Data from a Phase 2 trial examining BI 10115550, an oral treatment for idiopathic pulmonary fibrosis (IPF), has just been released. This data shows that this therapy is able to slow the decline of lung function in patients regardless of if they were also taking other approved antifibrotic treatments.
This therapy will now move to a Phase 3 clinical trial in August 2022. The goal is to bring this treatment to IPF patients as soon as possible.
This treatment works to block phosphodiesterase 4B activity which is an enzyme which causes inflammation. By blocking the activity of this enzyme, anti-inflammatory or antifibrotic effects are witnessed.
Researchers are examining the potential of this therapy not only for IPF but for other progressive interstitial lung diseases (ILDs), which are all characterized by scarring of tissue in the lungs. This treatment has already been FDA given breakthrough therapy designation.
Phase 2 Trial
The findings of this Phase 2 trial were published in The New England Journal of Medicine.
The aim of the investigation was to examine the safety and the efficacy of the treatment in IPF patients (both those taking antifibrotics and those who were not). There were 147 patients enrolled in the trial across 22 countries and 90 trial sites. Most participants were male, and the average age of participants was 70. All patients were 40 years of age or older and had a forced vital capacity, or FVC, of at least 45% as well as no IPF exacerbation in the last 4 months. The primary endpoint of the trial was changes in FVC, which measures the amount of air someone can exhale forcibly after taking a deep breath.
All patients were randomized to either receive 18mg of the treatment or placebo twice each day for three months.
This trial met its primary endpoint, demonstrating that the treatment was superior to placebo at slowing the decline of lung function. For patients not taking another antifibrotic, the treatment increased FVC by 5.7mL. For those in this group given placebo, there was a 81.7mL reduction.
For patients already taking another treatment, those given the therapy experienced a 2.7mL increase, whereas those given placebo had a 59.2mL decrease. For both groups, the probability of the novel treatment having a superior effect compared to placebo was 98%.
The most common side effect reported by patients was mild diarrhea. The researchers are excited to report that no new safety issues with the treatment were documented.
Phase 3 Trial
The upcoming Phase 3 trial will include 642 patients with a minimum age of 40. All patients in this upcoming trial will need to not have experienced a worsening in disease for the prior 3 months. The clinical trial sites for this Phase 3 investigation will be released soon.
Additionally, another Phase 3 trial will be initiated shortly to examine the therapy in other progressive lung conditions.
You can read more about this novel therapy and what it could mean for patients here.