-Received positive feedback on New Drug Application submission via the 505(b)(2) pathway
-Company leveraging existing human pharmacokinetic data with TH104
-Advancing CMC plan to meet requirements of a New Drug Application
BRIDGEWATER, NJ / ACCESS Newswire / March 31, 2025 / Tharimmune, Inc. (Nasdaq:THAR) ("Tharimmune" or the "Company"), a clinical-stage biotechnology company focused on immunology and inflammation, today announced in addition to developing TH104 for the proposed indication of moderate-to-severe chronic pruritus in patients with primary biliary cholangitis ("PBC"), which utilizes an approved active ingredient, now formulated as a buccal film, Tharimmune is seeking to develop TH104 for the additional proposed indication of "Temporary Prophylaxis of Respiratory and/or Nervous System Depression in Military Personnel and Chemical Incident Responders Entering an Area Contaminated with High-Potency Opioids", for which we have submitted a Pre-Investigational New Drug Application ("PIND"). With respect to our PIND for this additional proposed indication for TH104, Tharimmune recently received positive feedback from the U.S. Food and Drug Administration (FDA) regarding a regulatory pathway that will allow the Company to submit a 505(b)(2) New Drug Application (NDA) for TH104. Importantly, the FDA has confirmed that no additional clinical trials will be required prior to NDA submission for this indication.
"This feedback from the FDA marks a significant milestone for Tharimmune and for individuals who may face the threat of ultrapotent opioid exposure," said Randy Milby, CEO. "We believe that a rapidly biodegradable buccal film offers prophylactic protection against respiratory distress in such situations represents a crucial advancement. The 505(b)(2) pathway along with leveraging the established safety and efficacy of the active ingredient, allows us to expedite the development and potential availability of this important product without the need for further clinical trials."
The foundation for the FDA's alignment on the submission of a 505(b)(2) NDA without additional clinical trials rests on the extensive existing data related to the approved active ingredient nalmefene embedded in TH104. This includes a comprehensive understanding of its safety profile, established through years of use in approved products, and evidence of its efficacy for opioid overdose. Coupling this wealth of information with the Company's pharmacokinetic (PK) data enables Tharimmune to build a model that will serve for an "in silico" submission. This type of submission refers to analyses conducted via computer simulation, allowing researchers to predict how TH104 will work as a prophylaxis against opioid exposure.
Specifically, by inputting detailed data from previous human studies conducted by Tharimmune that characterized the PK of the active ingredient via buccal administration as well as existing published data through other routes of administration, sophisticated mathematical models can simulate the expected drug levels and duration of action achievable with TH104. This approach allows for a scientifically sound prediction of TH104 behavior in the body without the need to repeat extensive human clinical trials that have already established the fundamental PK properties of nalmefene. The FDA recognizes the value of this approach when a new formulation or route of administration is being developed for a well-understood active ingredient.
Furthermore, Tharimmune is actively progressing its Chemistry, Manufacturing, and Controls (CMC) plan to meet the stringent requirements for filing an NDA with the FDA. This comprehensive plan encompasses all aspects of the manufacturing process, quality control measures, and product stability to ensure the consistent production of a high-quality buccal film formulation known as TH104. More information regarding the FDA's feedback will be made available on the investor relations section of Tharimmune's website in future filings.
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, aims to suppress chronic pruritus associated with primary biliary cholangitis (PBC), a rare autoimmune liver disease with no known cure. The expanded pipeline includes TH023, an oral TNF-alpha inhibitor offering a new approach to treating autoimmune diseases. Tharimmune is also advancing early-stage multispecific biologics 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.
