Anti-Fibrotic Oral Treatment for IPF Showing Early Promise in Phase 2 Study

Anti-Fibrotic Oral Treatment for IPF Showing Early Promise in Phase 2 Study

Treatment with PBI-4050 may be a safe and effective therapy for patients with idiopathic pulmonary fibrosis (IPF), according to preliminary results from a Phase 2 clinical trial developed by ProMetic Life Sciences.

The study (NCT02538536) has enrolled 40 IPF patients at six different sites in Canada to investigate the safety, tolerability, and efficacy of PBI-4050 on lung function and IPF disease progression.

Preliminary results cover responses observed in the first 30 patients to have completed 12 weeks of treatment. Results found that PBI-4050 was safe and well-tolerated, and showed evidence of clinical effectiveness either alone or in combination with other IPF drugs, such as Ofev (nintedanib) and Esbriet (pirfenidone).

“We are very pleased with the results to date from this study as they provide us with very important data points relating to efficacy and safety,” said John Moran, chief medical officer of ProMetic, in a news release. “There is early evidence of efficacy in the patients treated with PBI-4050 alone and in those treated with PBI-4050 in combination with one of the commercially available drugs. This [evidence] compares favourably to that of the [Esbriet] or [Ofev] treatment reported in the ASCEND trial and in the two INPULSIS trials, respectively.”

The Phase 3 ASCEND (NCT01366209) and INPULSIS (INPULSIS-1, NCT01335464, and INPULSIS-2, NCT01335477) trials investigated the effectiveness of Esbriet and Ofev, respectively, in treating IPF patients. In these trials, after 13 weeks, IPF patients receiving treatment showed a lesser decline in forced vital capacity (FVC; a measure of lung function) than patients given placebo. In the PBI-4050 study, in comparison, IPF patients treated for 12 weeks with the investigational drug, alone or in combination with Ofev/Esbriet, showed a slight improvement in FVC.

“Further good news is the fact that PBI-4050 is very well tolerated by IPF patients whether used alone or in combination with either nintedanib or pirfenidone,” Moran added.

No patients under PBI-4050 treatment experienced a decline equal to or greater than 10 percent in their FVC during the 12 weeks of treatment, or death, the company reported. In contrast, a 10 percent FVC decline or worse, or death, was reported after the 13 weeks of treatment in 2.5 percent of ASCEND trial patients given Esbriet.

“As mentioned above, we use the information generated in these three large trials to help us benchmark PBI-4050’s performance whether used alone or in combination with the commercial agents,” said Joe Parker, senior director of Clinical Development at ProMetic. “IPF is a terrible condition where patients’ lung function keeps declining even when treated by pirfenidone or nintedanib. Our preliminary results are quite encouraging and will help us define the next steps for our promising lead drug candidate PBI-4050.”

PBI-4050 is an experimental oral drug designed to treat fibrosis, a process characterized by the replacement of normal tissue by fibrotic scar tissue, which affects the workings of several organs, including the lungs.

11 comments

    • Tim Bossie says:

      Hi Sri, right now this trial is going on in Canada with 40 participants. We are not sure of any type of expansion into other countries.

  1. Wendy Ford says:

    Obviously I want a trial to start in the UK.
    As soon as this is mentioned I would very much like to be considered please.
    I’m on intedanib Ofev but lower dose as can’t tolerate higher dose and struggled with Esbriet.
    I’m on live lung transplant list now and have had IPF for 5yrs when I was 52yrs.
    Thank you

  2. Tami says:

    I’m a recently diagnosed PF patient, age 64. I’ve just started Esbriet but would love to be part of this trial in the US. I’m a patient at a research facility now… UT SOUTHWEST MED SCHOOL.
    can anyone on this forum give me their experiences with Esbriet? I’ve just started it… taking 1 pill 3 x day.
    Thank you very much.

  3. jeff says:

    I have Idiopathic Pulmonary Fibrosis and have been on Pifenadone for 13 months . I now have productive cough and its getting more often I am in need of PBI4050 urgently is there any way to purchase in the UK Help Please 18/01/2017

  4. Ric says:

    A Phase 2 Study to Evaluate the Safety and Tolerability of PBI-4050 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
    This study is ongoing, but not recruiting participants.
    Sponsor:
    ProMetic BioSciences Inc.
    Information provided by (Responsible Party):
    ProMetic BioSciences Inc.
    ClinicalTrials.gov Identifier:
    NCT02538536
    First received: August 25, 2015
    Last updated: October 13, 2016
    Last verified: October 2016
    History of Changes
    Full Text View Tabular ViewNo Study Results PostedDisclaimerHow to Read a Study Record
    Purpose
    This is a Phase 2, open-label, single-arm study of the safety and tolerability of PBI-4050 800 mg daily oral administration in 40 adult patients with IPF.

    Condition Intervention Phase
    Idiopathic Pulmonary Fibrosis (IPF)
    Drug: PBI4050
    Phase 2

    Study Type: Interventional
    Study Design: Intervention Model: Single Group Assignment
    Masking: Open Label
    Primary Purpose: Treatment
    Official Title: A Phase 2, Open-label, Single Arm, Exploratory, Observational Study to Evaluate the Safety and Tolerability of PBI-4050 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

    Resource links provided by NLM:

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