The Albany Gazette - Tharimmune Secures Key Global Patents for TH-104, Laying Foundation for Broader Indications Following Initial Development as a National Security Medical Countermeasure Against Weaponized Fentanyl

This announcement follows recent positive feedback from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) pathway for TH-104. The FDA confirmed that a 505(b)(2) NDA submission for the prevention of respiratory and/or central nervous system distress is a viable path, and no additional clinical trials seem to be required for this specific indication for use in military personnel and/or first responders who may be exposed to weaponized high-potency opioids, such as fentanyl or its analogues. This positive feedback, combined with the appointment of counter-terrorism expert James Liddy to the Board of Directors, accelerates the Company's efforts to position TH-104 as a national security solution.

The recent granting and allowance of patents in Japan, Mexico, Australia, and the United States further strengthen the Company's intellectual property position, providing protection for TH-104 out to at least 2040 in key markets. While the initial focus is on military and first responders, these patents are foundational for addressing other significant medical needs to combat pruritus, a debilitating form of itch associated with certain chronic liver and kidney diseases.

TH-104 is a buccal film formulation of nalmefene, an opioid antagonist with a significantly longer half-life compared to existing options of autoinjectors and other formulations containing the active ingredient of products such as Narcan^®. This extended duration may provide sustained protection, which is crucial for personnel operating in high-risk environments where repeated dosing may not be feasible.

"The recent patent grants are important for our TH-104 platform," said Sireesh Appajosyula, CEO of Tharimmune. "This is a dual achievement which validates our innovative drug delivery technology and secures the long-term potential of TH-104 to address multiple high-impact indications. While we are prioritizing its role as a life-saving medical countermeasure for our military and first responders, this patent portfolio provides a runway to develop our lead candidate for other debilitating conditions where there is a significant unmet medical need."

The newly granted and allowed patents specifically cover a novel method and device for transmucosal administration of nalmefene via a single-layer, self-supporting, mucoadhesive film with distinct domains for optimized drug delivery and pH balance.

The granted and allowed patents include:

• United States (US) Application No. 17/285,971 (Allowed)

• Japan (JP) Patent No. 7603583 (Granted)

• Mexico (MX) Patent No. 422769 (Granted)

• Australia (AU) Patent Application No. 2019361980 (Allowed)

Tharimmune is dedicated to advancing TH-104 to provide a potentially effective and patient-friendly treatment as an option for those in need, beginning with its critical role in national security.

About Tharimmune, Inc.

Tharimmune is a clinical-stage biotechnology company developing a diverse portfolio of therapeutic candidates in immunology, inflammation and oncology. Its lead clinical asset, TH104, is being developed for a specific indication via a 505(b)2 pathway for respiratory and/or nervous system depression in military personnel and chemical incident responders who may encounter environments contaminated with high-potency opioids. The expanded pipeline includes other indications for TH104, such as chronic pruritus in primary biliary cholangitis and TH023, a new approach to treating autoimmune diseases along with an early-stage multispecific biologic platform targeting unique epitopes against multiple solid tumors through its proprietary EpiClick^™ Technology. The Company has a license agreement with OmniAb, Inc. to access their antibody discovery technology for targeting specified disease markers. Tharimmune continues to position itself as a leader in patient-centered innovation while working to deliver long-term value for shareholders. For more information, visit: www.tharimmune.com.

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, contained in this press release, including statements regarding the timing and design of Tharimmune's future Phase 2 trial, Tharimmune's strategy, future operations, future financial position, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words "anticipate," "believe," "continue," "could," "depends," "estimate," "expect," "intend," "may," "ongoing," "plan," "potential," "predict," "project," "target," "should," "will," "would," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The Company may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements. Factors that may cause such differences, include, but are not limited to, those discussed under Risk Factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2024 and other periodic reports filed by the Company from time to time with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date of this release. Subsequent events and developments may cause the Company's views to change; however, the Company does not undertake and specifically disclaims any obligation to update or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by applicable law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this release.

Contacts:

Tharimmune, Inc.
[email protected]

SOURCE: Tharimmune Inc.

View the original press release on ACCESS Newswire

(B.Ramirez--TAG)