Tharimmune Presents Positive Clinical Data Highlighting TH104 Metabolic Profile and Advances Program for Prophylaxis Against Ultrapotent Opioid Exposure Following FDA Feedback
Press Releases Tharimmune Presents Positive Clinical Data Highlighting TH104 Metabolic Profile and Advances Program for Prophylaxis Against Ultrapotent Opioid Exposure Following FDA Feedback
Tharimmune, Inc., (Nasdaq:THAR) ("Tharimmune" or the "Company") a clinical-stage biopharmaceutical company focused on developing innovative therapeutics in inflammation & immunology released pharmacokinetic and metabolism data from its Phase 1 study of TH104, a buccal film formulation of nalmefene, in healthy subjects. Tharimmune recently highlighted the advancement of TH104 for the proposed indication of temporary prophylaxis against respiratory and/or central nervous system depression in military personnel and chemical incident responders exposed to high-potency opioids, following recent positive feedback from the U.S. Food and Drug Administration (FDA).
The Phase 1 study presented this week at Digestive Disease Week taking place in San Diego, California evaluated the pharmacokinetics and metabolism of a single dose of TH104 (16 mg buccal film) compared to an intravenous (IV) dose of nalmefene injection (1 mg) in healthy volunteers. The study successfully demonstrated that buccal administration of TH104 achieves systemic exposure to nalmefene while offering a distinct metabolic profile compared to IV administration.
Phases of drug metabolism (such as phase 1 and phase 2) denote the "breaking down" and "tagging" of drugs, generally into molecules known as metabolites, by the liver to prepare them for removal. The key difference with drugs taken by mouth is the "first-pass effect," where the drug goes through the liver's processing immediately after being absorbed from the gut, before the drug circulates throughout the body. Drugs injected into the bloodstream bypass this initial liver processing generally leading to more drug circulating in the body before being metabolized.
Key findings from the pharmacokinetic study presented at the Digestive Disease Week 2025 included:
Buccal administration of TH104 resulted in slower absorption compared to IV administration
The ratio of the area under the curve (AUC) of nalmefene glucuronide, a metabolite, compared to nalmefene was significantly higher for TH104 versus IV administration
Pharmacokinetics of nalmefene sulfate and nornalmefene, 2 other metabolites, were significantly delayed with TH104 compared to IV administration
Both formulations showed early phase 2 metabolism (glucuronidation), but importantly, TH104 demonstrated delayed phase 1 metabolism, which is mainly catalyzed by enzymes such as cytochrome P450 oxidases in the liver
By attenuating the burden on hepatic metabolic pathways, TH104 may represent a novel therapeutic candidate for individuals with impaired liver function. The altered pharmacokinetic profile, particularly the delayed onset of phase 1 metabolism observed with buccal administration may confer a potential advantage in populations with impaired hepatic function, and may be important in patients with primary biliary cholangitis (PBC). PBC is a rare cholestatic liver disease frequently associated with intractable pruritus. Tharimmune is also advancing TH104 as a therapeutic agent for the management of moderate-to-severe chronic pruritus in PBC patients.
"The compelling pharmacokinetic data from our Phase 1 study not only supports the continued development of TH104 for symptomatic pruritus in liver disease by highlighting a potentially liver-friendly metabolic profile but importantly provides a crucial foundation for our accelerated development pathway in the opioid prophylaxis setting," said Randy Milby, CEO of Tharimmune. "The positive feedback from the FDA, namely a 505(b)(2) submission without the need for additional clinical trials for the prophylaxis indication is a transformative milestone for Tharimmune and positions TH104 as our lead program to address a critical unmet need for military personnel and first responders facing the threat of high-potency opioid exposure."
The Phase 1 results in healthy subjects also demonstrated comparable safety and tolerability between TH104 and IV nalmefene, with only mild adverse events reported. Building on the favorable pharmacokinetic and safety profile, Tharimmune is advancing TH104 as a critical medical countermeasure product. Following positive feedback from the FDA, Tharimmune is pursuing a 505(b)(2) regulatory pathway for TH104 for the temporary prophylaxis of respiratory and/or CNS depression in military personnel and chemical incident responders who may encounter environments contaminated with high-potency opioids, including weaponized fentanyl and its analogues.
The FDA has indicated that no additional clinical trials appear to be necessary prior to the submission of a New Drug Application (NDA) for this indication, allowing Tharimmune to leverage existing safety and efficacy data for nalmefene along with the pharmacokinetic data generated with the TH104 buccal film. This expedited pathway underscores the urgent need for such a prophylactic solution, particularly for chemical incident responders operating in high-risk environments where exposure to highly potent opioids is a potential threat to national security. The buccal film formulation offers a distinct advantage for rapid and convenient administration, even when personnel are wearing protective gear.
