ATLANTA, September 23, 2021 / PRNewswire / – Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (“Inhibikase” or “Company”), a clinical-stage pharmaceutical company developing therapeutics to treat the course of Parkinson’s disease and related diseases, announced today that the company has been awarded $ 385,388 Research grant from the U.S. National Institute of Neurological Disease and Stroke (NINDS), part of the National Institutes of Health (NIH), to evaluate the therapeutic potential of IkT-148009, the company’s leading c-Abl inhibitor, in a novel Preclinical Study Model for Multiple System Atrophy (MSA).
MSA is a rare, rapidly progressing neurodegenerative movement disorder that affects both the central and autonomic nervous systems. MSA is characterized by a pathological alpha-synuclein aggregation, which can lead to dysfunction of the oligodendroglial cells and degeneration of neurons. Symptoms of MSA reflect this progressive degeneration and manifest as autonomic nervous system failure (i.e. digestion, blood flow and pressure, etc.), parkinsonism, cerebellar ataxia, and pyramidal signs. There are currently no approved therapies to slow or stop the progression of MSA, and there is no cure.
In collaboration with the laboratory of Jeffrey Kordower Ph.D., founding director of the University of Arizona Banner Neurodegenerative Disease Research Center found that pathological alpha-synuclein in oligodendroglial cells contains the same characteristics of c-Abl activation as in Parkinson’s disease. Namely the phosphorylation of a certain tyrosine residue in the pathological alpha-synuclein aggregates1. This grant will allow Inhibikase to study the mechanism of MSA disease process in a new rodent model to determine whether IkT-148009 could have the same therapeutic effect on the disease process as it does in models of Parkinson’s disease. A complementary effort is underway in collaboration with a second rodent model from MSA Erwan Bezard, Ph.D., INSERM Research Director, Institute for Neurodegenerative Diseases of the University Bordeaux and non-executive director of Motac Neuroscience.
“MSA affects approximately 20,000 people in the US who are not approved for appropriate therapies to slow or stop the progression of the disease,” commented Milton Werner, Ph.D., President and Chief Executive Officer of Inhibikase Therapeutics. “This grant will help us model and understand the mechanisms that drive MSA, and we look forward to being recognized by our scientific colleagues at NINDS and NIH. At the same time, we will work with leading experts in the field to create the regulatory framework to introduce IkT-148009 into clinical development for MSA. We believe the continued support from government and nonprofits will serve to further validate the potential of our science, and we look forward to advancing our pipeline for the treatment of neurodegenerative diseases. “
Via IkT-148009
IkT-148009 is a selective c-Abl kinase inhibitor that uniquely inhibits c-Abl and the closely related Abl2 / Arg enzyme, without any other member of the Abl kinase family, namely c-Kit or PDGFRa / b to inhibit. It has almost 20 times the effectiveness of the anti-cancer drug imatinib against c-Abl in enzyme inhibition tests. The clinical development of IkT-148009 in Parkinson’s patients progressed only 5 months after the start of the clinical development program with excellent preclinical and clinical safety profiles and no clinically significant side effects observed to date. The first patient to be administered IkT-148009 is expected to appear early in the fourth quarter of 2021.
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1 (Neurobiology of Disease v. 148, page 105184 (2021). Doi: 10.1016 / j.nbd.2020.105184). |
About multiple system atrophy
Multiple system atrophy (MSA) is a neurodegenerative movement disorder that affects approximately 20,000 people in the United States. It is sporadic and usually shows up between the ages of 35 and 65 with a variable combination of Parkinson’s, cerebellar, and autonomic features that quickly lead to dangerous morbidity. Research into possible treatments for MSA has been limited, leading to a lack of knowledge of the underlying causes, and there are currently no approved treatments to stop the pathological progression. Initial clues to the origins of MSA were obtained from the study of alpha-synuclein and its characteristic histopathology in the brain of patients with MSA. These studies found that MSA is characterized by the presence of glial cytoplasmic inclusions (GCIs), which are predominantly located in oligodendroglial cells. GCIs are made up of abnormal conformations of alpha-synucelin, the same protein that accumulates in neurons and Lewy bodies in Parkinson’s disease (PD) and Lewy body dementia (LBD). Some phenotypes of MSA have little or no clinically relevant parkinsonism and instead present with cerebellar ataxia or dysautonomia, most commonly as orthostatic hypotension. As a level of the variable clinical spectrum, the basal ganglia (substantia nigra, cardate, putamen), the cerebellum (cerebellar cortex and Purkinje cells) and the autonomic nuclei (locus caeruleus, dorsal motor) lead to a very variable oligodendrocyte degeneration, vagus nucleus, intermediolateral Cell column of the spinal cord). Alpha-synuclein inclusions from MSA are able to multiply on neighboring cells and induce neurodegeneration when injected into transgenic mice, suggesting that MSA may be a prion disease. In addition, alpha-synuclein induces deficits in myelination in oligodendrocytes in contrast to the synuclein aggregates in Parkinson’s disease.
About inhibicase (www.inhibikase.com)
Inhibikase Therapeutics, Inc. (Nasdaq: ICT) is a clinical-stage pharmaceutical company developing therapeutics for Parkinson’s disease and related diseases. Inhibikase’s multi-therapeutic pipeline is focused on neurodegeneration and its lead program IkT-148009, an Abelson tyrosine kinase (c-Abl) inhibitor, is aimed at the treatment of Parkinson’s disease inside and outside the brain. Inhibikase has completed its phase 1 studies to evaluate the safety, tolerability and pharmacokinetics of IkT-148009 in elderly and healthy volunteers and has started a phase study 1b Study on Parkinson’s Patients. Its multi-therapeutic pipeline tracks Parkinson’s-related diseases of the brain and gastrointestinal tract, orphaned indications related to Parkinson’s disease such as Multiple System Atrophy or MSA, and drug delivery technologies for kinase inhibitors such as IkT-001Pro, a prodrug of the cancer drug Imatinib, which the company believes will provide a better patient experience with fewer dosing side effects. The company’s RAMPTM medical chemical program has identified a number of follow-up compounds to IkT-148009 that can be used in other cognitive and motor disorders of the brain. Inhibikase is headquartered in Atlanta, Georgia with offices in Boston, Massachusetts.
Social media disclaimer
Investors and others should note that we disclose material financial information to our investors through our investor relations website, press releases, SEC filings, and public conference calls and webcasts. The company also intends to use Twitter, Facebook, LinkedIn and YouTube to disclose information about the company, its services and other matters and to comply 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 conditions and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based on Inhibikase’s current expectations and beliefs. Such statements are subject to risks and uncertainties that could cause Inhibikase’s actual results to differ materially from those anticipated in the forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements are set forth in Inhibikase’s filings with the SEC, including its registration statement on Form S-1, as amended (File Number 333-240036) , including under the heading “Risk Factors”. All forward-looking statements in this press release speak only as of the date of this press release. Inhibikase undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or for any other reason, unless this is required by applicable securities laws.
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