Tharimmune Advances TH104 for Prophylaxis Against Weaponized Fentanyl and Other High-Potency Opioids Following Positive FDA Feedback

TECHNOLOGY 28.04.2025

BRIDGEWATER, NEW JERSEY / ACCESS Newswire / April 28, 2025 / Tharimmune, Inc., (Nasdaq:THAR) ("Tharimmune" or the "Company") a clinical-stage biopharmaceutical company focused on developing innovative therapeutics in inflammation & immunology, recently announced positive feedback from the U.S. Food and Drug Administration (FDA) regarding TH104. The agency confirmed that no additional clinical trials appear to be necessary prior to a 505(b)(2) New Drug Application (NDA) submission. TH104 is a buccal film formulation, of nalmefene specifically designed for rapid absorption with a potential for bypassing liver metabolism. This allows TH104 to be suitable for the temporary prophylaxis of respiratory and/or nervous system depression in military personnel and chemical incident responders who may be exposed to high-potency opioids, including weaponized fentanyl and its analogues.

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This significant regulatory milestone underscores the urgent need for specialized medical countermeasures highlighted in a recent market assessment concerning the United States Strategic National Stockpile (SNS). This assessment specifically addressed the growing threat posed by chemicals of concern, with a primary focus on the increasing risk of high-potency synthetic opioids like fentanyl and its numerous derivatives being weaponized and deployed as aerosolized agents.

The U.S. government has increasingly recognized fentanyl and its related compounds as significant national security threats due to their extreme potency and the potential for mass casualty incidents if weaponized. These substances, significantly more potent than traditional opioids, pose a grave risk through inhalation, dermal contact, or ingestion. The 2002 Moscow theater hostage crisis, where aerosolized synthetic opioids were reportedly used, tragically demonstrated the devastating potential of such agents in a mass casualty scenario. This event, alongside intelligence indicating potential adversary interest in opioid-based chemical weapons, has heightened the priority for developing effective prophylactic measures for frontline personnel/first responders.

SNS market assessment identified a critical need for countermeasures that can be administered prior to or immediately upon potential exposure to these agents, preventing or mitigating the rapid onset of respiratory and nervous system depression. Key findings from this analysis further emphasize the importance of Tharimmune's work:

DoD Focus on Prophylaxis: The Department of Defense (DoD) is proactively addressing this threat through its procurement of a naloxone auto-injector, explicitly indicated for temporary prophylaxis against high-potency opioids for military personnel and chemical incident responders operating under their authority.
Civilian Preparedness and Response: SNS, managed by the Administration for Strategic Preparedness and Response (ASPR), a part of Department of Health and Human Services (HHS). ASPR maintains over 1974 containers in 1330 locations throughout the USA, to ensure timely availability of antidotes to chemicals of concern to civilian population.
TH104 as a Promising Solution: Tharimmune's TH104, with its buccal film delivery and potential for a longer duration of action compared to existing naloxone formulations, offers a promising investigational countermeasure tailored to the demanding operational environments faced by military and civilian responders. Compared with current administration modes (intramuscular injections), the buccal administration route is potentially advantageous when personnel are wearing full protective gear.

"The positive feedback from the FDA on the NDA pathway for TH104 is a crucial step forward in addressing a critical national security concern - the potential weaponization of fentanyl and its derivatives," said Randy Milby, CEO of Tharimmune. "The market assessment clearly articulates the need for more options as effective prophylactic solutions for those on the front lines. TH104's novel formulation and pharmacokinetic profile could provide a significant advantage in protecting military personnel and chemical incident responders from the immediate and life-threatening effects of opioid exposure in contaminated environments."

The development of TH104 aligns directly with the U.S. government's increasing focus on preparedness against chemical threats, particularly those involving highly potent opioids. The positive FDA feedback provides a clear impetus for Tharimmune to continue its development program and work towards making this potentially life-saving prophylactic available to those who need it most.

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. For more information, please 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]

Alliance Advisors IR
Tirth T. Patel
[email protected]
212-201-6614

SOURCE: Tharimmune Inc.

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