Inhibikase Therapeutics Announces Final Pre-IND Meeting Outcomes for IkT-001Pro as a Treatment for Pulmonary Arterial Hypertension

Rhea-AI Summary

Inhibikase Therapeutics, Inc. (Nasdaq: IKT) announced outcomes from the final pre-IND meeting with the FDA for IkT-001Pro as a treatment for Pulmonary Arterial Hypertension. The FDA designated IkT-001Pro as a New Molecular Entity, allowing for exclusivity designations. The Company is preparing the IND application for Pro, a potential branded product for PAH, a deadly disease with treatment options.

Positive

• FDA designates IkT-001Pro as a New Molecular Entity for Pulmonary Arterial Hypertension

• IkT-001Pro could be a branded product with exclusivity designations for an indication of high unmet medical need

• Pro has the potential to be a safer and better-tolerated alternative to existing treatments for PAH

• The Company is actively pursuing partnership discussions to advance Pro into clinical development for PAH

Negative

• The FDA requested a pre-clinical cell culture-based study of the hERG ion channel to compare Pro to imatinib due to cardiovascular concerns

• PAH is a rare disease with approved disease-modifying therapies, posing challenges for market penetration

Insights

Medical Research Analyst

The FDA's recognition of IkT-001Pro as a New Molecular Entity (NME) is quite significant, as it means that this treatment will be granted a period of exclusivity upon approval. This period prevents generic competition and could result in substantial market share and revenue for Inhibikase, especially within the Pulmonary Arterial Hypertension (PAH) space, which has a high unmet medical need. PAH, predominantly affecting a demographic of women aged 30-60, is a niche but serious condition requiring effective treatments. Presently, with limited disease-modifying therapies, any advancement could provide both clinical and commercial benefits. The FDA's agreement to a 505(b)(2) pathway, which allows for a potentially faster approval process by relying on existing data from the active ingredient imatinib, is a strategic advantage. However, the necessity for a pre-clinical study on the hERG ion channel indicates a concern for cardiovascular safety, a common issue in PAH treatments. Investors should track the outcome of this pre-clinical study as it may impact the IND submission timeline. The move to engage strategic partners could be indicative of the company's need to offset development costs and risk, which is a prudent approach for a clinical-stage company.

Financial Analyst

Inhibikase's development of IkT-001Pro for PAH and the subsequent exclusivity designations could lead to a competitive edge in the PAH market, valued at over $7 billion in 2023. The market's projected growth rate of 5.4% from 2024 to 2030 suggests a promising increase in market potential. With an estimated 30,000 PAH cases in the U.S. alone, a successful disease-modifying therapy could capture a significant portion of this market. Considering the current PAH market dynamics, a new entry like IkT-001Pro has the potential to command premium pricing, particularly if it shows a better safety and efficacy profile compared to existing therapies. As an investor, closely observing the company's ability to secure partnerships is key, as it will not only validate the market's interest in the drug but could also provide the necessary resources for its development. The company's stock value could see an appreciable impact based on these developments, but it is essential to consider the inherent risks associated with drug development, such as regulatory hurdles and the results of ongoing pre-clinical studies.

Pharmaceutical Regulatory Expert

The confirmation of IkT-001Pro as a New Molecular Entity and its eligibility for NME exclusivity designations by the FDA underscore the drug's novelty and potential for market protection. The 505(b)(2) regulatory pathway selected for IkT-001Pro expedites the approval process by permitting reliance on existing clinical data of the parent drug, imatinib. This not only accelerates time to market but also lowers development costs, providing a strategic advantage for Inhibikase. In the context of the regulatory environment, a successful pre-IND meeting outcomes and alignment with the FDA are positive indicators for the drug's future development. Nevertheless, the FDA's request for a pre-clinical hERG ion channel study should not be underestimated. The study's results are important as they address cardiac safety—a paramount consideration in PAH treatments. Investors should be aware that the study's results could significantly influence the IND submission and the drug’s development trajectory.

- FDA indicated IkT-001Pro can be considered a New Molecular Entity and is eligible for exclusivity designations in Pulmonary Arterial Hypertension –

BOSTON and ATLANTA, May 09, 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 that the Company has received final meeting minutes from its recent pre-IND meeting with the Division of Cardiology and Nephrology of the U.S. Food and Drug Administration (FDA) for IkT-001Pro (“Pro”) as a candidate treatment for Pulmonary Arterial Hypertension (PAH). Following review of the final meeting minutes, Inhibikase is preparing the Investigational New Drug (IND) application.

“Following our pre-IND discussion with the FDA related to the chemical entity status and path to approval for Pro as a treatment for Pulmonary Arterial Hypertension, the FDA confirmed in final meeting minutes that Pro would be considered a New Molecular Entity (NME) in PAH,” said Dr. Milton Werner, President and Chief Executive Officer of Inhibikase. “This designation opens the path to patent and NME exclusivity for IkT-001Pro even though the FDA agreed that the 505(b)(2) path is appropriate for approval. If approved, IkT-001Pro could be a branded product with all the value drivers of a novel treatment for an indication of high unmet medical need. PAH is a rapidly progressing, often fatal disease affecting primarily women between the ages of 30 and 60. There are several products on the market that address symptoms of the disease, but only one disease-modifying therapy has been approved to date. In previous clinical trial work, imatinib, the active ingredient in Pro, demonstrated that it could be disease-modifying for PAH. We believe that Pro has the potential to be a safer and better tolerated therapeutic option for imatinib treatment and are actively pursuing partnership discussions to advance Pro into clinical development.”

In the final minutes from the pre-IND meeting, the FDA agreed that Inhibikase had built a bridge between imatinib’s use in blood and gastrointestinal cancers and PAH and supported the Company’s Phase 2/3 design as the initial clinical pursuit. The FDA requested the Company complete a pre-clinical cell culture-based study of the hERG ion channel to compare Pro to imatinib as Imatinib has previously been linked with certain cardiovascular abnormalities. The Company intends to complete this 7-day experiment prior to an IND submission. In parallel, the Company has initiated discussions with potential strategic partners in order to advance the development of Pro for Pulmonary Arterial Hypertension.

Pulmonary Arterial Hypertension is a rare disease of the pulmonary microvasculature. PAH can arise spontaneously, or can be caused by genetic mutations, drugs or environmental toxins. PAH is also associated with connective tissue disease (CTD), congenital heart disease and HIV infection. Most treatments for PAH attempt to address symptoms of this progressive disorder, but the recent approval of Winrevair^® highlights that disease-modification is possible. There are approximately 30,000 cases of PAH in the U.S. The global PAH market size was valued at $7.66 billion in 2023 and is estimated to grow at a compound annual growth rate of 5.4% between 2024 to 2030.

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

What did the FDA indicate regarding IkT-001Pro in the final pre-IND meeting?

The FDA designated IkT-001Pro as a New Molecular Entity for Pulmonary Arterial Hypertension, allowing for exclusivity designations.

How many cases of PAH are there in the U.S.?

Approximately 30,000 cases of PAH are reported in the U.S.

What is the estimated global PAH market size in 2023?

The global PAH market size was valued at $7.66 billion in 2023.

What is the compound annual growth rate of the global PAH market from 2024 to 2030?

The global PAH market is estimated to grow at a compound annual growth rate of 5.4% between 2024 to 2030.