InfanDx AG Revises Strategy and Broadens Diagnostics Pipeline for Child Health
March 28 2023 - 4:00AM
- After promising top-line data for metabolic biomarkers,
in-depth data analysis revealed BANON study results not
generalizable to HIE patients in clinical routine.
- Development of HypoxE® test based purely on metabolic
biomarkers discontinued accordingly.
- Shareholders unanimously approve expansion of business
strategy into new areas of pediatric health care.
Cologne/Berlin, Germany, and Boston, MA, USA,
March 28, 2023 – InfanDx AG, a privately held company focusing on
the development and commercialization of novel diagnostic solutions
for child health, today announced a strategic repositioning of the
Company by broadening its pipeline of innovative solutions for
child health.
The repositioning follows the discontinuation of
the development of a metabolic biomarker-based test for the early
detection of Hypoxic-Ischemic Encephalopathy (HIE). While top-line
results from a blinded biomarker validation study, BANON, published
in October 2022 looked promising, in-depth analysis of study data
after de-blinding raised serious doubts about the generalizability
of the study data to the intended use population of the HypoxE®
Test.
“Clinical studies are models of clinical reality,” said Dr. Gunter
Weiss, COO of InfanDx. “In our detailed analysis of the BANON
dataset we saw certain subgroup effects that were specific to the
study cohort and therefore not reflective of a broader target
population of the test we intended to develop. When we modeled the
performance of our metabolic biomarker panels in a data subset that
was more reflective of the targeted intended use population, we had
to conclude that the performance was insufficient for an HIE test
to gain acceptance in the medical community. In an approach driven
by our understanding of disease biology, we are now looking at
other biomarker classes to address the pressing issue of the early
detection of HIE.”
In parallel to exploring alternative diagnostic
solutions for the reliable early detection of HIE, the Company will
pursue further novel opportunities in prenatal testing and infant
health with the intention of creating a high-value portfolio that
balances biological, technological, and market risks. Due to
ongoing partnering discussions and intellectual property related
activities, the Company has not disclosed any further details on
such opportunities.
To ensure sufficient financial runway for the
implementation of the new strategy while retaining relevant key
talent, the Company was restructured immediately following the
decision to discontinue the development of the HypoxE® Test based
on metabolic biomarkers as originally planned. It is now well
funded to achieve key milestones in pursuing each of the portfolio
opportunities. Based on such achievements the management expects
the Company to be in a position to raise further funding by
year-end 2023 or early 2o24.
The change in strategy was unanimously approved
by all of the Company’s shareholders at a recent Extraordinary
Shareholder Meeting.
“With the realization that our metabolic
biomarker data did not meet expectations, we were able to rapidly
adapt to the situation and further strengthen our pipeline in
pediatric care by adding two promising development projects to our
portfolio,” commented Dr. Achim Plum, CEO of InfanDx. “This
wouldn’t have been possible without the tremendous trust and
support we received from our Supervisory Board and shareholders who
are fully committed to walk with us on our journey as a new
InfanDx. I would also like to thank the team at InfanDx - those
colleagues we had to part with in the restructuring for their
enormous efforts in executing our original plan, and those
colleagues that stayed for their trust, excellence, and
professionalism in the transition to our new strategy.”
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About InfanDx
InfanDx AG is a privately held company focusing
on the development and commercialization of novel diagnostic
solutions for child health.
Lead by a team of seasoned industry experts, the
Company pursues the development of a portfolio of high-value
diagnostics opportunities in pre-natal testing, neonatal acute and
critical care, and infant health.
The Company is headquartered in Cologne,
Germany, with a branch office in Berlin, Germany, and a wholly
owned subsidiary in Boston, MA, USA.
For more information, please visit:
http://www.infandx.com/
Meet the Management at DBT 2023
For questions and comments, please meet the InfanDx Management
today, March 28, 2023, at
German Biotechnology Days 2023 (DBT 2023) RheinMain
CongressCenter Friedrich-Ebert-Allee 165185 Wiesbaden
Germany
https://www.biotechnologietage.de/en/
For meeting requests, please use the conference
networking portal or contact Mrs. Nathaly Schaefer (see below).
For further information on InfanDx, please
contact:
InfanDx AG Nathaly Schaefer,
Corporate Affairs Manager P: +49 (0) 30 556 535
81info@infandx.com
InfanDx USA, Inc.Jordan deVos (VP
Operations)contact@infandx-usa.com
Media contact akampionDr.
Ludger Wess / Ines-Regina Buth Managing Partners
info@akampion.comTel. +49 40 88 16 59 64 /Tel.
+49 30 23 63 27 68