Cohort 2 will evaluate high-dose LTI-03 (5 mg BID) Previously announced Cohort 1 data demonstrated positive trends in seven of the eight biomarkers evaluated, suggesting a potential therapeutic effect AUSTIN, Texas , Sept. 23, 2024 /PRNewswire/ -- Aileron Therapeutics, Inc. ("Aileron") (NASDAQ: ALRN ), a biopharmaceutical company advancing a novel pipeline of first-in-class medicines to address significant unmet medical needs in orphan pulmonary and fibrosis indications, today announced the completion of enrollment in Cohort 2 of the ongoing Phase 1b clinical trial of LTI-03 in IPF patients.
The last patient was enrolled in mid-September, with a total of 24 patients enrolled in the trial. Eligible patients are randomly assigned (3:1) to receive either inhaled LTI-03 or placebo. The primary objective of the trial is to evaluate the safety and tolerability of LTI-03 in patients with IPF after treatment for 14 consecutive days, with measurement of multiple protein biomarkers as exploratory endpoints.
"We are pleased to have completed enrollment in the high-dose cohort of our Phase 1b clinical trial and grateful to all participating patients and investigators," said Brian Windsor , Ph.D., President and Chief Executive Officer of Aileron.
"Following the positive trend observed in the low-dose cohort, we are excited to assess the safety, tolerability and biomarkers of 5 mg twice daily of inhaled LTI-03 and expect to report topline data in the near term." In May 2024 , the Company a.