About Tharimmune, Inc.
Tharimmune is a clinical-stage biotechnology company developing a diverse portfolio of therapeutic candidates in immunology, inflammation and oncology. Its lead clinical asset, TH104, is being developed for a specific indication via a 505(b)2 pathway for respiratory and/or nervous system depression in military personnel and chemical incident responders who may encounter environments contaminated with high-potency opioids. The expanded pipeline includes other indications for TH104, such as chronic pruritus in primary biliary cholangitis and TH023, a new approach to treating autoimmune diseases along with an early-stage multispecific biologic platform targeting unique epitopes against multiple solid tumors through its proprietary EpiClick™ Technology. The Company has a license agreement with OmniAb, Inc. to access their antibody discovery technology for targeting specified disease markers. Tharimmune continues to position itself as a leader in patient-centered innovation while working to deliver long-term value for shareholders. For more information, 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, 2024 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
Alliance Advisors IR
Tirth T. Patel
tpatel@allianceadvisors.com
212-201-6614
SOURCE: Tharimmune Inc.
This story was originally published May 6, 2025 at 8:06 AM.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Business Wire
2 hours ago
- Business Wire
Emulate Launches AVA™ Emulation System to Accelerate Drug Development With First-of-its-Kind High-Throughput Organ-Chip Platform
BOSTON--(BUSINESS WIRE)--Emulate, Inc., the world leader in Organ-on-a-Chip technology, today announced the commercial launch of the AVA™ Emulation System, a self-contained instrument that cultures, incubates, and images up to 96 independent Organ-Chip samples in a single run. AVA delivers an unprecedented magnitude of in vivo -level insights faster than animal models while cutting consumable costs four-fold and in-lab labor by half compared to current generation technologies. These transformative capabilities give the pharmaceutical industry the practical means to pivot beyond animal testing and into truly human-relevant territory. With the FDA targeting animal studies to become 'the exception rather than the norm,' the need for proven human models is urgent. Emulate's Liver-Chip S1—the first and only Organ-Chip admitted to the FDA's ISTAND program. Share 'AVA gives scientists unprecedented experimental capacity with the biological depth of live human tissue—something no other platform can match,' said Jim Corbett, Chief Executive Officer at Emulate. 'By combining Emulate's proven Organ-on-a-Chip technology with high-throughput consumables, automated imaging, and streamlined workflows in one benchtop unit, AVA lets teams ask bigger questions earlier and move the right drug candidates forward faster.' AVA Emulation System: Three Instruments in One AVA is the first self-contained Organ-on-a-Chip workstation to fuse high-throughput microfluidic tissue culture, full environmental control, and real-time imaging into a single, compact benchtop unit. Key performance gains include: Expanded experimental power – 96 independent Organ-Chip samples in a single run enable researchers to achieve microplate-level scale of their Organ-Chip experiments, enabling side-by-side comparison of dozens of compounds, doses, or stimuli. Lower operating costs – AVA achieves a four-fold drop in consumable spend and up to 50% fewer cells and media per sample compared to previous generation technology. Time & labor savings – Hands-on, in-lab time is reduced by more than half, thanks to automated microscopy, remote monitoring, and the revolutionary new Chip-Array™ consumable that integrates 12 independent Organ-Chips into an SBS format for streamlined workflows with multichannel pipettes and automated liquid handlers. AI-ready datasets – A typical 7-day experiment can generate >30,000 time-stamped data points from daily imaging and effluent assays, with post-takedown omics pushing the total into the millions—providing a rich, multi-modal foundation to feed machine-learning pipelines for target discovery, lead optimization, and safety prediction. A Timely Answer to Shifting Regulations With the FDA targeting animal studies to become 'the exception rather than the norm,' the need for proven human models is urgent. Emulate's Liver-Chip S1—the first and only Organ-Chip admitted to the FDA's ISTAND program—has already outperformed animals, showing 87% sensitivity and 100% specificity for drug-induced liver injury in a 2022 Communications Medicine study. AVA now scales that level of human relevance across discovery, efficacy, and toxicology screens, accelerating safer therapies through the pipeline. 'Moving towards reduction and in some cases replacement of animal models demands both biological fidelity and throughput,' noted Dr. Lorna Ewart, Emulate Chief Scientific Officer. 