Inhibikase Therapeutics Receives FDA Orphan Drug Designation for Risvodetinib for the Treatment of Multiple System Atrophy
October 04 2023 - 8:30AM
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 ("PD"), Parkinson's-related disorders and other
diseases of the Abelson Tyrosine Kinases, today announced that
risvodetinib (IkT-148009) has been granted Orphan Drug Designation
by the U.S. Food and Drug Administration (FDA) for the treatment of
Multiple System Atrophy (MSA).
“We are pleased to receive orphan drug
designation for risvodetinib in MSA underscoring the high unmet
medical need in this patient population. There are currently no
approved symptomatic or disease-modifying therapies for MSA on the
market. MSA is an aggressive form of Parkinsonism, leading to death
four times faster than a diagnosis of Parkinson’s disease and we
believe that risvodetinib could potentially slow or halt the
progression of disease. As we look ahead, we are advancing our
ongoing animal model studies of risvodetinib to determine its
therapeutic potential to block progression and correct functional
loss in MSA. These studies will form the basis of our planned Phase
2 clinical study and we look forward to providing further updates
on the potential timing of the Phase 2 trial in the coming
quarters. We believe proof that risvodetinib is clinically
beneficial in MSA will form a basis for potential success in other
forms of Parkinsonism,” noted Dr. Milton Werner, Chief Executive of
Inhibikase Therapeutics.
In 2022, Inhibikase published data demonstrating
that c-Abl is activated in the brains of patients diagnosed with
MSA and that c-Abl modifies alpha-synuclein aggregates as part of
the disease process. In March 2023, the Company received IND
clearance for its planned Phase 2 clinical studies in MSA and
presented preclinical data in August 2023, showing that
risvodetinib could be therapeutically active in models of disease,
at the Movement Disorder Society Congress in Copenhagen,
Denmark.
The FDA’s Orphan Drug Designation program
provides orphan status to drugs or biologics intended for the
prevention, diagnosis, or treatment of diseases that affect fewer
than 200,000 people in the United States. Sponsors of medicines
that are granted Orphan Drug Designation are entitled to certain
incentives and regulatory assistance, including tax credits for
qualified clinical trials, prescription drug user-fee exemptions,
and potential seven-year marketing exclusivity upon FDA
approval.
About Multiple System Atrophy
Multiple System Atrophy (MSA) is a rapidly progressive orphan
disease affecting the central and autonomic nervous systems. MSA is
characterized by pathological alpha-synuclein aggregation, which
may lead to organ dysfunction and degeneration of neurons. Although
it is significantly debilitating and fatal, it is classified as a
rare disease, with a prevalence of 3.6 to 4.9 cases per 100,000
people in the U.S. population. MSA affects men and women equally,
with onset of symptoms typically occurring in the fifth or sixth
decade of life. Rapid progression of the disease results in
patients becoming wheelchair bound in many cases, with varying
combinations of extrapyramidal dysfunction, cerebellar ataxia,
dysautonomia and parkinsonism. Currently, no disease-modifying or
symptomatic therapies exist for MSA.
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 risvodetinib, 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
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
risvodetinib 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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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 successfully conduct clinical trials and
that results in our animal studies may not be replicated in humans,
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, PhDPresident &
CEO678-392-3419info@inhibikase.com
Investor Relations:Alex LoboSternIR,
Inc.alex.lobo@sternir.com
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