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Idiopathic Pulmonary Fibrosis

Jeremy Feldman, MD

  • What is Idiopathic Pulmonary Fibrosis?
    • Idiopathic Pulmonary Fibrosis Definition
    • Symptoms of Idiopathic Pulmonary Fibrosis
    • Causes of Idiopathic Pulmonary Fibrosis
    • Who Gets Idiopathic Pulmonary Fibrosis
    • Gastro-Esophageal Reflux (GER) and Idiopathic Pulmonary Fibrosis
    • Interstitial Lung Disease vs. Idiopathic Pulmonary Fibrosis
    • Is Pulmonary Fibrosis Hereditary?
    • Research, Life Expectancy and Prognosis for Idiopathic Pulmonary Fibrosis
  • Diagnosing & Monitoring PF
    • Monitoring Progress of IPF
    • Idiopathic Pulmonary Fibrosis Diagnosis
    • Chest X-rays Used in IPF
    • CPET used in IPF
    • HRCT Scans Used to Evaluate IPF
    • Lung Biopsy To Diagnose IPF
    • Pulmonary Function Tests (PFTS)
    • Six Minute Walk Test To Monitor IPF
    • Stages of Idiopathic Pulmonary Fibrosis
    • Complications of Idiopathic Pulmonary Fibrosis
  • PF Treatment Options
    • Esbriet (pirfenidone) Used to Treat IPF
    • OFEV (nintedanib) Used to Treat IPF
    • Pulmonary Rehab for IPF Patients
    • Lung Transplantation for Pulmonary Fibrosis
    • Oxygen Used to Treat IPF
      • Update on Oxygen Use
    • Clinical Trials in Idiopathic Pulmonary Fibrosis
    • IPF & Leg Swelling
    • Pulmonary Hypertension and Idiopathic Pulmonary Fibrosis
    • IPF Exacerbation
  • PF Advocacy & News
  • FAQ’s
    • Respiratory failure, NSIP, diet
    • Leg swelling, lung biopsy, side effects & pets
    • FAQ’s Enzyme Therapy, Progression of IPF & Oxygen
    • FAQ: Diarrhea, Fibrosis Reversal, IPF Symptoms
    • FAQ: Oxygen Flow, Anesthesia & Genetics
    • FAQ: Contagious Cough? Stem Cells, Familial IPF, Flying
    • FAQ: GERD, Fatigue & Environmental Exposure
    • FAQ: How to Travel to Your Doctor’s Office with Oxygen
    • FAQ: Lung Biopsy with Pulmonary Fibrosis
    • FAQ’s: Alcohol, Clinical Trials, Pulmonary Function Testing
    • FAQs: Emphysema, Exercise & Lung Biopsy

Pamrevlumab Ineffective in Treating IPF

December 3, 2023 By Dr. Jeremy Feldman

In June of 2023 Fibrogen announced the results of the ZEPHYRUS-1 clinical trial of Pamrevlumab in IPF.  Pamrevlumab entered phase 3 with much anticipation.  Phase 2 work suggested that the molecule had a high chance of success.  Unfortunately, in the phase 3 study which included 356 subjects, Pamrevlumab was not effective at preserving lung function.  As a result, Fibrogen ended the development of this drug for IPF.  

Why do medications look promising in phase 2 studies fail in phase 3?  Phase 2 studies are smaller studies, conducted in fewer sites, usually with various doses of the study medication compared to placebo.  The phase 2 Pamrevlumab study included about 100 subjects with IPF and none were treated with currently approved IPF medications (pirfenidone or nindatenib).  The study was 48 weeks in duration and the primary endpoint was decline in lung function.  In the phase 2 study, Pamrevlumab reduced the rate of decline in lung function by 60%.  Of note, the study took 4 years to complete.   There was no way to have predicted based on the phase 2 data that the Pamrevlumab would prove ineffective in IPF.  There is always risk of failure in clinical trials.  

The typical journey for a molecule to become an effective therapy is long and arduous.  The first stage of the journey usually is a decade or more of basic laboratory science that identifies a molecular pathway that seems to be associated with a disease.  Next a molecule that seems to impact the abnormal pathway is studied in animal models of the disease.  Next, the molecule is studied in healthy people in single and multiple dose exposures (this is called phase 1).  At this time, the company decides if there is enough basic science and animal model data paired with safety data from phase 1 to move forward into phase 2.  Phase 2 usually looks at several different doses compared to placebo.  If the phase 2 results look promising, then the molecule moves into phase 3. This phase usually involves many study sites around the world and enrolls many more subjects than in phase 2.  Statisticians are involved in the design of the study protocols helping to determine how best to evaluate the data and how large the study needs to be in order to have a high probability of answering the key efficacy question.  The sponsoring company works closely with the Food and Drug Administration (FDA) to develop phase 2 and 3 protocols.  

The risk of failure is high for any given molecule.  Drugs can be divided into “Me Too” medications (newer versions of already approved therapies) and novel molecules with novel mechanisms of action.  The former group has a higher chance of success but rarely leads to major breakthroughs.  In contrast, the latter group has a higher failure rate but can lead to dramatic advances. 

We must always remember that without clinical trials we would have no progress in medicine.  The patients who volunteer to participate in phase 2 and 3 trials are the real heroes.  They give their time and energy and take on some risk in the quest of new, more effective treatments.  Hats off to the many patients who continue to push medicine forward and participate in clinical trials.  Although we have a tendency to mourn the negative studies and “misses”.  Even in negative trials we advance our understanding of disease and increase the likelihood of eventual success with the next round of clinical trials.  

Filed Under: IPF Treatment, Research, Uncategorized Tagged With: IPF

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What is IPF?

  • What is Idiopathic Pulmonary Fibrosis?
    • Symptoms of Idiopathic Pulmonary Fibrosis
    • Causes of Idiopathic Pulmonary Fibrosis
    • Who Gets Idiopathic Pulmonary Fibrosis
    • Gastro-Esophageal Reflux (GER) and IPF
    • Interstitial Lung Disease vs. Idiopathic Pulmonary Fibrosis
    • Is Pulmonary Fibrosis Hereditary?
    • Research, Life Expectancy & Prognosis for Pulmonary Fibrosis

Diagnosing IPF

  • Idiopathic Pulmonary Fibrosis Diagnosis
    • Chest X-rays Used in IPF
    • CPET used in IPF
    • HRCT Scans Used to Evaluate IPF
    • Lung Biopsy To Diagnose IPF
    • Pulmonary Function Tests (PFTS)
    • Six Minute Walk Test To Monitor IPF
    • Stages of Idiopathic Pulmonary Fibrosis
    • Complications of Idiopathic Pulmonary Fibrosis

Treating IPF

  • Pulmonary Fibrosis Treatment Options
    • Esbriet (pirfenidone) Used to Treat IPF
    • OFEV (nintedanib) Used to Treat IPF
    • Pulmonary Rehab for IPF Patients
    • Lung Transplantation for Pulmonary Fibrosis
    • Oxygen Used to Treat IPF
    • Clinical Trials in Idiopathic Pulmonary Fibrosis
    • IPF & Leg Swelling
    • Pulmonary Hypertension and Idiopathic Pulmonary Fibrosis
    • IPF Exacerbation

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