MV130 immunotherapy prevents COPD exacerbations

Treatment with MV130, a sublingual bacterial immunotherapy, reduces the number of exacerbations in patients with chronic obstructive pulmonary disease (COPD), according to a recent study presented at ERS 2021.

“Respiratory tract infections due to viruses and/or bacteria are considered common triggers of COPD exacerbations, … [which] are associated with airway inflammation leading to increased patient morbidity and mortality ... [Previous studies have shown that] sublingual mucosal bacterial immunotherapy (MV130) has been used to reduce infections in various clinical settings,” said presenting author Dr Luis Puente from Universitario Gregorio Marañón in Madrid, Spain.

MV130 is a whole-cell heat-inactivated bacterial vaccine, which contains 90 percent gram-positive* and 10 percent gram-negative** inactivated bacteria, to be administered via the sublingual route two puffs per day.

This phase III, double-blind, placebo-controlled trial analysed 198 patients diagnosed with moderate-to-severe COPD who were recruited from seven hospitals in Spain. Participants were randomized in a 1:1 ratio to receive either MV130 (n=97) or placebo (n=101) daily for a 12-month treatment period and a 6-month follow-up period. [ERS 2021, abstract 207]

During the 18-month study period, the number of COPD exacerbations was lower among patients treated with MV130 compared with placebo (median, 2.0 vs 3.0; p<0.01), with the most pronounced effects among those with severe exacerbations in the MV130 vs placebo group (32 vs 70 patients).

MV130-treated patients also experienced shorter duration of exacerbations (median, 10 and vs 20 days; p<0.01) and antibiotic consumption (median, 12 vs 29 days; p<0.01) compared with placebo-treated patients.

The incidence of adverse events (AEs) was lower in the MV130 group vs the placebo group (115 vs 140 events). There were only two nonserious AEs, cutaneous itching for MV130 and urticaria for placebo, which were considered to be drug related.

“In conclusion, therapeutic immunomodulation with MV130 in COPD reduces the number [and length] of exacerbations, … [as well as] the use of antibiotics,” said Puente.

“Immunotherapy with MV130 is safe in COPD patients, … and it has an excellent safety profile,” he added.

*Gram-positive: V104 Streptococcus pneumoniae, V102 Staphylococcus aureus, and V101 Staphylococcus epidermidis

**Gram-negative: V113 Klebsiella pneumoniae, V105 Moraxella catarrhalis, and V103 Haemophilus influenza