Brain Biotech names J Johan Jansen-Storbacka as EVP of

Brain Biotech names J Johan Jansen-Storbacka as EVP of

Stramsen Biotech Inc. has made significant progress in its quest to revolutionize wound care with its innovative SBX1977 medicine. On August 28, 2025, the company submitted a Pre-Investigational New Drug (Pre-IND) package to the U.S. Food and Drug Administration (FDA) for SBX1977, a topical plant-based drug candidate designed to treat both acute and chronic wounds, including challenging chronic diabetic wounds [1].

The Pre-IND package, which includes all essential pre-clinical data required for IND approval, marks a pivotal step towards clinical trials. Stramsen Biotech has requested a Pre-IND meeting set for September 16, 2025, during which the company aims to discuss its strategy for advancing SBX1977 directly to Phase 2 clinical trials. This innovative approach could potentially bypass Phase 1 trials, expediting the development process and bringing this life-changing therapy to patients in need [1].

SBX1977 is a carefully formulated gel containing bioactive phytochemicals with powerful antimicrobial and wound-regenerative properties. Rigorous preclinical studies have confirmed the product's potent antimicrobial activity and its ability to stimulate cell proliferation and tissue regeneration. The historical human use of the plant material in a gel form further supports the safety and efficacy of SBX1977 [1].

Dr. Kefas Mugittu, Co-CEO of Stramsen Biotech, expressed confidence in the potential for waiving a separate Phase 1 trial. "The wealth of existing safety and efficacy evidence for SBX1977 presents a compelling case for potentially waiving a separate Phase 1 trial. FDA concurrence with our assessment would enable us to advance directly to Phase 2," he said [1].

Stramsen Biotech is a venture-backed plant-based biotechnology company with a portfolio of 33 drug candidates for infectious and noninfectious diseases. The company's commitment to addressing critical healthcare needs is evident in its ambitious clinical development strategy for SBX1977 [1].

While forward-looking statements regarding regulatory interactions, clinical development plans, and the anticipated benefits of SBX1977 are promising, it is important to note that actual results may differ due to various risks and uncertainties inherent in the drug development process [1].

References:
[1] https://www.morningstar.com/news/pr-newswire/20250828ph61155/stramsen-biotech-submits-pre-ind-package-to-fda-for-sbx-1977-wound-care-medicine-requests-pre-ind-meeting-and-phase-2-trial