FDA Status 

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Stramsen Biotech is pleased to announce the successful completion of a pre-Investigational New Drug (pre-IND) meeting with the Food and Drug Administration (FDA) panel on September 16th, regarding our wound care drug candidate SBX1977. This pivotal meeting has provided our research team with invaluable technical insights from FDA experts, guiding our preparations for clinical trials and reinforcing our commitment to advancing innovative therapeutic solutions.

 

SBX1977 demonstrates a compelling profile, supported by extensive historical human use and robust preclinical evidence. 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, while maintaining an exemplary safety profile in animal models. These findings suggest significant potential for addressing unmet needs in wound care management.

 

While our initial proposal sought to commence with a Phase 2 study, the FDA has advised that we first conduct a focused Phase 1 trial to strengthen the safety data package for SBX1977. This recommendation aligns with standard protocols in botanical drug development and will enable us to generate high-quality clinical safety data, potentially expediting and mitigating risks in subsequent larger efficacy trials. The Agency acknowledged the encouraging traditional and observational use of the plant derivative and provided detailed recommendations for designing a streamlined Phase 1 study, offering a clear path to an eventual Phase 2 program.

 

Typically, Phase 1 clinical trials involve small-scale studies encompassing 20-80 healthy participants to further evaluate safety parameters, including potential adverse events and optimal dosage determination. This crucial step in the drug development process will provide valuable insights into the pharmacokinetics and pharmacodynamics of SBX1977, further elucidating its potential as a novel therapeutic agent.

 

Stramsen Biotech extends its sincere gratitude to the FDA panel for their time and engagement in this virtual meeting with our scientific team. The discussion proved highly informative and constructive regarding the SBX1977 wound healing drug candidate. Both Stramsen and FDA teams anticipate a subsequent pre-IND meeting in the coming weeks, following our comprehensive implementation of the FDA's recommendations. This iterative process exemplifies the collaborative nature of drug development and regulatory compliance.

 

We remain steadfast in our commitment to advancing our research in compliance with regulatory standards and look forward to further collaboration with the FDA. Our goal is to bring potentially groundbreaking treatments to healthcare providers and patients.

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