ET

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NEW YORK, July 10, 2024 /PRNewswire/ -- Spine BioPharma, Inc., a company committed to developing non-opiate, non-surgical therapies for the treatment of pain related disabilities, today announced that it has signed an agreement with Korean Company Ensol BioSciences, Inc. to expand the indications (treatment scope) of its therapeutic drug treatment candidate, SB-01 For Injection.

The agreement, valued at a total of $155 million, grants Spine BioPharma the exclusive rights to develop and commercialize SB-01 For Injection, for all additional indications beyond spine-related diseases, such as Osteoarthritis, fibrotic diseases, and Oncological indications.

In 2018, Spine BioPharma acquired the right to develop and commercialize SB-01 For Injection globally excluding Korea, from South Korean pharmaceutical and chemical company, Yuhan Corporation (who had originally licensed it from Ensol BioSciences). Spine BioPharma is currently conducting its SB-01 Phase 3 MODEL Study (Moderate – Severe Degenerative Disc Disease Evaluation of the Lumbar Spine), the first intradiscal pharmacologic treatment to enter Phase 3 studies for the treatment of pain-related disability, associated with Degenerative Disc Disease (DDD) and anticipates completing trial enrollment of the 400-patient study in September 2024. (Clinicaltrials.gov: NCT05516992).

Marc Viscogliosi, CEO of Spine BioPharma, stated, "We are very pleased to have finalized this agreement with Ensol BioSciences, and excited about the future portfolio expansion opportunities it provides, beyond spine-related diseases. This agreement, coupled with the anticipated conclusion of the SB-01 Phase 3 MODEL Study enrollment, certainly broadens Spine BioPharma's strategic framework considerations to address the unmet needs of patients suffering from pain related disabilities, and beyond".

About SB-01 For Injection

SB-01 is a 7-amino acid synthetic peptide that binds to and antagonizes TGF-Beta. TGF-Beta is a pleiotropic cytokine expressed by almost every tissue and cell type, is stored in abundance in the extracellular matrix, and possesses suppressive and stimulatory signaling pathways. In many diseases, there are high concentrations of TGF-Beta that result in a spectrum of negative downstream effects including inflammation, fibrosis, hypertension, neoinnervation, hyperexcitability of nerves and cell proliferation. SB-01 modulates TGF-Beta concentration, without eliminating it, mitigating the negative downstream effects. Considering this mechanism of action, SB-01 has potential in the treatment of other diseases beyond degenerative disc disease including osteoarthritis, fibrotic diseases, and other significant unmet medical needs.

About Spine BioPharma

Spine BioPharma is committed to developing non-surgical/non-opioid treatments that will reduce pain, restore function, and slow or stop pathological disease progression. Spine BioPharma's lead candidate, SB-01 For Injection, is a first-in-class treatment of degenerative disc disease, offering potential clinical benefits of pain relief, restoration of function, and prevention of disease progression. To learn more about Spine BioPharma, visit www.spinebiopharma.com.

Contact:

Jason Gallagher

Chief Commercial Officer & Chief Operating Officer

jgallagher@spinebiopharma.com

Office phone: (212) 583-9700

SOURCE Spine Biopharma, Inc

Source: https://www.prnewswire.com/news-releases/spine-biopharma-inc-announces-agreement-with-ensol-biosciences-inc-to-expand-indications-for-sb-01-for-injection-302192695.html

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