Tharimmune Announces Positive Type C Meeting with FDA for Phase 2 Program for TH104, its Lead Candidate for Moderate-to-Severe Pruritus in Primary Biliary Cholangitis
Tharimmune has received positive feedback from the FDA for its Phase 2 clinical trial of TH104, a transmucosal buccal film containing nalmefene, for treating moderate-to-severe pruritus in primary biliary cholangitis (PBC). This feedback supports Tharimmune's plan to pursue a 505(b)(2) approval pathway, allowing the use of existing data on the approved active ingredient. The FDA acknowledged that the nonclinical studies are adequate for Phase 2 trial initiation and provided recommendations on study design, patient inclusion, primary endpoints, and monitoring for adverse events. Tharimmune aims to start the trial in late 2024.
- Positive FDA feedback supports Phase 2 trial initiation.
- FDA supports 505(b)(2) pathway, allowing use of existing data on nalmefene.
- Nonclinical studies deemed sufficient for Phase 2 by FDA.
- FDA provided detailed recommendations on study design and patient monitoring.
- Company plans to start the Phase 2 trial in late 2024.
- No specific negative points were directly highlighted in the PR.
Insights
The positive feedback from the FDA regarding Tharimmune's Phase 2 clinical trial for TH104 is a notable development in the field of clinical research, particularly for those impacted by Primary Biliary Cholangitis (PBC). This feedback suggests that the FDA sees potential in TH104's approach, which uses a novel buccal delivery system to bypass liver metabolism. This method could provide more effective symptom management for PBC patients who suffer from moderate-to-severe pruritus, a debilitating condition with limited treatment options.
Additionally, the choice to pursue a 505(b)(2) approval pathway can potentially expedite the approval process by leveraging existing data on the active ingredient, nalmefene. This can save significant time and resources, making it a strategic move for Tharimmune. However, the company will still need to demonstrate the safety and efficacy of TH104 in its specific formulation and delivery method, which requires careful consideration during the upcoming Phase 2 trial.
For retail investors, it’s important to understand that while this FDA feedback is a positive step, it’s still an early stage in the drug development process. Results from the Phase 2 trial, expected to start later this year, will be important in determining the viability of TH104 as a treatment option. Success in this trial could lead to significant advancements in treating PBC-related pruritus and potentially broader applications in other inflammatory conditions.
From a financial perspective, the FDA’s endorsement of Tharimmune’s proposed Phase 2 trial design and their acceptance of the 505(b)(2) approval pathway can be seen as positive indicators. This pathway can significantly reduce the cost and timeline for drug development as it allows the company to use existing clinical data on nalmefene. This can lead to quicker market entry and potentially earlier revenue generation, which is favorable for investors.
Furthermore, the confirmation of the nonclinical studies being sufficient to support the Phase 2 trial reduces immediate additional R&D expenditure, which helps in conserving cash reserves. Investors should note that Tharimmune's ability to start the Phase 2 trial in the latter part of 2024, contingent on incorporating FDA feedback, suggests a well-structured developmental timeline. This bodes well for the company’s financial health in the near term, as it avoids delays that could impact funding and operational efficiency.
However, investors should remain cautious about the typical risks associated with clinical trials, including potential adverse events and the eventual outcomes of the study. While the FDA’s feedback is promising, the financial implications will heavily depend on the successful execution and results of the Phase 2 trial.
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
BRIDGEWATER, NJ / ACCESSWIRE / June 17, 2024 / 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. 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, 2023 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.
ir@tharimmune.com
LHA Investor Relations
Tirth T. Patel
tpatel@lhai.com
212-201-6614
SOURCE: Tharimmune, Inc.
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FAQ
What is TH104 and its purpose?
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