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Charlotte's Web minority-interest DeFloria gets FDA clearance for Phase 2 autism trial
Charlotte's Web Holdings, Inc.
- FDA cleared DeFloria's IND to proceed with Phase 2 trial of AJA001 Oral Solution for autism spectrum disorder symptoms.
- AJA001 uses Charlotte's Web proprietary full-spectrum CBD hemp extract from patented cultivars.
- Phase 2 will assess safety/tolerability/efficacy in adolescents and adults with ASD.
- DeFloria is a collaboration between Charlotte's Web (minority stake) and Ajna BioSciences PBC.
- CEO cites milestone in moving hemp genetics from consumer wellness to regulated medical sector.