Based on proof-of concept Phase II clinical study data and results from an ongoing Phase Ib challenge trial, Ventaleon will define the pivotal development strategy for its first in class product candidate to treat severe hospitalized influenza and explore the potential to extend the inhaled LASAG therapy to a broader patient base suffering from viral infections.
The proof-of-concept study, a randomized, double-blind, placebo-controlled Phase II clinical trial in influenza patients with moderate to severe symptoms demonstrated a more rapid, clinically relevant and significant symptom decline when administered via inhaled LASAG compared to standard of care. Aerosolized LASAG or placebo were administered three times daily in 41 hospitalized adult patients with acute serious influenza.
LASAG showed an accelerated alleviation of symptoms by over 1 day and an even more pronounced alleviation of clinical signs in severe and very severe hospitalized influenza patients. The efficacy of LASAG increased with the severity of disease symptoms. LASAG was generally well tolerated with no significant safety differences between the LASAG and placebo groups.
The anti-viral activity of LASAG is currently being assessed in a human challenge trial, in healthy volunteers infected with the H3N2 subtype of the influenza A virus. The single-centre, randomized, double-blind, placebo-controlled Phase Ib study includes 80 volunteers randomized into three arms (2:2.1) inhaled LASAG plus oral placebo, inhaled placebo plus oral placebo and inhaled placebo and oral acetylsalicylic acid (ASA). The study aims to prove the anti-viral activity of inhaled LASAG and the superiority of inhaled LASAG vs. systemic ASA in the clinical setting.