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Novel Bone Regeneration Drug Osteogrow: Therapeutic Solution for Lumbar Back Pain

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A new drug to regenerate damaged bone

Researchers have developed a novel treatment for chronic back pain to regenerate damaged bone in the spine.

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Chronic lumbar back pain is most commonly caused by degenerative spine disorders. In the EU, around 1.5 million people each year suffer from lumbar back pain that requires surgical intervention, representing a high economic and societal burden. This surgery comprises spinal fusion to immobilise one or more vertebral segments, which aims to correct instability and alleviate pain. Success rates are modest, at around 35 %, predominantly because bone is reabsorbed by the body around implanted rods and screws, causing further pain. In the EU-funded OSTEOproSPINE project, a team of researchers led by Slobodan Vukičević, head of the Laboratory for Mineralized Tissues at the University of Zagreb School of Medicine, developed a novel therapy, a bone implant, which induces new bone to form in damaged areas. Through initial clinical trials, the new treatment has been shown to stabilise the lumbar spine segment and prevent recurrence of back pain. Additionally, new clinical trials have been initiated to expand the use of this innovative solution to other difficult-to-treat diseases. In 2018, at the ‘Let the Stars Shine’ exhibition in the European Parliament in Brussels, the OSTEOGROW project was presented as one of the five most significant Croatian projects financed by the EU.

A new way to regenerate bone

The OSTEOproSPINE project has enabled a new bone regeneration therapy composed of Osteogrow (a drug that delivers critical bone proteins in a patient’s own blood carrier) reinforced with a compression-resistant matrix (CRM), allograft bone, to deliver a biomechanically competent implant that successfully regenerates bone. “Several global patents protecting the new bone drug formulations have been issued,” notes Vukičević.

Initial clinical trials

During the project, the new formulation was clinically tested in 143 patients in hospitals in Vienna, Linz and Graz. The treatment showed improvements over the current standard of care in several factors including physical functioning, physical role, pain, general health, vitality, social function, emotional role and mental health. The results were presented at the 13th International BMP Conference recently held in Dubrovnik. Following the success of these trials, the team tested several different CRMs. “We found that a combination of Osteogrow with synthetic ceramics showed outstanding results in animal models, leading to 100 % successful spinal fusion in sheep,” adds Vukičević. The procedure created significant bone volume, which was very dense throughout a follow-up period. This suggests it could preserve stability in human vertebrae for the duration of a lifetime. With these promising results, the OSTEOproSPINE project created a new formulation, Osteogrow-C, which is currently being tested in patients suffering from unhealed bone.

Bringing bone regeneration to the market

In these final Phase III clinical trials, the team is aiming for success in two metrics: spine fusion in patients with degenerative spine disorders, fracture nonunion (FNU) and alveolar ridge augmentation – testing the body’s ability to create bone where needed. The dental study is ongoing in 36 patients whereas the FNU study on 200 patients has been submitted for funding to the European Innovation Council (EIC). The team expects the Osteogrow-C formulation to reach patients in need in the EU by the end of 2028. “If successful in the final stage of the clinical testing, the product should ensure a long, eventually lifelong stability of the immobilised spine segment, which will significantly improve patients’ quality of life,” says Vukičević.

Keywords

OSTEOproSPINE, spine, lumbar, back pain, bone, regenerate, reinforced

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