Inhibikase Therapeutics Completes Enrollment of the Phase 2 ‘201’ Trial Evaluating Risvodetinib in Untreated Parkinson’s Disease
Inhibikase Therapeutics (Nasdaq: IKT) announced the completion of enrollment in its Phase 2 '201' trial of risvodetinib (risvo), a selective c-Abl inhibitor, for untreated Parkinson's disease patients. The 12-week, randomized, double-blind, placebo-controlled trial involves 120 participants across 32 U.S. sites, with the company expecting to report results in Q4 2024. Out of the enrolled participants, 69 have completed the dosing period. To date, 32 mild and 5 moderate adverse events possibly related to the treatment have been reported, with four participants withdrawing early from the study.
- Completion of enrollment in the Phase 2 '201' trial for risvodetinib.
- Trial results expected in Q4 2024.
- 120 participants enrolled across 32 U.S. sites.
- 69 participants have completed the 12-week dosing period.
- Advancement towards discussions with the FDA for pivotal Phase 3 trials.
- 32 mild and 5 moderate adverse events observed possibly related to risvodetinib treatment.
- Four participants withdrew from the trial before completing the 12-week treatment.
Insights
Completion of enrollment in a clinical trial is a significant step for any biotech company, especially one focusing on untreated Parkinson's disease. The trial's design as a randomized, double-blind, multi-center, placebo-controlled study is considered the gold standard for clinical trials. This rigorous methodology lends credibility to the forthcoming results.
From a medical researcher’s perspective, the safety and tolerability data are crucial. While the report mentions 32 mild and 5 moderate adverse events, these numbers need context. Mild and moderate adverse events are common in clinical trials and their impact will depend on the nature and severity of these events. The fact that four participants withdrew suggests that some adverse events may have been significant enough to affect participant retention, a factor that will need close scrutiny when full data are analyzed.
The completion of enrollment implies that the study has reached a stage where it can start providing reliable data. Given the innovative approach of targeting c-Abl inhibitors in Parkinson's, this study could pave the way for novel therapeutic options, pending successful outcomes. Investors should watch for detailed safety and efficacy results expected in Q4 2024, as these will shape the next steps, including potential Phase 3 trials.
For investors, completing enrollment in a Phase 2 trial is a positive milestone. It signals that the company is progressing through its pipeline, a key factor in the valuation of biotech firms. The anticipated results in Q4 2024 could be a catalyst for the stock, depending on their outcome.
Investors should note the financial implications of moving to a Phase 3 trial. Phase 3 trials are significantly more expensive, requiring substantial capital. Therefore, while the current milestone is a positive sign, it also indicates potential future fundraising activities or partnerships. Investors should be cautious of potential stock dilution if the company opts for equity financing.
Moreover, the adverse events and participant withdrawals, while not uncommon, introduce a layer of risk. Financial models should account for the possibility of mixed or negative trial results affecting the stock price.
The completion of enrollment in the Phase 2 trial for risvodetinib positions Inhibikase in a promising but competitive market. Parkinson’s disease affects millions globally and new treatments are eagerly awaited. However, the market is also crowded with both established therapies and numerous emerging contenders.
Risvodetinib’s potential as a disease-modifying treatment is particularly noteworthy. Existing treatments often focus on symptom management rather than modifying disease progression. If risvodetinib shows positive results, it could capture a significant market share, providing a differentiated therapeutic option.
However, market analysts should also consider the competitive landscape. Any delays or adverse results could shift market sentiment quickly. Moreover, the eventual pricing strategy and market access will play important roles in the drug’s commercial success.
Company expects to report trial results in 4Q24
BOSTON and ATLANTA, June 17, 2024 (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, Parkinson's-related disorders and other diseases of the Abelson Tyrosine Kinases, today announced the company has completed enrollment in the Phase 2 ‘201’ trial evaluating the safety and tolerability of risvodetinib (“risvo”), a potent selective c-Abl inhibitor, for treatment in untreated Parkinson’s patients. The company expects to report trial results in the fourth quarter of 2024.
"The completion of enrollment for the 201 Trial in untreated Parkinson’s disease represents a major milestone for Inhibikase,” said Dr. Milton H. Werner, President and Chief Executive Officer of Inhibikase. “This achievement reflects the hard work of our team, the success of our proprietary and innovative patient identification and referral service and the commitment of our 32 U.S. study sites to evaluating potential disease-modifying solutions for patients with this debilitating disease. With enrollment in the study now complete, we look forward to reporting trial results in the fourth quarter, and the discussion with the FDA on our plans for pivotal Phase 3 trials by the end of the year.”
The 201 Trial is a 12-week, randomized, double-blind, multi-center, placebo-controlled clinical trial evaluating three risvo doses in patients with untreated Parkinson’s disease to assess safety, tolerability and efficacy of risvo in untreated Parkinson’s disease. The trial has enrolled all 120 participants across 32 sites across the United States, and expects to randomize 126 patients total so as not to exclude already screened participants from participating in the trial. As of June 17, 2024, 69 participants have completed the 12-week dosing period. To-date, there have been 32 mild and 5 moderate adverse events observed that may be related to risvo treatment. Four people withdrew from the trial without completing 12 weeks of treatment.
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 several follow-on compounds to risvodetinib that could potentially be applied to other cognitive and motor function diseases of the brain. Inhibikase is headquartered in Atlanta, Georgia with offices in Lexington, Massachusetts.
Social Media Disclaimer
Investors and others should note that the Company announces material financial information to investors using its 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 enroll and complete the 201 Trial evaluating risvodetinib in untreated Parkinson’s disease, to successfully apply for and obtain FDA approval for IkT-001Pro in blood and stomach cancers or other indications, to successfully conduct clinical trials that are statistically significant and whether results from our animal studies may 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, PhD
President & CEO
678-392-3419
info@inhibikase.com
Investor Relations:
Alex Lobo
Stern Investor Relations, Inc.
alex.lobo@sternir.com
FAQ
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