FDA agrees MCH/H findings not dose-limiting for Rein Therapeutics' LTI-03 Phase 2 trial; CRL submission planned

Rein Therapeutics, Inc.

FDA confirmed MCH/H findings in GLP rat studies are not dose-limiting for proposed 24-week LTI-03 protocol at doses up to 10 mg/day in IPF patients.
FDA stated Complete Response Letter (CRL) need not include new GLP rat toxicity study; Rein will prepare CRL in coming weeks.
FDA recommended CRL include updated clinical safety, PK/PD data, augmented safety monitoring with spirometry, and DSMB unblinded reviews.
Clinical hold on U.S. Phase 2 RENEW trial (LTI-03) remains; company hopeful for timely release after CRL submission.

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