Pasithea Therapeutics Announces Invention of Crystalline Form of PAS-004; Establishes Strengthened Intellectual Property (IP) Position
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Insights
Patent extensions in the biotechnology sector are critical for maintaining exclusivity and ensuring return on investment in drug development. Pasithea Therapeutics' announcement of patent filings for a crystalline form of PAS-004 represents a strategic move to protect their intellectual property well into the future. Extending patent life from 2032 to 2045 can have significant financial implications, as it may effectively prolong the period during which Pasithea can capitalize on their innovation without generic competition. This extension is a common practice known as 'patent evergreening' which can be controversial, but is legal and widely used in the pharmaceutical industry.
For stakeholders, the extended protection provides assurance of potential market exclusivity, which is a key factor in forecasting revenue streams. However, the actual issuance of these patents is not guaranteed and will depend on the novelty and non-obviousness of the invention. If granted, these patents will likely increase the company's valuation and attractiveness to investors. It's important to note that while extending patent life can be beneficial for a company, it may also affect healthcare costs and access to new treatments for patients.
The extension of patent protection for PAS-004 until at least 2045 could position Pasithea Therapeutics favorably in the Central Nervous System (CNS) treatment market. The CNS market is highly competitive and characterized by a constant need for innovative treatments. By securing longer patent protection, Pasithea may gain a competitive edge, as the extended timeframe could deter competitors from developing similar drugs and allow the company to establish PAS-004 as a standard treatment before facing generic competition.
From a market perspective, the extension also signals Pasithea's commitment to the long-term commercial viability of PAS-004. The company's collaboration with Jones Day, a firm with a strong IP biotech practice, may increase investor confidence in the robustness of the company's patent strategy. The upcoming phase 1 dose escalation trial's utilization of the newly invented crystalline drug substance could be a key milestone, potentially impacting the company's stock price as successful trial results may lead to increased investor optimism regarding the drug's market potential.
The invention of a crystalline form of a drug substance like PAS-004 can be pivotal in the pharmaceutical industry. Crystalline forms can offer advantages such as improved stability, bioavailability and ease of manufacturing, which are critical factors in drug development and commercialization. The announcement of the phase 1 dose escalation trial using the new crystalline form suggests that Pasithea Therapeutics is advancing in the drug development process, which is a positive sign for potential investors and partners.
However, it's important to scrutinize the underlying science and the potential clinical benefits of the new form. The actual impact on the treatment of CNS disorders will depend on the clinical trial outcomes. Successful trials can lead to significant value creation, while any setbacks could adversely affect the company's prospects. It's also essential to consider the regulatory pathway and the likelihood of FDA approval, which will ultimately determine the drug's fate in the market.
-- Polymorph and Stereoisomer Patents when Issued Extend Portfolio to at least 2045 --
-- Polymorph and Stereoisomer Patent Filings Continue to Expand Patent Portfolio --
SOUTH SAN FRANCISCO, Calif. and MIAMI, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a clinical stage biotechnology company focused on the discovery, research, and development of innovative treatments for Central Nervous System (CNS) disorders, today announced the invention of a crystalline form of PAS-004 which is captured in polymorph and stereoisomer patent filings that when issued we believe will extend patent protection to at least 2045.
Chief Development Officer Dr. Graeme Currie stated, “Through the invention of the crystal structure for PAS-004 and subsequent patent filings, we are pleased to extend and strengthen the PAS-004 patent portfolio which we believe extends current protection from 2032 to at least 2045. We worked closely with Jones Day, a top global law firm with a premier IP biotech practice, to reach this important milestone.”
Chief Executive Officer Dr. Tiago Reis Marques added, “Through additional chemistry, manufacturing, and controls (CMC) development we believe that we continue to increase the value of PAS-004. We are pleased that our upcoming phase 1 dose escalation trial will utilize the newly invented crystalline drug substance.”
About PAS-004
PAS-004 is a small molecule allosteric inhibitor of MEK 1/2, which are dual-specificity protein kinases, in the MAPK signaling pathway. The MAPK pathway has been implicated in a variety of diseases, as it functions to drive cell proliferation, differentiation, survival and a variety of other cellular functions that, when abnormally activated, are critical for the formation and progression of tumors, fibrosis and other diseases. MEK inhibitors block phosphorylation (activation) of extracellular signal-regulated kinases (ERK). Blocking the phosphorylation of ERK can lead to cell death and inhibition of tumor growth. Existing FDA approved MEK inhibitors are marketed for a range of diseases, including certain cancers and neurofibromatosis type 1 (NF1). We believe these MEK inhibitors suffer from certain limitations, including known toxicities. Unlike current FDA approved MEK inhibitors, PAS-004 is macrocyclic, which we believe may lead to improved pharmacokinetic and safety (tolerability) profiles. Cyclization offers rigidity for stronger binding with drug target receptors. PAS-004 was designed to provide a longer half-life with what we believe is a better therapeutic window. Further, we believe the potency and safety profile that PAS-004 has demonstrated in preclinical studies may also lead to stronger and more durable response rates and efficacy, as well as better dosing schedules. PAS-004 has been tested in a range of mouse models of various diseases and has completed preclinical testing and animal toxicology studies. Additionally, PAS-004 has received orphan-drug designation from the FDA for the treatment of NF1.
About Pasithea Therapeutics Corp.
Pasithea is a biotechnology company focused on the discovery, research and development of innovative treatments for central nervous system (CNS) disorders and RASopathies. With an experienced team of experts in the fields of neuroscience, translational medicine, and drug development, Pasithea is developing new molecular entities for the treatment of neurological disorders, including Neurofibromatosis type 1 (NF1), Solid Tumors, and Amyotrophic Lateral Sclerosis (ALS).
Forward Looking Statements
This press release contains statements that constitute “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include all statements, other than statements of historical fact, regarding the Company’s current views and assumptions with respect to future events regarding its business, including, without limitation, statements about PAS-004, including the Company’s ability to increase its value and to extend its patent protection, as well as other statements with respect to the Company’s plans, assumptions, expectations, beliefs and objectives, the success of the Company’s current and future business strategies, product development, preclinical and clinical studies, clinical and regulatory timelines, market opportunity, competitive position, business strategies, potential growth opportunities and other statements that are predictive in nature. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of the Company. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to the Company on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including, without limitation, the Company’s ability to increase the value of PAS-004 and to extend its patent protection, and other factors set forth in the Company’s most recent Annual Report on Form 10-K, Quarterly Report on Form 10-Q and other filings made with the U.S. Securities and Exchange Commission. Thus, actual results could be materially different. The Company undertakes no obligation to update these statements whether as a result of new information, future events or otherwise, after the date of this release, except as required by law.
Pasithea Therapeutics Contact
Patrick Gaynes
Corporate Communications
pgaynes@pasithea.com
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