Tharimmune Launches New Website as Discussions with FDA Continue for Phase 2 Clinical Trial with TH104

Rhea-AI Summary

Tharimmune (NASDAQ:THAR), a clinical-stage biotech company, has launched a new website at www.tharimmune.com. The redesigned platform offers comprehensive information about the company's research, clinical trials, and corporate developments. CEO Randy Milby emphasized the website's role in enhancing communication with stakeholders.

Concurrently, Tharimmune is continuing discussions with the FDA regarding the design and initiation of a Phase 2 clinical trial for TH104, their lead candidate. The trial aims to address moderate-to-severe chronic pruritis in primary biliary cholangitis. The company expects to launch the Phase 2 trial in Q3 2024, following a productive Type C meeting with the FDA.

Positive

• Launch of new informative website to enhance stakeholder communication
• Ongoing productive discussions with FDA for Phase 2 clinical trial design
• Planned initiation of Phase 2 trial for TH104 in Q3 2024
• TH104 targets large unmet medical need in chronic pruritis

Negative

• None.

BRIDGEWATER, NJ / ACCESSWIRE / July 16, 2024 / Tharimmune, Inc. (NASDAQ:THAR) ("Tharimmune" or the "Company"), a clinical-stage biotechnology company developing a portfolio of therapeutic candidates in inflammation & immunology, announces the launch of its new website at www.tharimmune.com. This redesigned online platform provides patients, healthcare professionals and stakeholders with comprehensive information about Tharimmune's cutting-edge research, ongoing clinical trials and corporate developments.

"Our new website represents a valuable resource in our commitment to engage with the broader medical community and our investors," said Randy Milby, CEO of Tharimmune. "We believe this platform enhances our ability to communicate our mission and progress, as well as foster stronger connections with all our stakeholders."

The new website features a user-friendly interface, detailed sections on Tharimmune's pipeline of investigational therapies, including its lead candidate, TH104, and resources for patients and caregivers. Visitors will also find the latest news and updates, company-produced content, scientific publications, upcoming events and opportunities for collaboration.

In tandem with the launch of the new website and following a productive Type C meeting with the U.S. Food and Drug Administration (FDA), Tharimmune is continuing discussions with the FDA, regarding the study design and initiation of a Phase 2 clinical trial for TH104 in moderate-to-severe chronic pruritis in primary biliary cholangitis.

"These ongoing discussions have been valuable in shaping the design of the next study and are a critical step in advancing the development of our promising therapy, which has the potential to address a large unmet medical need. We expect to launch the Phase 2 trial in the third quarter of this year," added Mr. Milby.

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 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 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.

View the original press release on accesswire.com

FAQ

What is the purpose of Tharimmune's new website?

Tharimmune's new website aims to provide comprehensive information about the company's research, clinical trials, and corporate developments to patients, healthcare professionals, and stakeholders.

When does Tharimmune (THAR) expect to launch the Phase 2 trial for TH104?

Tharimmune expects to launch the Phase 2 clinical trial for TH104 in the third quarter of 2024.

What condition is Tharimmune's TH104 targeting in its upcoming Phase 2 trial?

TH104 is targeting moderate-to-severe chronic pruritis in primary biliary cholangitis in its upcoming Phase 2 clinical trial.

What is the current status of Tharimmune's (THAR) discussions with the FDA?

Tharimmune is continuing discussions with the FDA regarding the study design and initiation of a Phase 2 clinical trial for TH104, following a productive Type C meeting.