Patara’s Trial Data Supports PA101 as Chronic Cough Treatment in IPF

Patara’s Trial Data Supports PA101 as Chronic Cough Treatment in IPF

Clinical trial results of Patara Pharma’s inhaled therapy candidate PA101 for chronic cough caused by idiopathic pulmonary fibrosis (IPF) indicate the medication reduces cough in a disease-specific manner.

The findings, published in the journal The Lancet Respiratory Medicine, were derived from a Phase 2 trial (NCT02412020) of PA101. While IPF patients saw a reduction in cough and improved quality of life using the treatment, participants with chronic idiopathic cough did not experience any benefits.

Patara is now moving toward a Phase 2b study of the therapy, in which researchers will find the optimal dosing of PA101.

“The publication of our Phase 2 results … is an important milestone in our program to treat persistent cough in IPF patients, an often debilitating and difficult-to-treat symptom of IPF,” Bill Gerhart, CEO of Patara Pharma, said in a press release.

Titled “A novel formulation of inhaled sodium cromoglicate (PA101) in idiopathic pulmonary fibrosis and chronic cough: a randomized, double-blind, proof-of-concept, phase 2 trial,” the report described how 24 IPF patients were randomly assigned treatment either with PA101 or a placebo. Twenty-seven patients with idiopathic chronic cough also were included.

Results, which had been presented at an earlier scientific meeting, showed that after 14 days of treatment, IPF patients coughed significantly less — 31.1 percent during the day and 29.1 percent over 24 hours. This translated to a reduction from 55 to 39 coughs per patient during the day after two weeks of treatment.

Researchers considered a reduction of 30 percent clinically significant. Looking only at patients who responded to the treatment according to this cut-off, PA101 reduced daytime cough by 59 percent.

Patients also reported improved cough-related quality of life, but the improvement was not statistically significant. This was likely related to the small size of the study, researchers said.

Importantly, the drug was very well-tolerated, with no significant adverse events reported during the trial.

PA101 is an inhaled version of sodium cromoglicate, a drug that has been used in asthma patients for decades. In an accompanying commentary in the The Lancet Respiratory Medicine, Stuart B. Mazzone, MD, from the University of Melbourne in Australia, supported the notion that the drug likely acts in a more complex manner than previously thought.

It likely has anti-inflammatory actions on several cell types and might impact nerve impulses related to cough, he wrote. Mazzone also applauded the study for taking on an aspect of IPF that has received too little attention.

7 comments

  1. Eric Strayer says:

    What the heck does this statement mean? Does the stuff work on chronic cough or not? These two paragraphs contradict each other.

    Patara’s Trial Data Supports PA101 as Chronic Cough Treatment in IPF
    by Magdalena Kegel

    – Clinical trial results of Patara Pharma’s inhaled therapy candidate PA101 for chronic cough caused by idiopathic pulmonary fibrosis (IPF) indicate the medication reduces cough in a disease-specific manner. –

    – The findings, published in the journal The Lancet Respiratory Medicine, were derived from a Phase 2 trial (NCT02412020) of PA101. While IPF patients saw a reduction in cough and improved quality of life using the treatment, participants with chronic idiopathic cough did not experience any benefits.” –

    • Magdalena Kegel says:

      Hi Eric,

      The trial included patients with chronic cough caused by IPF or due to unknown reasons (idiopathic cough). While the medication improved cough in IPF patients, it did not improve cough in patients without IPF. That suggests that cough in people with IPF is caused by other factors than cough in other patients.

  2. Peter Davies says:

    I am so pleased that things are moving forward in the ipf (cough stage )as it is really affecting standard of life that people just dont understand , have just found your pages and it is a great comgort to know others out there that understand how i feel . I am a golfer who struggles badly on hills so am looking forward to finding something that helps many thanks for your pages yours in health, pete davies

    • Magdalena Kegel says:

      Hi,
      The treatment is only heading for a Phase 2b trial, so it will likely take a couple of years before it will become available. For patients, there is also the possibility to participate in a clinical trial. Right now there is, however, no information on when the next trial may begin.

    • Magdalena Kegel says:

      You can search for clinical trials in your area directly at https://clinicaltrials.gov/. Trials recruiting participants offer contact details to study staff and eligibility information on their registration page.We also frequently share information about clinical trials. Please sign up for our newsletter if you wish to receive such info.

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