Spine BioPharma Completes Series B Financing
Published March 28, 2022
Proceeds Will Support Clinical Advancement of SB-01 For Injection for Treatment of Degenerative Disc Disease
Spine BioPharma, Inc., a biopharmaceutical company committed to developing non-opiate, non-surgical therapies for the treatment of pain and disability from chronic low back pain caused by degenerative disc disease, today announced the completion of a $13 million Series B equity financing. Existing investors Viscogliosi Bros., LLC, Cercano Management, Pacira Biosciences and others participated in the financing. The company intends to use the financing to support further development of SB-01 For Injection “SB-01” (formerly referred to as Remedisc™), a first-in-class therapeutic for the treatment of degenerative disc disease.
“We are delighted to continue to benefit from the financial support and expertise of our distinguished investor-partners, said Spine BioPharma CEO Marc Viscogliosi, “This Series B financing speaks to their confidence in our company, and it will help drive the research and development of SB-01, a unique therapeutic that offers a potential non-opiate, non-surgical treatment option to chronic low back pain patients.”
SB-01 is a 7-amino acid chain peptide that binds to and induces down regulation of transforming growth factor, beta 1 (TGFβ1), which is often highly expressed in the degenerated discs of patients with lower back pain. Overexpression of TGFβ1 signaling is associated with inflammation and the degradation of extracellular matrix which maintains the structural integrity of healthy spinal discs. TGFβ1 also stimulates the expression of nerve growth factor, leading to an increase in sensory neurons and discogenic pain. SB-01 treatment of a diseased disc antagonizes the overexpression of TGFβ1, which decreases inflammation and supports the production of extracellular matrix, maintaining the structural integrity of the disc, decreasing pain and improving pain related disability.
Jee Look, senior director of drug product development with Emergent BioSolutions, says he's seen an exponential increase in demand for the company's lyophilization services in two distinct areas: the manufacturing of new biologic drugs and injectable formulation; and change of formulation presentation from frozen to lyophilized presentation, as clinical trials progress from phase 1 to phase 2/3 and commercial manufacturing.
In the case of Spine BioPharma, for example, Look says lyophilization allowed for ease in storing, distributing and handling the product. "The biological drug substance is typically not stable at 2-8°C. By converting to an appropriate lyophilized form, it will significantly enhance the drug substance stability," says Look.
Intradiscal injection of SB-01 in patients with degenerative disc disease (DDD) was developed as a first-in-class pharmacological approach to treating chronic back pain, while potentially preventing progression of disc degeneration through TGFβ1 modulation.
McDermott, Will & Emery, LLP is acting as legal advisor to Spine BioPharma in connection with the transaction.
About Degenerative Disc Disease
Approximately 266 million individuals around the world experience degenerative disc disease (DDD), and its associated chronic low back pain each year. DDD of the lumbar, or lower, spine is a significant cause of disability in the world and a tremendous expense to the healthcare system. It is associated with a variety of clinical symptoms, including, weakness, low back pain and disability of varying levels of severity. There is currently no treatment for the underlying cause of DDD and current approaches are aimed at managing pain through a variety of approaches that include physical therapy, chiropractic care, over the counter medications like non-steroidal anti-inflammatory drugs (NSAIDS) or prescription opioids. For patients with moderate to severe pain that persists chronically, treatment plans include epidural steroid injections, nerve blocks, radiofrequency ablation or surgical intervention. Clinical outcomes vary and often do not provide predictable benefit. Given the substantial costs, pain, and disability associated with DDD, and the current lack of an approved therapy that could relieve pain and increase function with the potential to mediate the progression of DDD or achieve a regenerative effect could revolutionize the standard of care.
About Spine BioPharma
Spine BioPharma specializes in non-surgical therapies that will reduce pain, restore function and slow or stop pathological spinal disease progression without the use of opioids. Spine BioPharma’s lead candidate, SB-01, is a first-in-class, therapeutic for the treatment of degenerative disc disease, offering clinical benefits of pain relief, restoration of function and potential prevention of disease progression. SB-01 has also been referred to YH14618 by Yuhan Corp. and P2K by Ensol Biosciences.