Patara Pharma recently presented positive Phase 2 data on its lead candidate, PA101, for the treatment of refractory chronic cough in patients with idiopathic pulmonary fibrosis (IPF). The findings were given at the recent European Respiratory Society International Congress in London.
PA101 is a late-stage immune modulator with mast cell stabilizing properties that is delivered directly to the lungs via the company’s proprietary investigational PARI eFlow nebulizer system.
The randomized, placebo-controlled, double-blind, two-period crossover Phase 2 trial (NCT02412020) was conducted in 24 adult IPF patients with refractory chronic cough at multiple centers in the United Kingdom and the Netherlands. In the trial, patients with a daytime cough severity score of moderate to severe, and an average daytime cough count of at least 15 coughs per hour, were randomly assigned to inhaled PA101 or a placebo for a period of 14 days. After 14 days of washout, all patients switched to the opposite treatment.
Results showed that treatment with PA101 reduced by 30 percent the patients’ frequency of daytime cough compared to placebo on day 14. This significant reduction was supported by trends in all patient-reported subjective evaluations (cough-specific quality of life, cough severity, and the chest symptom domain of disease‑specific quality of life). There were no major adverse events related to the treatment and PA101 was reported to be well-tolerated.
“Chronic cough is a debilitating symptom for many IPF patients that can contribute to poor quality of life, psycho-social complications and potentially more rapid disease progression,” said Ahmet Tutuncu, MD, PhD, chief medical officer of Patara Pharma, in a press release. “We are encouraged by the significant improvement in chronic cough we observed among patients in our positive Phase 2 trial, and we plan to move forward in early 2017 with a robust Phase 2b study to identify the optimal dose.”
IPF is a progressive lung disorder for which there is no cure, characterized by the scarring and thickening of lung tissue, causing an irreversible loss of the lungs’ ability to transport oxygen. Chronic cough is a major contributor to poor quality of life in IPF patients, and can be an independent predictor of disease progression. Chronic cough is a dry, non-productive cough that persists for more than eight weeks, with cough being experienced up to 100 times per hour. While chronic cough is successfully treatable in many people, those with IPF can have a debilitating cough that persists despite treatment.