- 600 mg IkT-001Pro
demonstrated bioequivalence to Standard-of-Care 400 mg Dose of
Imatinib mesylate -
- Minimal adverse events with consistent drug
delivery seen across 31 subjects in the pivotal trial -
- Company to submit FDA meeting request to
discuss regulatory approval pathway -
BOSTON and ATLANTA, Aug. 17,
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 the completion of its
bioequivalence study of IkT-001Pro compared to 400 mg imatinib
mesylate.
"We are pleased to announce the completion of the pivotal phase
of our 501 study evaluating IkT001Pro," stated Dr. Milton Werner, President and Chief Executive
Officer of Inhibikase Therapeutics. "The study met expectations and
demonstrated that the 600 mg dose of IkT-001Pro was equivalent to
standard-of-care 400 mg imatinib mesylate. IkT-001Pro demonstrated
a favorable safety and tolerability profile that we are planning to
further differentiate from standard of care by establishing the
bioequivalent dose for high dose 600 mg imatinib mesylate, a dose
that is poorly tolerated in patients. We are preparing to submit a
meeting request to the FDA in the near term to discuss the
requirements for approval under the 505(b)(2) pathway."
The '501' bioequivalence study evaluated IkT-001Pro at four
single ascending doses of 300, 400, 500 and 600 mg in 27 healthy
subjects ranging in age from 18 to 55, followed by a pivotal phase
comparing the 600 mg of IkT-001Pro to 400 mg imatinib mesylate in
31 healthy volunteers. In total, fifty adverse events were observed
following treatment with IkT-001Pro or commercial 400 mg imatinib
mesylate, 24 of which were possibly or probably related to the
administration of either study drug to the participants in the
trial. All adverse events were of mild severity, with the most
common adverse events being muscle aches or pains, headache,
insomnia or a feeling of bloatedness. Imatinib delivered by
IkT-001Pro demonstrated a slower rise time to maximum plasma
concentration (Tmax) of 6 hours, compared to the 4-hour
Tmax of 400 mg imatinib mesylate, but displayed lower
inter-patient variability relative to standard-of-care. Mean and
median maximum plasma concentration (Cmax) and overall
exposure (AUC0-infinity) were approximately 16% higher
for IkT-001Pro relative to 400 mg imatinib mesylate, consistent
with higher total imatinib delivery by 600 mg IkT-001Pro.
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 leukemia1 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
Investors and others should
note that we announce material financial information to our
investors using our investor relations website, press releases, SEC
filings and public conference calls and webcasts. The company
intends to also use Twitter, Facebook, LinkedIn and YouTube as
a means of disclosing information about the company, its services
and other matters and for complying with its disclosure obligations
under Regulation FD.
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).
View original content to download
multimedia:https://www.prnewswire.com/news-releases/inhibikase-therapeutics-announces-completion-of-the-501-bioequivalence-study-of-ikt-001pro-301903289.html
SOURCE Inhibikase Therapeutics, Inc.