A Revolutionary Plant-based Drug for Wound Healing; Seeks Guidance on Advancing Directly to Phase 2 Clinical Trials
Stramsen Biotech Inc. has successfully submitted a Pre-Investigational New Drug (Pre-IND) meeting request, accompanied by a comprehensive Pre-IND package, to the U.S. Food and Drug Administration (FDA) for its innovative wound care medicine, SBX1977. This meticulously crafted package, containing all essential pre-clinical data required for IND approval, marks a pivotal step towards our upcoming clinical trials and underscores our commitment to addressing critical healthcare needs.
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Stramsen is a venture backed plant-based biotechnology company with safe and advanced wound healing solutions and 32 other drug candidates for infectious and noninfectious diseases. This Pre-IND package outlines an ambitious clinical development strategy for SBX1977, a novel topical plant-based drug candidate engineered to treat both acute and chronic wounds, including the most challenging chronic diabetic wounds.
The FDA has acknowledged Stramsen’s submission and has granted Pre-IND meeting set for September 16, 2025.
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SBX1977 is a carefully formulated, standardized gel containing bioactive phytochemicals with powerful antimicrobial and wound-regenerative properties. This unique composition is rooted in time-honored tradition, with the plant material historically applied topically in a gel form to treat wounds and skin infections. Rigorous preclinical studies have not only confirmed the product’s potent antimicrobial activity but also demonstrated its remarkable ability to stimulate cell proliferation and tissue regeneration, all while maintaining an exemplary safety profile in animal models.
By leveraging the extensive historical human use and robust preclinical evidence, Stramsen aims to potentially bypass Phase 1 trials and advance directly to Phase 2. This innovative approach could dramatically expedite the development process, bringing this life-changing therapy to patients in need.
“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,” said Dr. Kefas Mugittu Ph.D, Co-CEO of Stramsen.
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Source- PR Newswire
