- 600 mg dose of IkT-001Pro
selected as the bioequivalent dose relative to
standard of care 400 mg imatinib mesylate -
- On-track to complete pivotal clinical phase
of the 501 study by the end of 2Q22 -
BOSTON and ATLANTA, June 22,
2023 /PRNewswire/ -- Inhibikase Therapeutics, Inc.
(Nasdaq: IKT) ("Inhibikase" or "Company"), a clinical-stage
pharmaceutical company developing protein kinase inhibitor
therapeutics to modify the course of Parkinson's disease,
Parkinson's-related disorders and other diseases of the Abelson
Tyrosine Kinases, today announced that it has selected the
bioequivalent dose of IkT-001Pro, the Company's prodrug formulation
of imatinib mesylate designed to enhance the safety and efficacy of
imatinib (marketed as Gleevec®) in patients with Chronic
Myelogenous Leukemia (CML) and provided an update on its '501'
bioequivalence study.
The '501' bioequivalence study has evaluated IkT-001Pro at four
single ascending doses of 300, 400, 500 and 600 mg, leading to the
selection of 600 mg IkT-001Pro as the bioequivalent dose to 400 mg
imatinib mesylate. The pivotal phase of the study was dosed with
bioequivalent IkT-001Pro in 31 healthy volunteers; one subject was
excluded pre-dose due to aberrant clinical laboratory values. The
Company expects to complete the pivotal clinical phase of the study
by the end of the second quarter.
"Based on the safety signals we have seen at the 600 mg dose of
IkT-001Pro relative to 400 mg imatinib mesylate, we believe that we
have identified the appropriate go-forward dose for
standard-of-care treatment with IkT-001Pro," stated Dr.
Milton Werner, President and Chief
Executive Officer of Inhibikase Therapeutics. "We plan to add an
additional cohort to the '501' trial in the third quarter to
evaluate bioequivalence of IkT-001Pro relative to 600 mg imatinib
mesylate with repeat dosing. 600 mg imatinib mesylate is commonly
used to treat CML, but is poorly tolerated by up to 50% of
patients. We believe IkT-001Pro may overcome the poor tolerability
of high dose imatinib experienced by many patients, further
differentiating the advantage of IkT-001Pro over current
standard-of-care."
Following the completion of the '501' trial, Inhibikase will
initiate a discussion with the FDA on the parameters for approval
of IkT-001Pro under the 505(b)(2) statute.
About IkT-001Pro
IkT-001Pro is a prodrug formulation
of imatinib mesylate and has been developed to improve the safety
of the first FDA-approved Abelson
(Abl) kinase inhibitor, imatinib (marketed as
Gleevec®). Imatinib is commonly taken for hematological
and gastrointestinal cancers that arise from Abl kinase mutations
found in the bone marrow or for gastrointestinal cancers that arise
from c-Kit and/or PDGFRa/b mutations in the stomach; c-Kit,
PDGFRa/b and Abl are all members of the Abelson Tyrosine Kinase
protein family. IkT-001Pro has the potential to be a safer
alternative for patients and may improve the number of patients
that reach and sustain major and/or complete cytogenetic responses
in stable-phase CML and/or reduce the relapse rate for these
patients. In preclinical studies, IkT-001Pro was shown to be as
much as 3.4 times safer than imatinib in non-human primates,
reducing burdensome gastrointestinal side effects that occur
following oral administration. Imatinib delivered as IkT-001Pro was
granted Orphan Drug Designation for stable-phase CML in
September 2018.
About Chronic Myelogenous Leukemia
Chronic
myeloid leukemia[1] is a slowly progressing cancer that affects the
blood and bone marrow. In CML, a genetic change takes place in
immature myeloid cells — the cells that make most types of white
blood cells. This change creates an abnormal gene product called
BCR-ABL which transforms the cell into a CML cell. Leukemia cells
increasingly grow and divide in an unregulated manner, eventually
spilling out of the bone marrow and circulating in the body via the
bloodstream. Because they proliferate in an uncontrolled manner,
the excessive production of myeloid cells acts like a liquid tumor.
In time, the cells can also settle in other parts of the body,
including the spleen. CML is a form of slow-growing leukemia that
can change into a fast-growing form of acute leukemia that is
difficult to treat.
About Inhibikase
(www.inhibikase.com)
Inhibikase
Therapeutics, Inc. (Nasdaq: IKT) is a clinical-stage pharmaceutical
company developing therapeutics for Parkinson's disease and related
disorders. Inhibikase's multi-therapeutic pipeline focuses on
neurodegeneration and its lead program IkT-148009, an Abelson
Tyrosine Kinase (c-Abl) inhibitor, targets the treatment of
Parkinson's disease inside and outside the brain as well as other
diseases that arise from Ableson Tyrosine Kinases. Its
multi-therapeutic pipeline is pursuing Parkinson's-related
disorders of the brain and GI tract, orphan indications related to
Parkinson's disease such as Multiple System Atrophy, and drug
delivery technologies for kinase inhibitors such as IkT-001Pro, a
prodrug of the anticancer agent imatinib mesylate that the Company
believes will provide a better patient experience with fewer
on-dosing side-effects. The Company's RAMP™ medicinal chemistry
program has identified a number of follow-on compounds to
IkT-148009 to be potentially applied to other cognitive and motor
function diseases of the brain. Inhibikase is headquartered in
Atlanta, Georgia with offices in
Boston, Massachusetts.
Social Media Disclaimer
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note that we announce material financial information to our
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Forward-Looking Statements
This press release contains
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. Forward-looking
terminology such as "believes," "expects," "may," "will," "should,"
"anticipates," "plans," or similar expressions or the negative of
these terms and similar expressions are intended to identify
forward-looking statements. These forward-looking statements are
based on Inhibikase's current expectations and assumptions. Such
statements are subject to certain risks and uncertainties, which
could cause Inhibikase's actual results to differ materially from
those anticipated by the forward-looking statements. Important
factors that could cause actual results to differ materially from
those in the forward-looking statements include our ability to
satisfactorily address the issues raised by the FDA in order to
have the clinical hold on our IkT-148009 programs removed, as well
as such other factors that are included in our periodic reports on
Form 10-K and Form 10-Q that we file with the U.S. Securities and
Exchange Commission. Any forward-looking statement in this release
speaks only as of the date of this release. Inhibikase undertakes
no obligation to publicly update or revise any forward-looking
statement, whether as a result of new information, future
developments or otherwise, except as may be required by any
applicable securities laws.
Contacts:
Company Contact:
Milton H.
Werner, PhD
President & CEO
678-392-3419
info@inhibikase.com
Investor Relations:
Alex
Lobo
SternIR, Inc.
alex.lobo@sternir.com
1 1 Also known as chronic myelogenous leukemia,
chronic myelocytic leukemia, and chronic granulocytic leukemia
(CGL).
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SOURCE Inhibikase Therapeutics, Inc.