– Topline results expected by end of 2019 –
PITTSBURGH–(BUSINESS WIRE)–Noveome Biotherapeutics, Inc., a clinical-stage biopharmaceutical
company focused on developing next-generation biologics for the
promotion and restoration of cellular integrity of inflamed or damaged
tissues, today announced the dosing of the first patient in its Phase 2
open label, multi-center clinical trial evaluating topical ocular
delivery of ST266 for the treatment of persistent corneal epithelial
defects (PEDs), for which there are limited treatment options.
“The dosing of the first patient in our Phase 2 clinical trial marks an
important milestone for Noveome as we continue to explore ST266’s
safety, efficacy and broad therapeutic applicability. We believe that
ST266 has the potential to provide an innovative treatment option as a
novel cell-free platform biologic based on the results we have seen to
date in both preclinical and clinical trials demonstrating a strong
safety profile,” said William J. Golden, Founder, Chairman and Chief
Executive Officer of Noveome. “In this trial, we will measure both the
magnitude and speed of response, as well as the number of completely
healed patients and the time to complete healing in the study eye of PED
patients.”
The Phase 2 open label, multi-center clinical trial will evaluate the
safety and efficacy of topical delivery of ST266 in patients with PEDs.
The primary endpoint of the clinical trial is to complete healing as
determined by fluorescein dye after 28 days of therapy. Each patient
will receive a total of 4 doses per day of ST266 over the course of 28
days in the study eye. More information about the study is available at www.clinicaltrials.gov
under the identifier NCT03687632. Topline results are expected later in
2019.
About Persistent Corneal Epithelial Defects (PEDs)
PEDs are non-healing wounds of the cornea caused by trauma, surgery and
infection for which there are limited treatment options. Failure of the
epithelial cells in the cornea to migrate and close the wound can lead
to scarring and possibly perforation and blindness, especially in
patients with severe dry eye and diabetes.
About ST266
ST266 is a cell-free “platform” biologic containing hundreds of proteins
and other factors involved in cellular healing, protection of the brain
and nerves, and modulation of inflammation. The components of ST266 are
secreted by a novel population of cells generated by a proprietary
method of culturing amnion-derived epithelial cells collected from full
term placentas, which are normally discarded after birth. This
“secretome” contains physiologic levels of multiple growth factors and
cytokines and stimulates a variety of anti-inflammatory and
neuroprotective responses in preclinical studies. In addition to central
nervous system (CNS) conditions, ST266 is being evaluated in
ophthalmologic, pulmonary and gastrointestinal conditions. The ST266
platform biologic enables the use of a scalable manufacturing process to
produce quantities for all indications, A drug master file has been
submitted with the FDA, supporting all ST266 investigational new drug
(IND) applications.
About Noveome Biotherapeutics, Inc.
Noveome Biotherapeutics, Inc. is a clinical-stage biopharmaceutical
company focused on developing next-generation biologics for the
promotion and restoration of cellular integrity of inflamed or damaged
tissues. Noveome’s multi-target platform biologic and lead product,
ST266, is currently being evaluated in multiple indications across CNS,
ophthalmic, pulmonary and gastrointestinal therapeutic areas. Noveome is
planning to start a Phase 1 open label clinical trial to establish the
safety of ST266 when delivered intranasally in 2Q 2019 as well as a
Phase 2/3 clinical trial of ST266 in patients with cataracts in 4Q 2019.
In addition to the clinical pipeline, preclinical results testing ST266
in chronic traumatic encephalopathy (CTE), emphysema and necrotizing
enterocolitis (NEC) are also expected later in 2019. The Company
received seed funding from Lancet Capital, a venture capital consortium
of leading Pittsburgh healthcare institutions including UPMC
Enterprises, Highmark Blue Cross/Blue Shield, University of Pittsburgh
and Carnegie Mellon University. To date, Noveome has received over $120
million in research and infrastructure funding from the U.S. Department
of Defense, the Commonwealth of Pennsylvania and Allegheny County.
Noveome is based in Pittsburgh, PA. For more information, please visit, www.noveome.com.
Contacts
Investor:
Julie Seidel
Stern Investor Relations, Inc.
212-362-1200
julie.seidel@sternir.com