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Clinical Trials Timeline

 

Stramsen Biotech is preparing for a planned combined Phase 1/2 clinical trial of SBX-1977, its investigational plant-based wound-healing gel. The trial is expected to begin in January 2027 and will combine Phase 1 safety and tolerability assessments with Phase 2 evaluation of preliminary efficacy. Initiation remains subject to financing, completion of required development and manufacturing activities, and applicable regulatory and ethics approvals.

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The company plans to submit a comprehensive Investigational New Drug (IND) application for SBX-1977 to the U.S. Food and Drug Administration (FDA) in the coming weeks. In parallel, Stramsen Biotech is evaluating opportunities to initiate clinical trials in select jurisdictions outside North America, including pathways that may support an earlier start while meeting applicable local requirements and relevant FDA standards for potential use of the resulting data in future U.S. submissions.

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Discussions with potential contract research organization (CRO) partners are ongoing. The company will share further details regarding trial locations, timelines, and development plans as these discussions progress and arrangements are finalized.

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Following successful completion of the Phase 2 portion of the SBX-1977 trial, Stramsen Biotech intends to advance additional candidates into clinical development, subject to funding, completion of required supporting studies, and applicable approvals. These candidates include SBX-1968 for prostate cancer, SBX-2021 for multiple solid tumors, SBX-2022 for hematological cancers, and SBX-2000 for cardiovascular diseases.

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