American biotechnology company Spine Biopharma announced on the 24th (local time) that it has completed the registration of patients for the phase 3 clinical trial in the US for its degenerative disc disease (DDD) treatment candidate substance ‘SB-01’. SB-01 is a new drug candidate substance for lumbar degenerative disc disease (Remedisk, Yuhan-Yanghaeng development name YH14618) that Spine Biopharma imported from domestic pharmaceutical company Yuhan-Yanghaeng.
In 2009, Yuhan-Yanghaeng introduced Remedisk (Ensol Biosciences development name P2K·Bniel 2000) technology from domestic bio company Ensol Biosciences and promoted its own development (clinical phase 1, clinical phase 2a, clinical phase 2b). In 2018, it signed a technology transfer agreement with Spine Biopharma for the development rights of candidate substances and global (excluding domestic) distribution rights. Yuhan-Yanghaeng received approximately KRW 2.7 billion in technology fees, and the total contract size according to the development stage is approximately KRW 290 billion.
SB-01 is a natural amino acid peptide compound. It has a mechanism of regulating signaling substances to relieve chronic pain and inhibit disc tissue degeneration. It is known as a treatment with high unmet medical needs in the degenerative disc market, where there is no other treatment. In the United States, based on the clinical phase 2 data conducted by Yuhan Corporation, the local clinical phase 2 was exempted and the drug has entered clinical phase 3.
Spine Biopharma has conducted phase 3 clinical trials of SB-01 in 30 hospitals across the United States for the past two years, targeting 417 patients. This phase 3 clinical trial is being conducted for the purpose of confirming the treatment efficacy for chronic pain and pain-related functional loss due to degenerative disc disease. In particular, SB-01 is said to be the first candidate substance to enter phase 3 clinical trials as a treatment for degenerative disc disease in the United States.
Marc Viscogliosi, CEO of Spine Biopharma, said, “Degenerative disc disease is a field where there is no alternative to expensive surgery after years of conservative treatment, and the recovery period is long and the results are not easily predictable. By completing patient enrollment in the Phase 3 clinical trial of SB-01 ahead of schedule, we will do our best to ensure that patients suffering from chronic low back pain (CLBP) can benefit from new treatments.”
“We would like to thank the patients, site staff, clinical staff, and supplier partners who actively participated in this groundbreaking clinical trial,” said Fran Magee, PhD, Chief Technology Officer at Spine Biopharma. “We anticipate that SB-01 will be a clinically meaningful treatment option for patients with degenerative disc disease.”
According to Spine Biopharma, there are approximately 266 million patients suffering from degenerative disc disease worldwide. In the United States alone, approximately 22.5 million people have been diagnosed with the disease. Currently, there is no targeted treatment for degenerative disc disease. The symptoms are managed through physical therapy and other care, as well as prescriptions for nonsteroidal anti-inflammatory drugs (NSAIDS) and opioids.
Treatment of patients with chronic moderate-severe degenerative disc disease is evaluated to be performed with epidural steroid injections, nerve blocks, radiofrequency ablation, or surgical intervention, but it does not produce predictable treatment results. Chronic back pain caused by degenerative disc disease is also pointed out as a major cause, such as prescription of opioids (narcotic painkillers) that carry the risk of addiction and other side effects.
Meanwhile, Spine Biopharma directly signed a 215.4 billion won contract with Ensol Bioscience, a domestic company that first developed the candidate substance in July, to expand the indications of SB-01. In addition to degenerative disc disease, it is pursuing the expansion of the indications to musculoskeletal diseases, fibrosis, and tumors.
2024-09-25 09:24:13