Lung Therapeutics Announces Successful Completion of Phase 1a Clinical Trial of LTI-03 in Healthy Volunteers

AUSTIN, Texas--(BUSINESS WIRE)-- Lung Therapeutics, Inc., a clinical stage biopharmaceutical company focused on developing innovative treatments for the treatment of orphan pulmonary and fibrosis indications, announced the successful completion of a Phase 1a clinical trial for LTI-03, a Caveolin-1-related peptide designed to treat idiopathic pulmonary fibrosis (IPF).

The phase 1a clinical trial assessed ascending doses of LTI-03 in healthy normal volunteers. LTI-03 dose levels from 2.5 mg to 10 mg appeared to be safe and well tolerated with no reports of discontinuations or serious adverse events. In preclinical animal and ex-vivo models, LTI-03 was effective at doses equivalent to a human dose of between 1 and 10 mg. These preclinical studies demonstrated inhibition of pro-fibrotic signaling, as well as preservation of critical alveolar epithelial type 2 (AEC2) cells in the lungs.

Professor Fernando J. Martinez, M.D., Chief, Pulmonary and Critical Care Medicine at New York-Presbyterian Hospital/Weill Cornell Medical Center, said “IPF is a lethal lung disease for which novel and well-tolerated therapies are urgently needed. Lung Therapeutics LTI-03 uniquely inhibits both fibroblast activation and promotes the survival and function of alveolar epithelial cell subtypes needed for lung regeneration in IPF. The established safety of LTI-03 in normal volunteers clears the advancement of this inhaled therapeutic into IPF patients.”

“We are pleased that LTI-03 has passed this important safety milestone as we continue development,” said Brian Windsor, Ph.D., President and CEO 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.”

Caveolin-1 (Cav1)

LTI-03 is a seven amino acid peptide, the sequence of which is from the caveolin scaffolding domain, or CSD, an important binding region of the Cav1 protein. Cav1 normally serves a critical function in the prevention of fibrosis by maintaining a balance between pathways that both initiate and arrest lung repair and cell movement. Through the CSD, caveolin interacts with a large number of signaling molecules, all of which possess a caveolin binding sequence region. Cav1 conveys a homeostatic function in the process of fibrosis by (i) regulating the TGF- β1 receptor and its downstream signaling, (ii) regulating critical cellular processes involved in tissue repair, such as migration, adhesion and cellular response to mechanical stress; and (iii) antagonizing profibrotic processes, such as cellular proliferation. Cav1 expression is decreased in IPF lung tissues and has been demonstrated to decrease during the fibrotic phase of bleomycin, or BLM, lung injury in mice. Restoring the balance of important biological signals in the lung may not only slow lung function decline but could also restore healthy lung function through the protection of healthy epithelial cells.

About Lung Therapeutics, Inc.

Headquartered in Austin, Texas, Lung Therapeutics, Inc. is a clinical stage biopharmaceutical company formed to leverage leading research in orphan, pulmonary indications for which there are unmet medical needs. The company is developing a proprietary pipeline of novel therapeutics with the potential to greatly improve outcomes over currently available treatments. The company’s lead drug LTI-01 has received Orphan Drug Designation in the US and EU and Fast Track Designation in the US. LTI-01 is currently in a Phase 2, randomized, placebo-controlled, double-blind, dose-ranging study evaluating LTI-01 in patients with infected, non-draining loculated pleural effusions. The company’s second product candidate, LTI-03, is in development for idiopathic pulmonary fibrosis. For more information, visit Lung Therapeutics, Inc.

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