Ventaleon presents Phase II results with inhaled LASAG in severe influenza at ISAM Congress 2017

  • Study evaluated efficacy and safety of inhaled LASAG for treatment of severe
    influenza in hospitalized patients compared to standard of care treatment alone
  • Significant reduction in time to alleviation of symptoms and of clinical signs
  • No significant safety differences between LASAG and placebo

Gemuenden, Germany, 07 June, 2017 – 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 21
st 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-
B 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.

For further information, please contact:

Contact
Ventaleon GmbH
Dr. Ulrich Dauer, CEO
Tel.: +49-6453-58530-40
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Media Inquiries
MC Services AG
Katja Arnold, Dr. Brigitte Keller
Tel: +49 89 21022 0
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About Ventaleon GmbH: www.ventaleon.com

Ventaleon GmbH is a biotechnology company focused on the development of inhaled
treatments against viral infections. The Company’s lead therapy candidate is an inhaled form
of LASAG (D,L-lysine acetylsalicylate‧ glycine), which it is developing to treat severe influenza.
A proof-of-concept study in influenza patients with moderate to severe symptoms
demonstrated more rapid symptom decline when administered inhaled LASAG compared to
standard of care. The Company is currently preparing to enter a pivotal clinical trial with inhaled
LASAG. Ventaleon was founded as a spin-off from Activaero and is supported by a group of
leading international investors, including Coöperatief LSP U.A,, BioMedInvest II LP, Abalis
Finance AG, Vesalius Biocapital I S.A., Venture Incubator AG, CatheyWorldInvestment Ltd.
and BayBg