Aerovate Phase 2b trial of AV-101 fails primary endpoint; halts Phase 3 and extension

Jade Biosciences, Inc.

AV-101 did not meet primary endpoint of PVR improvement at any dose (10, 35, 70 mg BID); p-values all >0.36.
Secondary endpoint 6MWD also showed no meaningful improvement; LS mean differences ranging -11.7 to +1.3 meters.
Company halting enrollment and shutting down Phase 3 IMPAHCT and long-term extension study, per advisory committee.
Cash position ~$100M as of June 15, 2024; CEO calls results unexpected and disappointing.
Full Phase 2b data release timing to be determined; no new clinical path announced.

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