Lung Therapeutics has concluded the Phase Ia clinical trial of its Caveolin-1-related peptide, LTI-03, intended for the treatment of idiopathic pulmonary fibrosis (IPF).

A seven amino acid peptide, LTI-03, addresses hindrance of pro-fibrotic signalling and key epithelial cell survival.

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The company noted that LTI-03 is a dry powder formulation intended for direct-to-lung administration.

The trial evaluated ascending doses of LTI-03 in healthy subjects. 

According to the findings from the trial, dose levels ranging from 2.5mg to 10mg of LTI-03 were demonstrated to be safe and well-tolerated.

Furthermore, no study discontinuations or serious adverse events were reported in this trial. 

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Lung Therapeutics president and CEO Brian Windsor said: “We are pleased that LTI-03 has passed this important safety milestone as we continue development. 

“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.”

The company noted that LTI-03 performed well at dose levels equivalent to a human dose ranging from 1 to 10mg in preclinical animal and ex-vivo models.

In addition, these preclinical data showed that the treatment with LTI-03 hindered pro-fibrotic signalling and preserved critical alveolar epithelial type 2 (AEC2) cells in the lungs.

Lung Therapeutics and Taiho Pharmaceutical signed an exclusive license agreement in November 2020 for a recombinant human single-chain urokinase plasminogen activator, LTI-01, in Japan.

In March 2017, the company commenced subject enrolment and dosing in a Phase Ia/b trial of LTI-01 to treat patients with loculated pleural effusions in Australia and New Zealand.