subslover
1 year ago
Inhibikase Therapeutics Receives FDA Orphan Drug Designation for Risvodetinib for the Treatment of Multiple System Atrophy
BOSTON and ATLANTA, Oct. 04, 2023 (GLOBE NEWSWIRE) -- 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.
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 X, 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 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.
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conix
3 years ago
JonesTrading Thinks Inhibikase Therapeutics’ Stock is Going to Recover
Howard Kim
May 20, 2022,
In a report released today, Soumit Roy from JonesTrading reiterated a Buy rating on Inhibikase Therapeutics (IKT – Research Report), with a price target of $6.00. The company’s shares closed last Friday at $0.63, close to its 52-week low of $0.62.
According to TipRanks.com, Roy is a 3-star analyst with an average return of 3.7% and a 29.7% success rate. Roy covers the Healthcare sector, focusing on stocks such as Deciphera Pharmaceuticals, Adaptimmune Therapeutics, and Actinium Pharmaceuticals.
Currently, the analyst consensus on Inhibikase Therapeutics is a Moderate Buy with an average price target of $6.00.
conix
3 years ago
Recent Developments and Upcoming Milestones:
Phase 1b clinical trial of IkT-148009: The Phase 1b study is a 3:1 randomized, placebo-controlled dose escalation trial evaluating the safety, tolerability, and pharmacokinetics of seven-day dosing of IkT-148009 at three escalating dose levels. The study is also assessing motor and non-motor function, gut motility, and measures of alpha-synuclein aggregate clearance as exploratory endpoints. In March, the Company presented data from the first cohort at the Alzheimer's & Parkinson's Diseases Conference (AD/PD™). Data demonstrated that the safety and tolerability profile in patients closely matched that of older healthy volunteers. Pharmacokinetics of IkT-148009 in volunteers and subjects was also similar, indicating that IkT-148009 pharmacology is consistent across the patient groups and penetrates the Central Nervous System. The Company expects to complete dosing of the Phase 1b study in the second quarter of 2022 and present full data at a medical meeting later this year.
Phase 1 dose escalation of IkT-148009 in older and elderly healthy volunteers: Inhibikase continues to evaluate IkT-148009 in older and elderly healthy volunteers as part of the Phase 1 study. The Company has completed dose escalation studies through 325 mg. To date, no clinically significant adverse events have been observed at any dose.
Phase 2a clinical study for IkT-148009 in patients with Parkinson's Disease: Inhibikase expects to dose the first patient in a Phase 2a study of IkT-148009 in untreated Parkinson's Disease in the second quarter of 2022, subject to agreements with the FDA. The 3:1 randomized, double-blind, twelve-week dosing trial will evaluate the safety and tolerability of three doses of IkT-148009 in up to 120 patients diagnosed with Parkinson's disease who have not yet progressed to the need for symptomatic therapy. The trial will also measure motor and non-motor function inside and outside of the brain as secondary endpoints and evaluate whether treatment with IkT-148009 leads to a reduction or clearance of pathogenic alpha-synuclein aggregates as exploratory endpoints.
Investigational New Drug application (IND) for IkT-001Pro for stable-phase Chronic Myelogenous Leukemia (CML): IkT-001Pro is the Company's prodrug formulation of Imatinib mesylate, designed as a potentially safer, better tolerated treatment for Imatinib-sensitive cancers such as stable-phase Chronic Myeloid Leukemia (CML). The Company is completing clinical batch manufacturing of pill formulated IkT-001Pro and conducting required stability studies and expects to submit the IND for IkT-001Pro in the second quarter of 2022. The Company expects to commence bioequivalence studies in accordance with the 505(b)(2) regulatory pathway agreements with the FDA.
Preclinical studies evaluating IkT-148009 in animal models of Multiple System Atrophy (MSA) in preparation for Phase 2 clinical studies: Inhibikase expects to report preclinical data studying IkT-148009 in at least one of two animal models of MSA prior to dosing of MSA patients. The studies are evaluating whether inhibition of the Abelson Tyrosine Kinase, or c-Abl, could have a therapeutic benefit in MSA. The potential role of c-Abl in the disease process was highlighted in the Company's recent publication published in the peer reviewed journal Neurobiology of Disease[1]. Depending on the preclinical results in animal models of MSA and subject to agreement with the FDA and equivalent regulatory bodies in the European Union, Inhibikase may advance IkT-148009 into a Phase 2a clinical study in the third quarter of 2022.
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