Tharimmune, Inc. (Nasdaq: THAR) announced today that the U.S. Food and Drug Administration (FDA) has provided positive feedback on the regulatory pathway for TH104, allowing the company to submit a New Drug Application (NDA) via the 505(b)(2) pathway without conducting additional clinical trials. This expedited approach applies to TH104's development as a prophylactic treatment against respiratory and nervous system depression for individuals potentially exposed to high-potency opioids.
The FDA's decision represents a significant advancement for Tharimmune's development program, which seeks to provide protection for military personnel and chemical incident responders entering areas contaminated with ultrapotent opioids. The company had submitted a Pre-Investigational New Drug Application (PIND) 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 of Tharimmune. "We believe that a rapidly biodegradable buccal film offers prophylactic protection against respiratory distress in such situations represents a crucial advancement."
Leveraging Existing Data for Expedited Development
The foundation for the FDA's decision rests on the extensive existing data related to nalmefene, the approved active ingredient in TH104. Nalmefene has a well-established safety profile through years of use in approved products and demonstrated efficacy for opioid overdose.
Tharimmune will utilize an "in silico" submission approach, which employs computer simulation to predict how TH104 will function as a prophylaxis against opioid exposure. This method combines:
- Detailed pharmacokinetic (PK) data from previous human studies conducted by Tharimmune that characterized the buccal administration of the active ingredient
- Existing published data on nalmefene administered through other routes
- Sophisticated mathematical models to simulate expected drug levels and duration of action
This approach allows for scientifically sound predictions of TH104's behavior in the body without repeating extensive human clinical trials that have already established the fundamental properties of nalmefene. The FDA has recognized the value of this approach for new formulations of well-understood active ingredients.
Dual-Purpose Development Strategy
TH104 is being developed for two distinct indications:
- Moderate-to-severe chronic pruritus in patients with primary biliary cholangitis (PBC), a rare autoimmune liver disease
- Temporary prophylaxis against respiratory and/or nervous system depression for personnel entering areas contaminated with high-potency opioids
The buccal film formulation offers advantages for both indications, with the rapidly biodegradable delivery system providing particular benefits for prophylactic protection against opioid exposure.
Manufacturing and Regulatory Preparation
Tharimmune is actively advancing its Chemistry, Manufacturing, and Controls (CMC) plan to meet the requirements for filing an NDA. This comprehensive plan covers all aspects of the manufacturing process, quality control measures, and product stability to ensure consistent production of the TH104 buccal film formulation.
The 505(b)(2) pathway allows Tharimmune to leverage the established safety and efficacy of nalmefene while expediting the development and potential availability of this important product. The company indicated that more information regarding the FDA's feedback will be made available on its investor relations website in future filings.
About Tharimmune
Tharimmune is a clinical-stage biotechnology company developing therapeutic candidates in immunology, inflammation, and oncology. Beyond TH104, the company's pipeline includes TH023, an oral TNF-alpha inhibitor for autoimmune diseases, and early-stage multispecific biologics targeting unique epitopes against multiple solid tumors through its proprietary EpiClick™ Technology.
The company maintains a license agreement with OmniAb, Inc. to access their antibody discovery technology for targeting specified disease markers.
