Palobiofarma S.L. Announces Positive Top-Line Results from the Phase 2 Trial of Oral PBF-680 in Moderate-to-Severe COPD patients.
Primary endpoint was achieved, with PBF-680 demonstrating a statistically significant reduction in blood eosinophil count over 4 weeks
Reduction in blood eosinophil count correlated with statistically significant reduction in important cytokines and inflammatory markers.
PAMPLONA, SPAIN, SEPTEMBER 9th, 2024—Palobiofarma is pleased to announce today positive top-line results in a Phase 2 trial of the novel oral drug PBF-680 in patients with moderate-to-severe COPD.
The clinical study met its primary endpoint, with PBF-680 10 mg once daily demonstrating a statistically significant reduction in blood eosinophil count (BEC) from Baseline to Week 4 compared to placebo when added to standard of care. The magnitude of change in blood BEC was consistent with the eosinophil depletion seen in previous clinical trials of PBF-680 in asthmatics patients.
In the Phase II trial, eosinophil depletion in blood by oral PBF-680 correlated with clinically important improvements in several important TH2 cytokines like IL-5 and key inflammatory markers like TNFalpha.
PBF-680 was well tolerated by patients at all doses tested. The most common adverse events observed in the study were infections and exacerbations of COPD, without meaningful differences in frequency between placebo and PBF-680. 92% of the patients were on triple therapy: a combination of inhaled corticosteroids, long-acting β2 agonists and long-acting M3 antagonists.
“The obtained Phase 2 results strongly support continuing development of PBF-680 as a potential first-in-class oral agent for the treatment of eosinophilic respiratory diseases,” said Julio Castro, Ph.D., President and CEO of Palobiofarma. “We are extremely glad to confirm in COPD patients the significant positive effects of PBF-680 that we have already observed in asthmatics. We are actively looking for partners to continuing the clinical development of PBF-680 towards marketing approval.”
The completed study was a randomized, double-blind, Phase 2 trial assessing the efficacy and safety of 10mg of oral PBF-680 vs. placebo in reducing blood eosinophil counts over 4 weeks in 103 adult subjects with moderate-to-severe eosinophilic COPD, that were treated with a combination of inhaled corticosteroids and bronchodilators. The trial was conducted at 12 study centers in Spain. Palobiofarma is working with the principal investigator of the trial to present the study results at a forthcoming medical meeting.
Multiple clinical trials with approved eosinophil-depleting drugs have shown that drugs that reduce blood eosinophil counts provide significant benefit for reduction in asthma exacerbations in patients with moderate-to-severe eosinophilic asthma and COPD. Treatments approved to date are only for eosinophilic asthma and are monoclonal antibodies requiring injection or infusion, while PBF-680 is administered orally.