BOSTON and
ATLANTA, May 16, 2023
/PRNewswire/ -- Inhibikase Therapeutics, Inc. (Nasdaq: IKT)
(Inhibikase), a clinical-stage pharmaceutical company developing
therapeutics to modify the course of Parkinson's disease and
related disorders, today announced that the first patient has been
dosed in its Phase 2 '201' trial evaluating IkT-148009, the
Company's novel Abelson Tyrosine Kinase, or c-Abl, inhibitor for
the treatment of Parkinson's disease.
"Dosing of the first patient in our '201' trial
completes the first milestone in our revamped Phase 2 program
evaluating the clinical benefit of IkT-148009 for the treatment of
Parkinson's disease and related disorders," commented Milton H. Werner, Ph.D., President and Chief
Executive Officer. "Parkinson's disease remains one of the most
prevalent neurodegenerative disorders and affects more than one
million people in the U.S. annually. Our research has validated the
critical role that c-Abl plays in the initiation and progression of
Parkinson's disease, as well as the potential of IkT-148009 as a
promising new approach to disease modification."
The '201' trial is a 1:1:1:1 randomized,
double-blind, twelve-week dosing trial intending to assess the
safety, tolerability and steady-state pharmacokinetics of
IkT-148009 as primary endpoints. The trial will enroll
approximately 120 patients with untreated Parkinson's disease
(Hoehn & Yahr < 3.0) who have yet to initiate symptomatic
therapy. Patients will be treated at one of three randomized doses,
either 50, 100 or 200 mg given once daily, or to a placebo dose.
The trial will also measure a hierarchy of fifteen
Parkinson's-related disease assessments in the brain and gut as
secondary endpoints and use state-of-the-art assessments in skin
and spinal fluid to measure the effect of treatment on pathological
alpha-synuclein.
Additional information about the trial is
available at www.clinicaltrials.gov using the identifier
NCT05424276.
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 has a primary
focus 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 Abelson Tyrosine Kinase. 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 an office in
Lexington, Massachusetts.
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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, including our ability to successfully conduct clinical
trials, that results in our animal studies may not be replicated in
humans and our ability to maintain our Nasdaq listing. Important
factors that could cause actual results to differ materially from
those in the forward-looking statements include factors that are
delineated 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, Ph.D.
President & CEO
678-392-3419
info@inhibikase.com
Investor Relations:
Alex Lobo
SternIR, Inc.
alex.lobo@sternir.com
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