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Positive Phase II in eosinophilic asthma for Pulmagen/Teijin

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Pulmagen Therapeutics (Asthma) Limited, a UK based drug development company, announces today positive data for PTR-36 (ADC3680), a
once daily, orally administered CRTh2 antagonist in eosinophilic asthma patients in a 16-week Phase II double blind, placebo controlled study, that was conducted in Japan by
Tokyo-based Teijin Pharma Limited, the core company of the Teijin Group’s healthcare business. Pulmagen licensed its CRTh2 programme including PTR-36 for Japan to Teijin
Pharma in 2012. Pulmagen is to seek a global partner for late stage clinical development.

The aim of this study was to collect efficacy and safety data for PTR-36, an oral chemoattractant receptor-homologous molecule expressed on Th2 cells (CRTh2) receptor
antagonist, for the treatment of asthma.

This was an exploratory Phase II, double-blind, randomized, placebo-controlled multi-center study with inhaled corticosteroid (ICS) dose tapering and cessation. Patients with mild to
moderate asthma (N = 158) had their long-acting β-agonists (LABA) discontinued and were standardised on a medium dose of ICS for 28 days prior to randomisation. At the start of the
16-week treatment period the dose of ICS was reduced to a low dose and patients were randomized (1:1:1) to two doses of PTR-36 (5 mg or 20 mg once daily) or to placebo for an
initial 28 days after which the ICS was fully discontinued. Patients then remained on PTR-36 or placebo for a further 12 weeks. (Clinical trial registration number: JapicCTI-152857)

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