Tharimmune Announces Positive Results in Phase 1 Clinical Trial of TH104, its Lead Clinical Therapeutic Candidate
- Successful completion of Phase 1 clinical trial for TH104
- Positive safety and tolerability profile demonstrated with mild side effects
- Phase 2 study for chronic pruritus in PBC expected to initiate in 2024
- Company fully funded until 2025
- TH104 designed to avoid liver's first pass metabolism for liver-related conditions
- None.
Insights
The pharmacokinetic profile of TH104, including its absolute bioavailability, is a critical factor in determining the drug's potential efficacy and market viability. Transmucosal delivery systems, such as the buccal film used for TH104, are designed to enhance drug absorption and bypass hepatic first-pass metabolism, which can degrade the drug before it reaches systemic circulation. This method of delivery is particularly beneficial for drugs like nalmefene, which target conditions where the liver's function is compromised, such as primary biliary cholangitis (PBC). The dual action on mu and kappa opioid receptors suggests a targeted approach to addressing pruritus, a distressing symptom for PBC patients. It is important to note that while the safety profile is positive, the efficacy of TH104 in reducing itch intensity and improving patient quality of life will be a key factor in its adoption. The ongoing and future clinical trials will provide more data to assess this.
The financial health and strategy of Tharimmune are crucial for the continued development of TH104. With an $11 million public offering closing last quarter and funding secured into early 2025, Tharimmune appears to have a solid runway to progress through the next phases of clinical trials. The successful completion of the Phase 1 trial and the planned initiation of a Phase 2 study for TH104 in 2024 are significant milestones that could impact the company's stock valuation. Additionally, the upcoming R&D Day in the second quarter of 2024 presents an opportunity for the company to solidify investor confidence by providing updates on clinical and non-clinical programs. Investors will be closely monitoring the topline readout and full data expected in the second quarter to gauge the potential market opportunity for TH104.
The completion of the Phase 1 clinical trial with TH104 is a pivotal step for Tharimmune in demonstrating the drug's safety and tolerability. The crossover study design is an effective way to compare the oral transmucosal delivery system against the intravenous reference drug. The fact that the adverse events were mild and self-resolving is reassuring, but it is the Phase 2 trial that will provide more robust data on efficacy. As pruritus in PBC is currently under-treated and represents a significant unmet medical need, TH104 could potentially fill this gap if Phase 2 results are favorable. The attention to pruritus intensity reduction in previous studies indicates that Tharimmune is strategically targeting a key symptom of PBC, which could lead to improved patient outcomes and a competitive advantage in the market if the drug is approved.
Positive safety/tolerability profile achieved with TH104 showing self-resolving, mild side effect profile aligned with previous studies
Phase 1 clinical trial compared oral transmucosal delivery of TH104 to injectable reference approved drug completed
Company fully funded into 2025 with Phase 2 moderate-to-severe chronic pruritus in primary biliary cholangitis (PBC) study on-track and expected to initiate in 2024
BRIDGEWATER, NJ / ACCESSWIRE / February 20, 2024 / Tharimmune, Inc. (NASDAQ:THAR) ("Tharimmune" or the "Company"), a clinical-stage biotechnology company developing a portfolio of therapeutic candidates for inflammation and immunology announced today the completion of the Company's Phase 1 clinical trial with TH104. TH104 is a proprietary transmucosal buccal film embedded with the approved, active compound nalmefene which easily adheres inside of the mouth on the cheek and biodegrades within minutes. TH104, is designed to avoid the liver's first pass metabolism seen in oral formulations and may be an ideal product candidate for multiple liver-related and other pruritogenic inflammatory conditions. The molecule has a dual mechanism of action affecting both the mu and kappa opioid receptors. These well-known mu and kappa receptors, when stimulated and/or inhibited by the body's endogenous ligands, have been implicated in the body's itch circuitry for certain conditions, specifically cholestatic or dysregulated bile acid-related liver conditions.
The completed Phase 1 clinical trial was a pharmacokinetic bridging study in the U.S. and was designed as a single-dose, single-center, open-label, randomized 2-way crossover study with 16 mg of TH104 compared to an intravenous 1 mg dose of nalmefene administered under fasting conditions, with a 7-day washout period between doses. Sixteen subjects were planned and pre-specified to complete both doses of the crossover design per the study protocol. Twenty normal healthy volunteers participated, and 19 subjects completed the study. The primary objective was to evaluate the absolute bioavailability of TH104 as well as assess safety and tolerability. The Phase 1 pharmacokinetic analysis is ongoing and topline readout and full data are expected to be achieved in the second quarter of 2024.
The Phase 1 study demonstrated that TH104 had a comparable safety and tolerability profile to the FDA approved nalmefene reference intravenous formulation of the drug. In the preliminary analysis of the completed trial safety results, all adverse events reported in the clinical trial were categorized as mild and were evenly reported between TH104 and intravenous injection. One patient did not return for the second dose of the study after a 7-day washout post the first dose which was unrelated to the study. There were no deaths, serious adverse events, or other significant adverse events reported during the entire study with events consistent with the safety profile of marketed formulations as well as those described in the literature including self-resolving nausea, dizziness, and drowsiness per previous reports with nalmefene.
"We are pleased with the completion of our Phase 1 study of TH104 and our expectations for a safe and tolerable transmucosal film delivery have been met," said Randy Milby, Chief Executive Officer of Tharimmune. "We would like to thank the Trial subjects for participating in this program where the data generated are a critical step forward to continue our momentum and remain on-track to initiate a Phase 2 program this year."
Primary biliary cholangitis (PBC) is a chronic cholestatic autoimmune disease with debilitating symptoms, including pruritus or "unrelenting itching" and fatigue. Pruritus is a common clinical feature seen in liver diseases but particularly frequent in cholestatic liver disease. A recent study found that pruritus in PBC is under-treated in clinical practice in the United States. Current treatment options may only be partially effective or poorly tolerated and are not FDA-approved for cholestatic pruritus in patients with PBC, therefore effective solutions for this significant problem are a high unmet need.
Earlier, we announced data from several ex-US human studies with TH104 showing consistent and predictable delivery of nalmefene in healthy subjects using our proprietary drug embedded transmucosal buccal film. Another previously disclosed study of an open-label trial using TH104 in cholestatic liver disease patients showed a
Tharimmune announced last quarter the closing of an
About TH104
TH104 is embedded with nalmefene onto a proprietary transdermal buccal film which easily adheres to the inside of the mouth. This 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 Pruritus and Primary Biliary Cholangitis
According to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the National Institutes of Health, PBC, is a chronic disease where the bile ducts in the liver eventually become dysfunctional and cause the buildup of bile which causes liver damage. The disease, believed to be an autoimmune condition, affects an estimated 58 out of every 100,000 U.S. women and about 15 out of every 100,000 U.S. men. Pruritus is one of the most common symptoms associated with PBC affecting up to
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 is known 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 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/A for the year ended December 31, 2022 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.
Investor Relations Contact
ir@tharimmune.com
www.tharimmune.com
SOURCE: Tharimmune, Inc.
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