Ventaleon GmbH, a biotechnology company focusing on the development of inhaled treatments against viral infections, today presented data from its Phase II trial with inhaled LASAG (D,L-lysine acetylsalicylate‧ glycine) in severe influenza at the 21st Congress of the International Society for Aerosols in Medicine (ISAM) being held in Santa Fe, NM, USA. LASAG, a compound with a novel antiviral mode of action,
has been shown to inhibit the signaling factor NF-kB that is essential for the replication of influenza viruses. This is believed to be the first time that a host-cell signalling inhibitor with an off-virus effect demonstrated efficacy as an antiviral drug.
Prof. Dr. Oliver Planz, Head of the group “Translational Immunology of Infection” in the
Department of Immunology of University of Tuebingen, Germany., and co-author of the
study, said: “Therapeutic intervention strategies against severe, hospitalized influenza are limited. The data presented at ISAM support that inhaled LASAG in addition to standard of care has the potential to significantly reduce time to alleviation of symptoms in hospitalized patients with severe influenza. I look forward to this treatment being evaluated in larger clinical studies.”
“We are excited with the results presented for inhaled LASAG in patients with severe influenza, as they clearly support advancing this program in development,” said Dr. Ulrich Dauer, CEO of Ventaleon. “We just initiated a Phase Ib challenge study to show the causal effect of LASAG inhalation on the influenza virus, which is an important step in preparing for pivotal trials.”
The randomized, double-blind, placebo-controlled Phase II clinical trial evaluated aerosolized LASAG compared to placebo for the treatment of severe influenza (as shown by composite symptom scores (CSS) ≥14). In addition to standard of care treatment, inhaled LASAG or placebo were administered three times daily in adult hospitalized patients with acute serious influenza. A total of 41 patients (LASAG: n=24; placebo: n=17) completed the study per protocol.
The primary endpoint of the study was time to alleviation of clinical influenza symptoms. The LASAG group showed significantly reduced time to alleviation of symptoms compared to placebo (38.3 hrs vs. 56.2 hrs; Satterthwaite t-test p=0.0365). The secondary endpoint of alleviation of clinical signs (including body temperature and oxygen saturation) was also significantly improved in the LASAG group compared to placebo (24.9 hrs vs. 44.1 hrs; onesided t-test p=0.00246).
LASAG was generally well tolerated with no significant safety differences between the LASAG and placebo groups. Based on the data of this Phase II study together with results from the ongoing Phase Ib challenge trial expected towards year end, Ventaleon will define its pivotal development strategy for this first in class product candidate for severe hospitalized influenza and explore the potential to extend the inhaled LASAG therapy to a broader patient base suffering from viral infections.