SAN DIEGO, Sept. 21, 2017 /PRNewswire/ -- Patara Pharma, a clinical-stage biopharmaceutical company developing therapeutics that significantly improve the lives of patients with chronic inflammatory lung diseases and immune disorders, today announced that the positive results from its phase 2 clinical trial of lead drug candidate PA101 have been published in The Lancet Respiratory Medicine. The study, "A novel formulation of inhaled sodium cromoglycate (PA101) in idiopathic pulmonary fibrosis and chronic cough: a randomized, double-blind, proof of concept, phase 2 trial," appears in the September 2017 issue.
In the 24-patient Phase 2 trial, PA101 demonstrated a statistically significant reduction in daytime and 24-hour cough frequency among idiopathic pulmonary fibrosis (IPF) patients versus placebo following 14 days of treatment. The reduction was supported by positive trends in cough-specific quality of life and cough severity, as assessed by patients in the study. The therapy was well tolerated, with no significant treatment-related adverse events.
The study also evaluated a second cohort of patients with chronic idiopathic cough, a condition unrelated to IPF. While PA101 was well tolerated in this group, the drug did not provide a treatment benefit, suggesting that PA101's benefits are disease specific.
"The publication of our Phase 2 results in The Lancet Respiratory Medicine is an important milestone in our program to treat persistent cough in IPF patients, an often debilitating and difficult-to-treat symptom of IPF," said Bill Gerhart, CEO of Patara Pharma. "An independent commentary accompanying the article described the findings as an important advancement in the treatment of this significant unmet medical need."
Patara now plans to move forward with a robust Phase 2b study to identify the optimal dose for PA101.
IPF is a chronic and progressive lung disease of unknown cause, with a mean survival rate of 3-5 years post diagnosis. Most patients with IPF suffer from a dry, non-productive cough that is disruptive to daily activities; it's associated with pain, morbidities and psycho-social complications. Although the exact mechanism of cough in IPF patients is unknown and heterogenic, release of mast cell mediators and other inflammatory processes have been implicated.
Patara's lead candidate, PA101, is a novel inhaled formulation of cromolyn sodium, a mast cell stabilizer with pleotropic immune modulating properties. PA101 is delivered via a proprietary closed-system version of the eFlow electronic nebulizer device that achieves high, therapeutically relevant lung doses of cromolyn safely and conveniently.
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. A robust phase 2b clinical trial is planned for the treatment of IPF patients with persistent cough. Patara maintains its corporate headquarters in San Diego. For more information about Patara Pharma, please visit www.patarapharma.com.
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SOURCE Patara Pharma