Medexus Completes Enrollment in Phase 4 Clinical Trial of IXINITY® Targeting Label Expansion for Pediatric Hemophilia B Patients
August 12 2021 - 6:30AM
Medexus Pharmaceuticals Inc. (the “
Company”
or “
Medexus”) (TSX: MDP) (OTCQX: MEDXF) today
announced that is has completed enrollment in its Phase 4 Clinical
Trial of IXINITY®, targeting label expansion for pediatric
hemophilia B patients.
The Trial is investigating IXINITY® as a
prophylactic treatment for pediatric patients under 12 years of age
with hemophilia B, a hereditary bleeding disorder characterized by
a deficiency of clotting factor IX. IXINITY® is currently an FDA
approved intravenous recombinant factor IX therapeutic for use in
patients 12 years of age or older with hemophilia B.
Medexus has now enrolled its last patient in
this Phase 4 Clinical Trial, with the trial expected to be complete
in June 2022. On completion, the Company believes this study may
support an expansion of the indicated patient population for
IXINITY®. According to the World Federation of Hemophilia ‘Report
on the Annual Global Survey 2017,' approximately 1 in 3 patients
treated for hemophilia B in the U.S. are 12 years of age or
younger.
Khaled Mohamed, Director of Regulatory Affairs
for Medexus, commented, “We are pleased to have enrolled our final
patient for the IXINITY® Phase 4 pediatric clinical trial. We are
hopeful that this study will allow us to expand the product label
to include the U.S. pediatric population below 12 years of age. We
believe this could prove to be a vital, additional therapy option
to the pediatric population and look forward to submitting the full
data set to FDA by end of 2022.”
Ken d’Entremont, Chief Executive Officer of
Medexus, noted, “The hemophilia B market in the U.S. alone is
estimated to be in excess of USD $1 billion1. A label expansion
inclusive of the pediatric market represents a significant market
opportunity for IXINITY®. Previously reported and pooled data
from Phase 3 clinical trials demonstrated IXINITY® to be safe and
well tolerated in preventing and controlling bleeding episodes in
treated children under the age of 12 with hemophilia B. If
approved, we expect to be well positioned to commercialize quickly
with the infrastructure we already have in place for the adult
market. Additionally, we expect our research and development
expenses will come down once the final dose has been
administered.”
Medexus intends to continue to pursue
out-license partners for IXINITY® in markets outside of Canada and
the United States. The Company will provide further updates as it
achieves key milestones.
1The Marketing Research Bureau Inc., “The Factor
IX Market in the United States 2018”, extracted from “The Plasma
Proteins Market in the United States 2018”, customized report for
Aptevo BioTherapeutics, LLC, August 2019
About Medexus
Medexus is a leader in innovative rare disease
treatment solutions with a strong North American commercial
platform. From a foundation of proven best in class products
we are building a highly differentiated company with a portfolio of
innovative and high value orphan and rare disease products that
will underpin our growth for the next decade. The Company’s vision
is to provide the best healthcare products to healthcare
professionals and patients, through our core values of Quality,
Innovation, Customer Service and Teamwork. Medexus Pharmaceuticals
is focused on the therapeutic areas of hematology, auto-immune
disease, and allergy. The Company’s leading products are: Rasuvo™
and Metoject®, a unique formulation of methotrexate (auto-pen and
pre-filled syringe) designed to treat rheumatoid arthritis and
other auto-immune diseases; IXINITY®, an intravenous recombinant
factor IX therapeutic for use in patients 12 years of age or older
with Hemophilia B – a hereditary bleeding disorder characterized by
a deficiency of clotting factor IX in the blood, which is necessary
to control bleeding; and Rupall®, an innovative prescription
allergy medication with a unique mode of action. The Company has
also licensed treosulfan, a preparative regimen for allogeneic
hematopoietic stem cell transplantation to be used in combination
with fludarabine, from medac GmbH for Canada in the United
States.
For more information, please
contact:
Ken d’Entremont, Chief Executive OfficerMedexus Pharmaceuticals
Inc.Tel.: 905-676-0003E-mail: ken.dentremont@medexus.com
Marcel Konrad, Chief Financial OfficerMedexus Pharmaceuticals
Inc.Tel.: 312-548-3139E-mail: marcel.konrad@medexus.com
Investor Relations (U.S.):Crescendo Communications, LLCTel.:
+1-212-671-1020Email: mdp@crescendo-ir.com
Investor Relations (Canada):Tina ByersAdelaide CapitalTel.:
905-330-3275E-mail: tina@adcap.ca
Forward looking and other cautionary
statements
Certain statements made in this press release
contain forward-looking information within the meaning of
applicable securities laws (“forward-looking
statements”). The words “anticipates”, “believes”,
“expects”, “will”, “plans” and similar expressions are often
intended to identify forward-looking statements, although not all
forward-looking statements contain these identifying words.
Specific forward-looking statements contained in this news release
include, but are not limited to, statements with respect to the
timing for completion of the Phase 4 trial and submission of the
related data set to the FDA, the possibility of an FDA approval for
a label expansion and ability of commercialize thereafter, and the
anticipated decrease in research and development expenses. These
statements are based on factors or assumptions that were applied in
drawing a conclusion or making a forecast or projection, including
assumptions based on historical trends, current conditions and
expected future developments.
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