FDA Status
 

Stramsen Biotech received encouraging written feedback from the U.S. FDA following its Pre-IND submission for SBX-1977, our lead topical botanical drug candidate for wound healing.

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Importantly, the FDA indicated that the CMC and nonclinical packages appear reasonable to support IND submission and initiation of the proposed Phase 1 trial.

 

The FDA also provided guidance across CMC, nonclinical, and clinical areas, including recommendations on the proposed Phase 1 study design, study population, endpoints, and safety assessments.
 

Stramsen Biotech is incorporating this feedback as it prepares a comprehensive IND submission for FDA review prior to initiating first-in-human studies.

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SBX-1977 is a topical botanical gel being developed to promote wound healing and closure. Preclinical studies have demonstrated effects on fibroblast proliferation and migration, wound closure, tissue remodeling, and antimicrobial activity.
 

Forward-Looking Statements

This announcement contains forward-looking statements regarding the development of SBX-1977, including plans for IND submission and the initiation of clinical trials. These statements are subject to risks and uncertainties, including regulatory review outcomes and the ability to meet anticipated development timelines. Actual outcomes may differ materially from those anticipated.