APEIRON Biologics inizia la fase II della sperimentazione clinica di APN01 per il trattamento di COVID-19

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La societa’ APEIRON Biologics ha annunciato l’inizio della fase II della sperimentazione clinica del loro prodotto APN01 per il trattamento di COVID-19.

  • Società europea di biotecnologie APEIRON Biologics AG
  • Oggi inizio della sperimentazione clinica per il primo trattamento specifico Covid-19
  • Fase 2 della sperimentazione clinica in tre paesi: Austria, Germania, Danimarca; 200 pazienti
  • Finalizzazione per l’autorizzazione al mercato prevista per il 2020 per Europa con EMA

APN01 ha un’unica e doppia modalità d’azione. APN01 imita l’enzima umano ACE2, che è usato dal virus per entrare nelle cellule. Il virus si lega, quindi, all’ACE2/APN01 solubile, invece che all’ACE2 sulla superficie cellulare, il che significa che il virus non può più infettare le cellule. Allo stesso modo tempo, APN01 riduce le reazioni infiammatorie dannose nei polmoni e protegge da lesione polmonare acuta (acute respiratory distress syndrome, ARDS).

Di seguito il testo completo del Comunicato in lingua inglese:

APEIRON Biologics Initiates Phase II Clinical Trial of APN01 for
Treatment of COVID-19
• Regulatory approvals obtained for the treatment of 200 COVID-19 patients in
Austria, Germany and Denmark; Austrian government to provide significant
financial support
• APN01 has the potential to block the infection of cells by the novel COVID-19
virus and reduce lung injury
• APN01 was previously proven to be safe and well tolerated in Phase I and Phase
II clinical trials
• First patient expected to be dosed shortly
Vienna, Austria, 02 April 2020: APEIRON Biologics AG today announced that it has
received regulatory approvals in Austria, Germany and Denmark to initiate a Phase II
clinical trial of APN01 to treat COVID-19. APN01 is the recombinant form of the human
angiotensin-converting enzyme 2 (rhACE2), and has the potential to block the infection of
cells by the novel SARS-CoV-2 virus (COVID-19), and reduce lung injury. The Phase II trial
aims to treat 200 severely infected COVID-19 patients, and the first patients are expected
to be dosed shortly.
APN01 has a unique dual mode of action. APN01 imitates the human enzyme ACE2, which
is used by the virus to enter cells. The virus binds to soluble ACE2/APN01, instead of ACE2
on the cell surface, which means that the virus can no longer infect the cells. At the same
time, APN01 reduces the harmful inflammatory reactions in the lungs and protects against
acute lung injury (ALI/acute respiratory distress syndrome (ARDS).
“Based on its unique dual mechanism of action, APN01 has the potential to be the first
drug approved to treat COVID-19 that specifically targetsthe new SARS-CoV-2 virus,” said
Peter Llewellyn-Davies, Chief Executive Officer of APEIRON Biologics AG. “We look
forward to dosing the first patient in our Phase II trial shortly, with the goal of providing
a safe and effective treatment option for severely infected COVID-19 patients in urgent
need of help. We are grateful to the regulatory authorities in Austria, Germany and
Denmark for rapidly approving this study, and for the commitment of the Austrian
Government, which has agreed to fund a significant portion of this trial.”
The randomized, double-blind Phase II trial will compare APN01 to placebo in up to 200
patients at 10 sites in Austria, Denmark and Germany. The primary objective of the trial
is to assess the clinical efficacy and safety of APN01 in severe COVID-19 patients using,
among other criteria, the need for invasive mechanical ventilation. Secondary objectives
include the evaluation of measurable biological biomarker changes following treatment
with APN01.
APN01 has been shown to be safe and well-tolerated in a total of 89 healthy volunteers
and patients with pulmonary arterial hypertension (PAH) and ALI/ARDS in previously
completed Phase I and Phase II clinical trials. The product candidate is currently in Phase
II development by APEIRON Biologics for the treatment of PAH and ALI/ARDS, which is a
significant cause of COVID-19-related mortalities.
“Importantly, the novel coronavirus strain SARS-CoV-2 is a very close relative of the first
SARS-CoV virus, which emerged globally in 2002, as it critically relies on the ACE2 receptor
to infect the human cell,” explained Prof. Josef Penninger, MD, co-inventor of APN01,
founder of APEIRON Biologics AG, member of its supervisory board and Professor at the
University of British Columbia. “There is significant scientific evidence suggesting that
