Direct Biologics expanded its ongoing Phase III trial beyond COVID-19-associated ARDS to include classic ARDS in 2023 following FDA approval.
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Clinical development rarely moves in a straight line; it moves as the data and the regulatory conversation evolve. In 2023, the FDA agreed to expand Direct Biologics' on…
Company
Direct Biologics
Direct Biologics develops investigational secretome-based products under cGMP standards, guided by scientific rigor.
- Industry
- Biotechnology Research
- Location
- Austin, US
- Company size
- 51–200 employees
About Direct Biologics
Our mission is to advance investigational therapies being studied to better understand their potential effects on immune and inflammatory pathways. Our vision is to advance research in cGMP-manufactured, secretome-based investigational products—including extracellular vesicles (EVs)—derived from adult bone marrow mesenchymal stem cells, advancing the future of regenerative medicine. Guided by our core values of Safety, Innovation, and Quality, Direct Biologics is developing investigational secretome-based products being studied in clinical research under cGMP manufacturing standards. We combine scientific approaches with a focus on quality to support the advancement of clinical research programs.
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Latest activity from Direct Biologics
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Operations & Supply
Direct Biologics moved into a new combined Quality Control and R&D laboratory facility in San Diego, California in 2024.
Legal & Regulatory
Direct Biologics completed the Phase II trial evaluating its investigational candidate in moderate-to-severe ARDS associated with COVID-19 in 2021.
Research & Knowledge
Direct Biologics currently has two active Phase II clinical trials ongoing in the IBD space, with study details NCT06918808 and NCT07625293.
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