Stramsen Biotech Thanks the FDA for Their Review and Positive Feedback on Pre IND Application for SBX-1977 Wound Care Medicine
The company is seeking law firms and investment banks for potential capital market partnerships; two Experienced Co-CFOs have joined Stramsen.
HOUSTON, June 2, 2026 /PRNewswire/ -- Stramsen Biotech, announced today that it has received written feedback from the U.S. Food and Drug Administration (FDA) regarding its Pre-Investigational New Drug (Pre-IND) submission for SBX-1977, the Company's lead botanical drug candidate for wound healing indication.
The FDA's written responses received on April 21, 2026, indicated that the Company's proposed chemistry, manufacturing and controls (CMC) strategy and nonclinical package appear reasonable to support IND submission and the planned Phase 1 study. The Agency also provided recommendations to further improve the clinical trial design, safety monitoring, pharmacokinetic assessments, product quality controls, and future development requirements to support later-stage clinical trials and eventual marketing approval.
SBX-1977 is a novel botanical drug candidate being developed as a potential wound-healing therapy. The product is designed to address significant unmet medical needs by enhancing the body's natural tissue repair mechanisms and accelerating wound closure.
"We appreciate the FDA's thorough review of our Pre-IND submission and the constructive feedback provided. The Agency's comments provide valuable clarity as we finalize our development strategy and prepare for IND submission," said Dr. Kefas Mugittu, Ph.D., Co-CEO and Technical Lead of Stramsen.
The Company is currently incorporating the FDA's recommendations into its development plans and expects to submit its IND application in the coming weeks, subject to completion of ongoing regulatory, manufacturing, and supporting development activities.
Upon IND clearance, Stramsen Biotech intends to initiate a Phase 1 clinical study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary wound-healing activity of SBX-1977 in adults undergoing dermatologic surgical excision procedures.
Professor Hamisi Malebo, Ph.D., Stramsen Biotech's Chief Chemist, stated: "Our strategy is to advance drug candidates through FDA approval to deliver innovative therapies to patients. Beyond SBX-1977, our portfolio includes 32 plant-based therapeutic assets in various R&D stages.
Strengthening Leadership for Corporate Growth
Stramsen Biotech has restructured its executive leadership. The company moved from a traditional Director of Finance/CFO model to a Co-CFO structure, adding talent with global finance and capital markets expertise. This ensures its financial strategy is managed by a team capable of navigating the biotech investment landscape.
Stramsen Biotech is proud to introduce Ms. Kimberly Graper, CPA, JD, and Mr. John Griffin, MBA, MS, as its new Co-CFOs. Together, they represent the most experienced and formidable financial leadership duo in the history of Stramsen Biotech. Detailed professional biographies for the new executive leaders can be found at the links at the bottom of this article.
Stramsen aims to capture 1–5% of the combined $1.7 trillion herbal medicine and general therapeutics market within 10–20 years. This could generate annual gross revenues of $17–85 billion in 10–20 years.
Forward-Looking Statements
This press release contains forward-looking statements for SBX-1977, including IND submission, clinical development, financing, and future operations. Actual results may differ due to regulatory, clinical, financial, and other risks in biotech development.
Contact information:
Scott Villwock
President & CEO
713.955.1156
[email protected]
www.stramsenbiotech.com
Stramsen Biotech, Inc: Overview | LinkedIn
SOURCE Stramsen Biotech Inc
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