GH Research Announces Grant of European Patent Covering all Mebufotenin (5-MeO-DMT) and Mebufotenin Salt Products For Use in the Treatment of Major Depressive Disorder and Treatment-Resistant Depression
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Insights
The granting of the European Patent EP3927337 to GH Research PLC for the use of mebufotenin (5-MeO-DMT) in treating major depressive disorder (MDD) and treatment-resistant depression (TRD) is a significant milestone. It not only provides the company with an exclusive right to prevent others from commercially exploiting the patented technology in Europe until at least 2040, but it also enhances the company's competitive edge in the market for rapid-acting antidepressants. This patent protection is crucial for recouping R&D investments and incentivizing further innovation in the psychiatric and neurological treatment landscape.
From a legal standpoint, the patent's claims covering various routes of administration, including pulmonary inhalation, intravenous and intranasal, indicate a broad scope of protection for GH Research's technology. This breadth is essential for safeguarding the company's market position against potential generic entrants. Moreover, the mention of overcoming third-party observations suggests the patent's robustness and may deter litigation or opposition proceedings, which can be costly and time-consuming.
The strategic move by GH Research to secure patent rights in Europe and to pursue similar protections in the US and other jurisdictions reflects a proactive approach to creating a global moat around its key asset, mebufotenin. Investors should note the potential for increased market exclusivity that can lead to revenue growth, especially in a market where treatment-resistant forms of depression represent a significant unmet medical need. The anticipation of additional patents relating to various aspects of mebufotenin therapies indicates a deepening of the company's IP portfolio, which could be a strong indicator of future value creation and a diversified risk profile.
It is also noteworthy that the company's IP strategy is grounded in early priority dates and clinical data, which may provide a defensible position against competitors. The market will likely respond positively to this news, as it demonstrates GH Research's commitment to innovation and may signal future partnerships or licensing deals that could further monetize the company's IP assets.
The therapeutic application of mebufotenin (5-MeO-DMT) for MDD and TRD represents a novel approach within the mental health care sector. The ability of GH Research to secure patent protection for this compound suggests that their clinical data might be showing promise in addressing these challenging conditions. For healthcare professionals and patients, the development of new treatment options is critical, particularly for those who are not responding to existing therapies.
The patent's coverage of multiple administration routes provides flexibility in treatment protocols and could lead to improved patient adherence and outcomes. The company's research and development efforts in expanding the applications of mebufotenin, as indicated by its broad patent applications, could lead to advancements in personalized medicine for mental health disorders, ultimately benefiting patient care and outcomes.
DUBLIN, Ireland, Jan. 18, 2024 (GLOBE NEWSWIRE) -- GH Research PLC (Nasdaq: GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the treatment of psychiatric and neurological disorders, today announced that it recently received a communication from the European Patent Office (EPO) that it has been granted a patent with claims directed to mebufotenin (5-MeO-DMT) or a pharmaceutically acceptable salt thereof for use in treating patients diagnosed with major depressive disorder (MDD) and treatment-resistant forms of MDD, such as treatment-resistant depression (TRD).
The newly granted patent, EP3927337, which will have an effective date of February 14, 2024, and an expiry date of no earlier than 2040, is expected to cover all mebufotenin (5-MeO-DMT) and mebufotenin salt products for use in the treatment of MDD and TRD, including but not limited to products administered through pulmonary inhalation, intravenous and intranasal routes. It is therefore expected to effectively fortify the company’s position at the forefront of novel rapid-acting antidepressant treatments. Similar patent applications are pending on behalf of the company in the US and in over thirty other jurisdictions, aiming to provide broad coverage in all key geographies for the therapeutic use of mebufotenin (5-MeO-DMT) in MDD and TRD.
The present grant represents the first of many expected milestones for GH Research’s intellectual property (IP) portfolio as the company continues to advance its additional more than 25 unique international patent applications, that relate to various further aspects of mebufotenin (5-MeO-DMT) therapies, including use for treatment of various disorders via inhaled, nasal, buccal, sublingual, intravenous, intramuscular or subcutaneous routes; novel aerosol compositions of matter; novel manufacturing methods for preparation and purification; novel salt forms; and novel delivery device-related features.
Theis Terwey, CEO and Co-founder of GH Research said: “We are committed to providing highly effective new therapies to patients in mental health care who are underserved by existing treatments. Having a strong IP portfolio helps us with this mission, and it is satisfying to have the EPO endorse the strength of our IP. We believe the EPO’s grant of this patent, in view of various third-party observations submitted during the examination process, reflects the fact that our IP portfolio is characterized by early priority dates and is underpinned by the earliest clinical data on the use of mebufotenin to treat mental illness. We feel well placed to progress the rest of our patent portfolio through the examination process in Europe, the US and beyond, and are looking forward to exploring additional opportunities with mebufotenin through continuous research and development.”
About GH Research PLC
GH Research PLC is a clinical-stage biopharmaceutical company dedicated to transforming the treatment of psychiatric and neurological disorders. GH Research PLC's initial focus is on developing its novel and proprietary mebufotenin (5-MeO-DMT) therapies for the treatment of patients with treatment-resistant depression (TRD).
GH Research PLC's annual report on Form 20-F/A filed with the U.S. Securities and Exchange Commission for the year ended December 31, 2022, is available at www.ghres.com and shareholders may receive a hard copy free of charge upon request.
About GH001
Our lead product candidate, GH001, is formulated for mebufotenin (5-MeO-DMT) administration via a proprietary inhalation approach. With GH001, we have completed two Phase 1 healthy volunteer clinical trials and a Phase 1/2 clinical trial in patients with TRD. Based on the observed clinical activity, where
About GH002 and GH003
GH002 is our mebufotenin (5-MeO-DMT) product candidate formulated for administration via a proprietary intravenous approach. GH002 is currently in Phase 1 clinical development. GH003 is our mebufotenin (5-MeO-DMT) product candidate formulated for administration via a proprietary intranasal administration approach. GH003 is currently in preclinical development. We anticipate developing GH002 and GH003 in subpopulations and confined use scenarios within our focus area of psychiatric and neurological disorders.
Forward-Looking Statements
This press release contains statements that are, or may be deemed to be, forward-looking statements. All statements other than statements of historical fact included in this press release, including statements regarding our future results of operations and financial position, business strategy, product candidates, medical devices required to deliver these product candidates, research pipeline, ongoing and currently planned preclinical studies and clinical trials, regulatory submissions and approvals, including our plans and expectations for discussions with the FDA and the outcomes and resolution of such discussions related to the clinical hold on the GH001 IND, research and development costs, cash runway, timing and likelihood of success, as well as plans and objectives of management for future operations are forward-looking statements. Forward-looking statements appear in a number of places in this press release and include, but are not limited to, statements regarding our intent, belief or current expectations. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including, but not limited to, those described in our filings with the U.S. Securities and Exchange Commission. No assurance can be given that such future results will be achieved. Such forward-looking statements contained in this press release speak only as of the date hereof. We expressly disclaim any obligation or undertaking to update these forward-looking statements contained in this press release to reflect any change in our expectations or any change in events, conditions, or circumstances on which such statements are based unless required to do so by applicable law. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.
Investor Relations:
Julie Ryan
GH Research PLC
investors@ghres.com
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