Inhibikase Therapeutics, Inc. develops clinical-stage protein kinase inhibitor therapeutics for cardiopulmonary disease, with IKT-001, an oral prodrug of imatinib mesylate, as its lead program for pulmonary arterial hypertension. Company news centers on the IMPROVE-PAH clinical program, FDA interactions, clinical-development milestones, and PAH biology involving Abelson tyrosine kinase, platelet-derived growth factor receptors and c-KIT.
Recurring updates also cover operating results, development spending, equity compensation under Nasdaq rules, common-stock and warrant financing activity, and leadership or commercial-planning changes tied to the PAH program.
Inhibikase Therapeutics (Nasdaq: IKT) announced a new publication detailing the role of Abelson Tyrosine Kinase (c-Abl) inhibition in treating Parkinson's disease. The paper, published on November 24, 2021, highlights the disease-modifying potential of IkT-148009, a selective c-Abl kinase inhibitor. Preclinical studies indicate that this therapy can clear alpha-synuclein aggregates and promote neuron regeneration. Currently, IkT-148009 is in a Phase 1b trial to assess safety and efficacy, with results expected in 2022.
Inhibikase Therapeutics (Nasdaq: IKT) reported its Q3 2021 financial results, highlighting a net loss of $4.5 million, or $0.18 per share, compared to a loss of $0.7 million in Q3 2020. The company dosed its first patient in the Phase 1b trial of IkT-148009 for Parkinson's disease, which aims to assess safety and tolerability. Additionally, they expanded the trial to higher doses and submitted interim toxicology data to the FDA. Inhibikase also received a grant from the NIH to study IkT-148009 for Multiple System Atrophy.
Inhibikase Therapeutics, Inc. (Nasdaq: IKT) announced that Dr. Milton Werner, CEO, will participate in the Michael J. Fox Foundation Alpha-Synuclein Summit on November 3-4, 2021. Dr. Werner will present on the role of c-Abl in neurodegeneration and neuroinflammation in Parkinson's disease and share data on IkT-148009, a c-Abl inhibitor, showcasing its potential as a treatment option. His presentation will be followed by a panel discussion on strategies to address alpha-synuclein pathology in patients.
Inhibikase Therapeutics (Nasdaq: IKT) announced the dosing of the first patient in its Phase 1b clinical trial for IkT-148009, a c-Abl inhibitor targeting Parkinson's disease. The randomized, placebo-controlled study will enroll 24 patients to evaluate safety, tolerability, and pharmacokinetics. Previous Phase 1 results indicated no significant adverse events in 56 healthy volunteers. The c-Abl target may help restore neuron function and mitigate disease effects. Inhibikase aims to progress to a Phase 2a study in 2022, pending Phase 1b outcomes.
Inhibikase Therapeutics, Inc. (Nasdaq: IKT) announced interim three-month results from chronic toxicology studies for its oral drug IkT-148009, aimed at treating Parkinson's disease. The studies, involving rats and non-human primates, revealed an improved toxicology profile with increased NOAEL measurements, suggesting enhanced safety with prolonged dosing. Following FDA review of these results, Inhibikase plans to initiate a Phase 2a study in 2022, evaluating IkT-148009's effects on up to 120 Parkinson's patients. The selective c-Abl kinase inhibitor demonstrates promising potential for better safety and tolerability.
Inhibikase Therapeutics (Nasdaq: IKT) announced a $385,388 research grant from the U.S. National Institute of Neurological Disease and Stroke to evaluate IkT-148009 in a preclinical model for Multiple System Atrophy (MSA). This grant supports research to understand MSA mechanisms and explore the therapeutic potential of IkT-148009, a selective c-Abl kinase inhibitor, which has shown promise in treating Parkinson's disease. Currently, no approved therapies exist for MSA, impacting approximately 20,000 individuals in the U.S.
Inhibikase Therapeutics, Inc. (Nasdaq: IKT) announced that CEO Dr. Milton Werner will present at the H.C. Wainwright 23rd Annual Global Investment Conference from September 13-15, 2021. The presentation is scheduled for September 13 at 7:00 AM ET. A webcast will be available on Inhibikase's website for on-demand viewing, with an archived replay accessible for 30 days post-event. Inhibikase focuses on developing therapeutics for Parkinson's disease and related conditions, including their lead program IkT-148009, which has completed Phase 1 studies and is underway in Phase 1b trials.
Inhibikase Therapeutics (Nasdaq: IKT) reported a net loss of $2.6 million for Q2 2021, compared to $0.4 million in Q2 2020. R&D expenses surged to $2.4 million, driven by clinical trial costs. The company initiated a Phase 1b study for IkT-148009, aimed at treating Parkinson's disease, and plans to submit 13-week toxicology studies to the FDA. They also expect to file an IND for IkT-001Pro for Chronic Myeloid Leukemia in Q3 2021. Cash reserves stand at $46.8 million, expected to fund operations until mid-2023.
Inhibikase Therapeutics (Nasdaq: IKT) announced FDA clearance for a Phase 1b extension study of IkT-148009, a drug targeting Parkinson's disease, after positive safety and tolerability results from a Phase 1 trial in healthy volunteers. This next phase will evaluate the drug's effects on Parkinson's patients, following promising outcomes in preclinical studies. With no significant adverse events reported among 42 subjects in the initial trial, the company aims to advance its therapeutic pipeline, addressing a disease affecting over 1 million individuals in the U.S.
Inhibikase Therapeutics, Inc. (NASDAQ: IKT) announced the closure of its public offering of 15 million shares at $3.00 each, raising gross proceeds of $45 million. This funding aims to support a Phase 1b extension study for IkT-148009 targeting Parkinson's disease, production for upcoming clinical trials, and general R&D activities. The underwriters also have a 45-day option to purchase an additional 2.25 million shares. The offering was registered with the SEC and the final prospectus is available online.