Peniel2000, P2K

P2K : Degenerative Disc Disease Drug

"Degenerative Disc Disease (DDD) is one of the main causes of chronic lower back pain, which restricts social activities and lowers the quality of life for those suffering from back pain. With the rapid increase in the aging population due to advancements in medical and healthcare technologies, degenerative diseases have become an important issue not only for improving the quality of life in the elderly but also for reducing societal costs.

Among these, Degenerative Disc Disease is one of the representative degenerative diseases affecting many elderly individuals, caused by the degeneration of the intervertebral disc (IVD), which serves as a shock absorber and provides flexibility to the spine. The disc is mainly composed of the nucleus pulposus (NP), which contains proteoglycans (PG), and the annulus fibrosus (AF), which surrounds the nucleus and is primarily composed of collagen. Biochemical changes associated with aging or physical stress can lead to the degeneration of this disc tissue, resulting in disease.

Currently, treatments for Degenerative Disc Disease are varied, ranging from conservative therapies aimed at relieving symptoms, such as drug therapy, injection therapy, and physical therapy, to simple surgical interventions and even surgical procedures like artificial disc replacement. However, there is no fundamental treatment available to restore a disc that has already undergone degeneration. Recently, regenerative therapies using growth hormones or stem cells are being researched, but they are still in the preclinical or clinical trial stages. Due to the avascular nature of the disc tissue, which limits its ability to regenerate or repair once degeneration has progressed, finding a fundamental treatment for degenerative diseases like Degenerative Disc Disease requires the development of more convenient and clinically applicable regenerative therapies. Therefore, we aimed to develop an in vivo therapeutic substance that can reverse the degeneration of disc tissue once it has begun.

Peniel2000 (P2K) is a synthetic peptide that inhibits disc degeneration, induces disc regeneration, and alleviates pain, one of the primary symptoms of Degenerative Disc Disease. These effects of Peniel2000 are due to its regulation of the TGF-β1 signaling pathway, a protein that promotes disc degeneration. Peniel2000 binds to TGF-β1, blocking the Smad1/5/8 pathway, which promotes disc degeneration, while activating the Smad2/3 pathway, which induces disc regeneration. Additionally, it reduces the expression of the pain-inducing factor NGF (Nerve Growth Factor), thus exhibiting pain-relieving effects."

Peniel2000 has been licensed to a U.S. company and is currently undergoing a FDA Phase 3 clinical trial. It is expected to become the world’s first treatment for Degenerative Disc Disease. Additionally, development is being pursued to expand its indications to musculoskeletal and non-musculoskeletal fibrotic diseases, as well as tumor-related indication