'AVA meets those dual requirements, empowering teams to rank-order lead candidates, pinpoint off-target toxicities, and advance safer therapies with unprecedented speed and confidence.' Broad Impact Across Industries In biopharma, this type of reduction and replacement is already a reality. A leading pharmaceutical company has demonstrated the power of implementing Organ-Chips into their development pipeline when one of their scientists saved millions of dollars and years of development time by using Emulate Liver-Chips ahead of non-human primates to screen lipid-nanoparticle (LNP) candidates. AVA's leap in throughput of predictive human biology stands to benefit not only biopharma but a wide spectrum of sectors that currently rely on inaccurate animal testing. Large pharmaceutical pipelines can now run comparable screens in a single AVA experiment, while smaller biotech teams gain enterprise-level capacity without adding headcount or infrastructure. Beyond therapeutics, contract research organizations, consumer-product companies, and environmental agencies can harness AVA to evaluate industrial chemicals, food additives, and cosmetic ingredients under human-relevant conditions—bringing faster, more ethical safety and efficacy decisions to market-driven and regulatory programs alike. Availability Global orders are open immediately. For pricing or demonstrations, please submit a request here. About Emulate Emulate, Inc. is the pioneer of Organ-on-a-Chip technology, enabling researchers to accurately replicate human tissue function and disease biology through next generation in vitro models. From target discovery to IND submission, Emulate aims to ignite a new era in human health research—one that reduces animal testing, cuts drug development costs, and accelerates the delivery of life-saving treatments. Emulate's Organ-Chip platforms, consumables, and organ models help the world's leading pharmaceutical, biotech, and academic teams generate human-relevant data that advance safer, more effective therapies. Learn more at
Yahoo
5 hours ago
- Yahoo
Nevada health bill advances to Gov. Lombardo's desk
LAS VEGAS (KLAS) – Health bill SB 217 advanced in the Nevada legislature last week and is now on Governor Lombardo's desk awaiting his signature. The bill includes coverage for treatments like IVF, as well as fertility preservation for those who have been diagnosed with extreme illness. 'I had arthritis for most of my life. That drug that I was on, while helpful to my arthritis, was severely damaging to my egg reserves,' shared Stephanie Capellas-Glascock, who has been struggling with her infertility journey for years. 'I knew that it wasn't going to be something that I could accomplish on my own, so therefore I needed to look into fertility treatments for myself,' she explained. If signed, Nevada could become the first state in the nation to offer fertility coverage for Medicaid. However, the bill does face pushback for its cost and certain language in it. 'One of my concerns, just looking at it, so I may reserve my right to change my vote, is just the financial impact on our public employee benefit program that can go down to increasing premiums,' said Democratic Assembly Member Shea Backus, who did vote in favor. Meanwhile, the Nevada GOP party called on the governor to veto the bill. Their website cited their opposition because it 'declares embryos prior to implantation as non-human.' 'I don't think fertility treatments are a political issue. I think it's a health and medical issue,' Capellas-Glascock responded when asked about the opposition. 'We know that the GOP has some thoughts and feelings on that too, but I think the tremendous thing about IVF is that it is a miracle in medicine and science that really affords individuals the option to have a family, so when they're ready to start a family, they have that option.' When asked about the fiscal implications, she responded, 'There's always a cost associated. I think it's knowing that the pros supremely outweigh the cons.' The state estimated the cost would be about $38 million over the next two years. Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
Yahoo
5 hours ago
- Yahoo
Health New England to replace Humira coverage with lower-cost biosimilars
SPRINGFIELD, Mass. (WWLP) – Health New England announced Monday that it will shift coverage of the biologic drug Humira to more affordable FDA-approved biosimilars starting next month for members of its commercial health plans. Markey playing defense against GOP clean energy plans Effective July 1, the not-for-profit health insurer will cover Amjevita by Nuvaila and Hadlima instead of Humira, as part of a broader effort to manage rising health care costs while maintaining access to effective treatments. Humira is used to treat several chronic inflammatory conditions, including rheumatoid arthritis, Crohn's disease, and plaque psoriasis. 'Biologic medications like Humira are complex treatments that carry significant cost. Its biosimilars provide a meaningful opportunity to enhance affordability for the health care ecosystem while members continue to get the full benefits of the medication,' said Gary Tereso, PharmD, Director of Pharmacy Services at Health New England. Biologic drugs are made from living organisms and are typically more expensive than other medications. Biosimilars are developed to be nearly identical in safety, potency, and efficacy to the original biologic, but at a significantly lower cost. The shift in coverage is intended to make treatment more accessible and financially sustainable for members and employer groups alike. Health New England is directly reaching out to members who are currently prescribed Humira, along with their health care providers and pharmacies, to assist with the transition. The company said it will continue monitoring the biosimilar marketplace to ensure members receive both high-quality care and cost-effective treatment options. WWLP-22News, an NBC affiliate, began broadcasting in March 1953 to provide local news, network, syndicated, and local programming to western Massachusetts. Watch the 22News Digital Edition weekdays at 4 p.m. on Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
