A phase 1a clinical trial testing the experimental idiopathic pulmonary fibrosis (IPF) treatment LTI-03 was successfully completed, according to a press release by Lung Therapeutics.
The randomized, double-blind, placebo-controlled, first-in-man, single and multiple ascending dose study assessed the safety, tolerability, and pharmacokinetics of LTI-03 in healthy volunteers. The study, sponsored by Lung Therapeutics, recruited 71 participants, aged 18 to 55 years, and was completed on December 23, 2021.
The primary outcome measure was the incidence of treatment-emergent adverse events measured by the Toxicity Grading Scale for Healthy Adult Volunteers.
The results showed that LTI-03 dose levels between 2.5 mg and 10 mg were safe and well-tolerated with no reports of discontinuations or serious adverse events recorded.
“We are pleased that LTI-03 has passed this important safety milestone as we continue development,” said Brian Windsor, PhD, president and chief executive officer of Lung Therapeutics. “We believe that the mechanism LTI-03 is unique among drugs in development for IPF, and we are excited to move LTI-03 into the next stage of clinical development in IPF patients later this year.”
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“The established safety of LTI-03 in normal volunteers clears the advancement of this inhaled therapeutic into IPF patients,” said Fernando J. Martinez, MD, the chief of Pulmonary and Critical Care Medicine at Weill Cornell Medical Center in New York.
LTI-03 is a caveolin-1 scaffolding protein-derived peptide designed to treat IPF. Caveolin normally prevents fibrosis by maintaining a balance between pathways that initiate and arrest lung repair and cell movement. In IPF, the expression of caveolin is reduced. Thus, restoring its balance in the lungs may slow lung function decline and could restore healthy lung function by protecting healthy epithelial cells.
Preclinical studies in animal models have shown that LTI-03 is able to inhibit profibrotic signaling while preserving critical alveolar epithelial type 2 cells in the lungs.
Lung Therapeutics announces successful completion of phase 1a clinical trial of LTI-03 in healthy volunteers. News release. Lung Therapeutics. March 22, 2022.
Safety, tolerability and pharmacokinetic study of LTI-03 in healthy adult subjects. US National Library of Medicine. March 7, 2022. Updated March 7, 2022.