Tharimmune Announces Dosing of First Patient in Phase 1 Clinical Trial of TH104, its Lead Candidate for Pruritus in Primary Biliary Cholangitis
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Insights
The initiation of a Phase 1 clinical trial and the dosing of the first patient with TH104 is a critical step for Tharimmune, Inc. in its clinical development pathway. This trial's primary endpoint, assessing the safety, tolerability and bioavailability of TH104, is fundamental for determining the viability of progressing to later-stage trials. The unique delivery mechanism of TH104, a transmucosal buccal film, aims to bypass first-pass metabolism, which could potentially offer a more direct and efficient method of delivering nalmefene to patients. This could lead to improved outcomes for patients with pruritogenic inflammatory conditions, such as primary biliary cholangitis (PBC), where pruritus is a significant symptom.
From a medical research perspective, the dual mechanism of action of TH104, targeting both mu and kappa opioid receptors and potentially inhibiting interleukin-17, is noteworthy. This combination could offer a more comprehensive approach to treating pruritus associated with liver diseases. The reported 33.3% decline in itch intensity from a previous open-label trial suggests a promising therapeutic effect, although these results will need to be confirmed in larger, controlled studies. The safety profile of nalmefene, the active ingredient, is already established, which may streamline the development process for TH104.
The market implications of Tharimmune's announcement are significant, particularly given the unmet need for effective treatments for pruritus in PBC. Pruritus is a debilitating symptom that is often under-treated and current therapies are either not fully effective or not well-tolerated. Tharimmune's TH104, if successful, could capture a substantial share of this niche market. The company's financial position, with funding into 2025, provides a stable runway to complete both Phase 1 and 2 trials, which is reassuring for investors and stakeholders. The anticipated R&D Day in 2Q24 will be an important event for the company to showcase its progress and future plans, potentially influencing investor sentiment and stock valuation.
Moreover, the proprietary nature of the oral thin film delivery system could provide Tharimmune with a competitive edge, both in terms of patent protection and differentiation from other treatments. The market for liver disease treatments, particularly those that address symptoms like pruritus, is currently underserved and TH104's progress will be closely monitored by investors interested in the biotechnology sector.
Tharimmune's strategic financial planning, demonstrated by the closing of an $11 million public offering, positions the company well to pursue its clinical development goals without immediate funding concerns. This financial buffer is crucial as clinical trials are costly and the timeline to market can be lengthy and unpredictable. Investors will be interested in the potential return on investment, which relies on the successful progression of TH104 through clinical trials and eventual market approval. The company's clear communication about its cash runway and milestones, including the expected completion dates for Phase 1 and 2 trials, provides transparency that is critical for investor confidence.
It is important to note that while the company is fully funded into 2025, the biotech industry is volatile and any setbacks in the trial could impact the company's financial position. Investors will need to weigh the risks associated with clinical development against the potential for high returns in a market with a strong unmet medical need.
Phase 1 clinical trial dosing of first patient complete; primary objective to assess safety/tolerability and absolute bioavailability of TH104
Phase 1 study expected to be completed in 1Q24 with topline readout in 2Q24
Company fully funded into 2025 with full readouts of Phase 1 and 2 in moderate-to-severe chronic pruritus in PBC expected in 4Q24/1Q25
BRIDGEWATER, NJ / ACCESSWIRE / February 5, 2024 / Tharimmune, Inc. (NASDAQ:THAR) ("Tharimmune" or the "Company"), a clinical-stage biotechnology company developing a portfolio of therapeutic candidates in inflammation & immunology announced today the first patient dosed in the Company's Phase 1 clinical trial with TH104, utilizing a proprietary oral thin film. TH104 is a proprietary transmucosal buccal film embedded with the approved, active compound nalmefene onto a thin film which easily adheres inside of the mouth on the cheek and biodegrades within minutes.
Tharimmune's lead clinical-stage asset, TH104, is designed as an ideal product candidate for multiple liver-related and other pruritogenic inflammatory conditions, by avoiding the first-pass metabolism usually in traditional oral formulations. The molecule has a dual mechanism of action affecting both the mu and kappa opioid receptors, while emerging data suggests inhibition of interleukin-17, a pro-inflammatory cytokine. The 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 Phase 1 clinical trial currently recruiting is a pharmacokinetic bridging study in the U.S. designed as a single-dose, single-center, open-label, randomized 2-way crossover study of TH104 and an intravenous dose of nalmefene administered under fasting conditions, with a 7-day washout period between doses. Sixteen normal healthy volunteers are anticipated to participate and complete the study. The primary objective is to evaluate the absolute bioavailability of TH104 as well as assess safety and tolerability. Topline data is expected in 2Q24 with a full data readout shortly thereafter.
"The dosing of the first patient in our Phase 1 study of TH104 marks the initiation of our vision of becoming a patient-focused clinical development organization," said Randy Milby, Chief Executive Officer of Tharimmune. "Along with the recently disclosed human studies conducted outside the US, and a focused effort to complete this ongoing trial, we are dedicated to advance TH104, which has the potential to bring meaningful patient benefit. We aim to continue our momentum in the clinic 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.
Multiple ex-US human studies have been completed with TH104 which showed reliable and predictable delivery of nalmefene in healthy subjects using our proprietary drug embedded transmucosal oral film applied to the inside of the cheek. Another previously disclosed study of an open-label trial using TH104 in chronic liver disease patients showed a
The Company previously announced 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 receptor and the kappa opioid receptor as well as inhibiting IL-17 inflammatory cytokine expression. 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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