Spine BioPharma

Its lead candidate, SB‑01 (vicatertide), is a synthetic peptide designed to reduce inflammation and support tissue repair by modulating TGF‑β activity through a single intradiscal injection.

In March 2022, Spine raised US $13 million in Series B financing, led by investors including Pacira Biosciences, Viscogliosi Bros., and Cercano Management, to fund clinical advancement of SB‑01 . Enrollment of the Phase III MODEL trial (Moderate–Severe DDD Evaluation of the Lumbar Spine) completed in September 2024, with 417 patients enrolled across 30 U.S. centres .

In August 2025, topline results were announced: the trial did not meet its primary endpoint—a composite measure of pain reduction and functional improvement at six months—largely due to a higher-than-expected sham response . Despite this, 67% of SB‑01 recipients achieved clinically meaningful improvement at six months, and 62% maintained benefit at 12 months, with consistent safety and durability across patient subgroups .

SB‑01 remains Spine’s sole advanced candidate. With a focused pipeline, the company is evaluating regulatory pathways with the FDA and considering options to advance SB‑01 for low back pain in DDD, a major unmet need given limited non-surgical therapies.