BRIDGEWATER -
We are pleased with the outcome of our recently received feedback from the FDA and are excited to progress the development program for our novel buccal delivery asset, TH104 for pruritus in PBC patients, said
TH104, the Company s lead clinical product candidate is designed to avoid the liver s first-pass metabolism of oral formulations and, as such, may be a preferred candidate for liver-related and other pruritogenic inflammatory conditions. The molecule has a dual mechanism of action that affects both the mu and kappa opioid receptors. These extensively studied receptors, when stimulated and/or inhibited by the body s endogenous ligands, have been implicated in human itch circuitry for certain conditions, specifically cholestatic liver conditions.
Tharimmune s recently received Type C meeting feedback from the FDA confirmed the Company s plan to pursue a 505(b)(2) approval pathway for TH104, which permits inclusion of data from external studies when the active ingredient is already approved in
Based on this interaction, the Company believes it has a path forward to a Phase 2 trial with TH104 in moderate-to-severe chronic pruritus in PBC patients and is currently incorporating feedback from the FDA into its clinical protocol and anticipates initiating the trial in the latter part of 2024.
About TH104
TH104 is embedded with nalmefene onto a proprietary transmucosal buccal film that easily adheres to the inside of the mouth. This dosage form endows TH104 with key features making it an ideal product candidate for multiple liver-related and other pruritogenic inflammatory conditions. The molecule has a dual mechanism of action affecting both the -opioid and kappa opioid receptors. These opioid receptors when stimulated and/or inhibited by the body s natural ligands have been known to be involved in the body s itch circuitry.
About Tharimmune
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
Contact:
Email: ir@tharimmune.com
Email: tpatel@lhai.com
Tel: 212-201-6614
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