FDA Provides Positive Feedback to Company Regarding TH104 Phase 2 Program
Company Incorporating FDA Feedback into Phase 2 Protocol
Company Believes it is On-track to Initiate Phase 2 Trial
Tharimmune, Inc. (Nasdaq:THAR) ("Tharimmune" or the "Company"), a clinical-stage biotechnology company developing a portfolio of therapeutic candidates for inflammation and immunology, reports positive Type C meeting feedback from the U.S. Food and Drug Administration (FDA) for its Phase 2 clinical trial with TH104, a proprietary transmucosal buccal film embedded with the approved, active compound nalmefene for moderate-to-severe pruritus or "uncontrolled itching" in primary biliary cholangitis (PBC), a rare form of liver disease with no known cure.
"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 Randy Milby, Chief Executive Officer of Tharimmune.
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 (μ-) 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 the United States. The FDA also agreed that the nonclinical studies submitted to the FDA in advance of the meeting appear sufficient to support the proposed Phase 2 clinical trial. In addition, the FDA provided feedback on study design and certain recommendations regarding PBC patient inclusion, the primary endpoint to assess pruritus in these patients, and considerations for monitoring for adverse events in this patient population.
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 µ-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
Tharimmune, Inc. is a clinical-stage biotechnology company developing a portfolio of therapeutic candidates for inflammation and immunology. The Company's lead clinical-stage asset, TH104, has been observed to suppress chronic, debilitating pruritus or "uncontrollable itching" in PBC, a rare and orphan liver disease with no known cure. The Company's early-stage immunology pipeline includes novel multi-specific antibodies targeting unique epitopes with novel mechanisms of action against well-known, validated targets in multiple solid tumors, including PD-1, HER2 and HER3. Tharimmune has a license agreement with OmniAb, Inc. to access the company's antibody discovery technology platform against these and other specified targets.
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