Feb. 12 at 12:08 PM
$INMB INmune Bio Inc. (NASDAQ: INMB) announced it received FDA feedback confirming regulatory alignment on its proposed integrated Phase 2b/3 clinical development strategy for XPro1595 in early Alzheimer's disease.
The FDA indicated no objection to the company's integrated Phase 2b/3 design under a single master protocol. The Phase 2b portion will enroll approximately 300 participants over nine months, with the full program expected to enroll approximately 1,000 participants. The Phase 3 portion will evaluate XPro1595 over 18 months.
The FDA supported the company's biomarker-driven enrichment strategy, which will enroll patients defined by two or more biomarkers associated with peripheral inflammation and immune-mediated disease risk, including hsCRP, ESR, HbA1c, and APOE4.
