12 November 2020 - - Japan-based Taiho Pharmaceutical Co., Ltd, and US-based Lung Therapeutics, Inc. have entered an exclusive license agreement of LTI-01, a recombinant human single-chain urokinase plasminogen activator, currently under development by Lung Tx for loculated pleural effusions, for the territory of Japan, the companies said.

Under the terms of the agreement, Taiho will obtain the rights for the development and commercialization of LTI-01 in Japan.

Lung Tx will receive an upfront payment, milestone, and royalty payments based on product sales.

Loculated pleural effusion is a condition in which fluid is trapped within the pleural cavity due to fibrinous adhesions, leading to pain, shortness of breath and possibly sepsis.

There currently are no approved drug treatment options for this condition.

LTI-01 is anticipated to promote drainage in LPE patients by lysis of fibrinous scar tissue in the pleural cavity.

LTI-01 is an injectable proenzyme, or zymogen, that enhances the fibrinolytic system and breaks down the fibrinous scar tissue which causes LPE. A Phase 2, randomized, placebo-controlled, double-blind, dose-ranging study in patients with infected, non-draining LPE is being conducted in the US1. 

LTI-01 has received Orphan Drug Designation in the US and EU and Fast Track Designation in the US.

Pleural Effusion is an accumulation of excessive fluid in the pleural cavity. Patients are typically treated by chest drainage to alleviate its symptoms such as dyspnea or chest pain.

Loculated Pleural Effusion is a condition often associated with empyema or complicated parapneumonic pleural effusions, where the loculation of fluid occurs due to fibrinous adhesions and, therefore, becomes difficult to drain.

Currently, the only approved treatments for an LPE are interventions such as chest tube drainage, and if unsuccessful, a surgical procedure.

LPE is closely associated with pleural infection, and there are an estimated 80,000 new cases of pleural infection in the UK and US each year.

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.

Taiho Pharmaceutical, a subsidiary of Otsuka Holdings Co., Ltd., is an R and D-driven specialty pharma company with a focus on oncology.

Taiho Pharmaceutical also has development programs in allergy and immunology, urology, and consumer healthcare products.