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Regenerative Medicine

Product Candidate

Thymosin Beta 4 in Dermal Healing

Thymosin beta-4 (Tβ4) is a naturally occurring peptide for which multiple mechanistic aspects have been described, including active site(s), receptor interactions, downstream signaling pathways, and associated biological activities. In preclinical evaluations, no dose-limiting toxicity was reported, and the available data indicate a favorable safety profile (1).

In phase 2 clinical trials in dermal injury, Tβ4 has shown signals of efficacy, with reductions in healing time approaching 50% in some studies (1). Dose-finding work has suggested a near-optimal topical concentration in the range of 0.02–0.03% (w/w) for dermal applications. Within the clinical studies reported to date, topical and injected Tβ4 have been generally well tolerated, with no study-related adverse reactions or autoantibody formation detected (1).

Tβ4 is a naturally occurring molecule that can be synthesized at scale, which may be relevant for eventual clinical use if further development confirms benefit and safety across larger and more diverse patient populations.

Reference

1. Kleinman HK, Sosne G. Thymosin β4 promotes dermal healing. Vitam Horm 2016;102:251-75. doi: 10.1016/bs.vh.2016.04.005.

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