treatment with the dual action recombinant human ACE2 can be used to treat patients
with COVID-19. We are blocking the door for the virus and, at the same time, protecting
tissues, which is what ACE2 normally does.”
“We are eager to participate in this very promising and critical study. APN01 is an
advanced drug candidate with a very strong dual rationale that may provide an important
therapeutic contribution to fight the COVID-19 pandemic,” said Prof. Henning
Bundgaard, principal investigator of the study and professor at the Faculty of Health
and Medical Sciences at the University of Copenhagen.
The following centers, among others, will participate in the clinical trial: in Germany, the
University Medical Center Hamburg-Eppendorf and the Klinikum rechts der Isar of the
Technical University of Munich; in Austria, the Medical University of Vienna, the Kaiser
Franz-Josef-Spital, Vienna, the Medical University of Innsbruck and the University Medical
Center Salzburg; in Denmark, the National University Hospital, Rigshospitalet
(Copenhagen), the Herlev Gentofte Hospital, the Hvidovre Hospital, and the
Nordsjællands Hospital (Hillerød).
CTC North GmbH & Co. KG, a medical contract research organization at the University
Medical Center Hamburg-Eppendorf, will be responsible for the study-specific
organization of the clinical trial.
About APN01
APN01 is a recombinant human Angiotensin Converting Enzyme 2 (rhACE2) and was
developed by APEIRON biologics for the treatment of acute lung injury (ALI), acute
respiratory distress syndrome (ARDS) and pulmonary arterial hypertension (PAH). After
licensing from APEIRON in February 2010, GlaxoSmithKline (GSK) conducted several
clinical trials from 2014 to 2017 to treat ALI/ARDS and PAH patients, lung injury being the
major source of Covid-2019 mortalities, the disease caused by the new corona virus SARSCoV-2. In 2019, APEIRON obtained the APN01 licenses back from GSK for further clinical
development, after a their strategic refocusing of GSK to oncology.
The ACE2 receptor is expressed in human airway epithelia as well as lung parenchyma and
was previously identified as the essential gateway used by the first SARS-CoV virus to
infect human cells. ACE2 is also the critical receptor for the new virus SARS-CoV-2 to enter
human cells. Thus, treatment with recombinant human ACE2 could be used to not only
block viremia but also protect lungs and other organs from injury. The drug candidate is
administered intravenously as an infusion and has already shown safety and tolerability
in 89 patients and volunteers.
About APEIRON Biologics AG
APEIRON Biologics is a privately-held European biotech company based in Vienna, Austria,
focused on the discovery and development of novel cancer immunotherapies and
respiratory diseases. APEIRON received EU marketing approval for APN311 (Dinutuximab
beta, Qarziba®) in 2017 for the treatment of pediatric neuroblastoma patients and outlicensed global, exclusive rights for this product to EUSA Pharma Ltd. APEIRON now
leverages its proprietary master checkpoint blockade mechanism to enable the human
body’s natural defense mechanisms to fight the tumor. APEIRON’s clinical program
APN401 is a first-in-class autologous cellular therapy to strengthen immune reactivity via
an intracellular master checkpoint, Cbl-b. APEIRON’s APN01 (rhACE2) is starting a Phase
II trial in Europe to treat COVID-19. APEIRON’s projects and technologies are bolstered by
a strong patent portfolio. APEIRON’s development expertise is validated through
partnerships with leading pharmaceutical companies and academic institutions.
For further information please contact:
APEIRON Biologics AG
Peter Llewellyn-Davies
CEO
Email: apeiron@apeiron-biologics.com
www.apeiron-biologics.com
Media and Investor Relations
MC Services AG
Julia Hofmann
T +49 89 210 228 0
Email: apeiron@mc-services.eu
FORWARD LOOKING STATEMENTS
Information set forth in this press release contains forward-looking statements, which
involve a number of risks and uncertainties. The forward-looking statements contained
herein represent the judgement of APEIRON as of the date of this press release. Such
forward-looking statements are neither promises nor guarantees, but are subject to a
variety of risks and uncertainties, many of which are beyond our control, and which could
cause actual results to differ materially from those contemplated in these forward-looking
statements. We expressly disclaim any obligation or undertaking to release publicly any
updates or revisions to any such statements to reflect any change in our expectations or
any change in events, conditions or circumstances on which any such statement is based.