In a 24-patient Phase 2 study, PA101 demonstrated a statistically significant reduction in daytime cough frequency versus placebo on Day 14 compared to baseline. This reduction in cough frequency was supported by positive trends in cough-specific quality of life and cough severity as assessed by patients in the study. Importantly, the therapy was well tolerated, with no significant treatment-related adverse events.
"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," stated Ahmet Tutuncu, M.D., Ph.D., chief medical officer of Patara Pharma. "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."
Study Design and Results
Patara conducted the randomized, double-blind, placebo-controlled, two-period crossover study at multiple centers in the United Kingdom and the Netherlands, evaluating 24 adult IPF patients with refractory chronic cough. Patients with a daytime cough severity score of moderate/severe and an average daytime cough count of at least 15 coughs per hour using an objective cough monitor at screening were randomized in the study to receive either inhaled PA101 or matching placebo for 14 days, then switched to the opposite treatment after 14 days of washout. Objective 24-hour cough frequency was obtained at baseline and Day 14 using the Leicester Cough Monitor, as well as subjective patient reported assessments of cough severity, cough-specific quality of life, and disease-specific quality of life.
There was a statistically significant 30 percent reduction from baseline in average daytime cough frequency at Day 14 during treatment on PA101 vs treatment on placebo (ratio of LS Means and 95 percent CI = 0.67 [0.48, 0.94], p=0.024). This reduction in cough frequency was supported by meaningful trends in all of the patient-reported subjective assessments (cough-specific quality of life, cough severity, and the chest symptom domain of disease‑specific quality of life) favoring treatment with PA101, suggesting a positive relationship between objective cough count and subjective outcome measures.
Improvements in all patient reported outcome scores were more significant for those patients on PA101 who achieved >30 percent reduction in average 24-hour cough count than for the total number of IPF patients on PA101, demonstrating a strong correlation between the magnitude reduction in cough experienced by IPF patients and improvements in their quality of life and cough severity scores.
Overall, treatment with PA101 administered for 14 days was safe and well tolerated in the patients who participated in this study. There were no serious adverse events. The incidence of treatment-emergent adverse events was comparable between the two treatments, and most of those were mild in severity and did not require treatment.
About Patara Pharma
Patara Pharma is a clinical-stage biopharmaceutical company developing new therapeutics that significantly improve the lives of patients with chronic inflammatory lung diseases and immune disorders. The company's lead candidate, PA101, is an inhaled formulation of an anti-inflammatory therapeutic delivered via a proprietary electronic nebulizer device. PA101 is currently being evaluated in Phase 2 clinical trials in multiple indications, with a focus on the treatment of refractory chronic cough in patients with idiopathic pulmonary fibrosis. Patara maintains its corporate headquarters in San Diego. For more information about Patara Pharma, please visit www.patarapharma.com.
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/patara-pharma-announces-positive-phase-2-results-for-the-treatment-of-refractory-chronic-cough-in-patients-with-idiopathic-pulmonary-fibrosis-300323526.html
SOURCE Patara Pharma