Latest news with #DigestiveDiseaseWeek2025
The Hill
06-05-2025
- Health
- The Hill
Celiac sufferers can safely kiss bread-eaters, study says
People with celiac disease can safely kiss their partners who have just ingested gluten, according to the results of a new study — though researchers recommend drinking some water first. The analysis, whose findings were presented Monday at Digestive Disease Week 2025, sought to answer a question that its authors say is frequently asked but minimally researched. 'Everyone worries about whether gluten is getting into their food at a restaurant, but no one really looked at what happens when you kiss afterwards,' said Anne Lee, a Columbia University assistant professor of nutritional medicine who presented the data. 'The [previous] advice we gave about kissing and celiac disease was based on precaution and assumptions,' Lee added in the statement. 'We were using our best judgment. I felt it was important to do research to see if there was any actual risk.' Celiac disease is an autoimmune disorder that affects approximately 1 percent of the population, triggered by the consumption of gluten found in bread, pasta, soy sauce and other foods. Symptoms vary, but they can include gastrointestinal issues such as indigestion, abdominal pain and diarrhea, as well as some non-digestive symptoms including fatigue, joint pain and neurological issues. The disease can also cause long-term damage to intestines without resulting in immediate symptoms. The study looked at 10 couples that each included one individual with celiac and one without. In the first part of the study, the person without celiac had 10 saltine crackers, waited five minutes, then kissed their partner for anywhere from 10 seconds to a minute. In part two, the person repeated those steps, but drank 4 ounces of water instead of simply waiting before smooching. Researchers measured the results through surveys, urine and saliva tests of the partner with celiac to detect for the presence of gluten. In both parts, the majority of couples reported the gluten found in the saliva of the individual with celiac disease was under the maximum level allowed for food products to be marked gluten free and considered safe: 20 parts per million. In the first part of the survey — without any water — two individuals reported gluten above that threshold, one of whose urine test also came back positive, but no symptoms were reported in the surveys. When participants drank 4 ounces of water before the kiss, all participants reported gluten levels under 20 ppm. 'For clinicians, we can now say to patients, 'You don't have to go to extreme measures,'' Lee said. 'Patients with celiac disease can be more relaxed, knowing that the risk of gluten cross-contact through kissing a partner who has consumed gluten can be brought down to safe levels if food is followed by a small glass of water,' she added.
Miami Herald
06-05-2025
- Health
- Miami Herald
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: 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@ Alliance Advisors IR Tirth T. Patel tpatel@ 212-201-6614 SOURCE: Tharimmune Inc. This story was originally published May 6, 2025 at 8:06 AM.
The Guardian
05-05-2025
- Health
- The Guardian
People with coeliac disease should not fear kissing gluten-eaters, say scientists
People with coeliac disease can kiss gluten-eaters without concerns for their health, researchers have said after finding only trivial amounts of the protein are transferred during a french kiss. About 1% of people around the world are thought to have coeliac disease, an autoimmune condition triggered by gluten, although many do not have a clinical diagnosis. While the condition can be managed by avoiding gluten-containing food and drink, vigilance is also required to prevent incidental intake. Dr Anne Lee, an assistant professor of nutritional medicine at Columbia University, said her previous research revealed such concerns could take a toll on quality of life, particularly around social interactions. 'There was a real hesitancy for individuals with coeliac disease to kiss their partner,' she said, adding some even reported taking a toothbrush and mouthwash for their date to use first. Research by Lee and her colleagues suggests people with coeliac disease can kiss goodbye to such anxieties. 'If you're out and your date or your partner is having a gluten-containing meal, [they can] have a swig of something to drink, and we know that you're going to be fine,' she said. The research, which has not yet been peer-reviewed but is to be presented at Digestive Disease Week 2025 in San Diego this week, involved 10 couples, each of whom included one partner with coeliac disease and one without. In two experiments carried out on different days, the team asked those without coeliac disease to eat 10 crackers containing gluten each, before either waiting for five minutes or immediately drinking 120ml of water and then kissing their partner for at least one minute with tongues. Immediately after each kiss, the saliva of the partner with coeliac disease was tested. The results reveal only two of the 20 kisses resulted in the partner with coeliac disease having a gluten concentration in their saliva above the 20ppm threshold that is acceptable for 'gluten-free' products. Neither of these kisses occurred after water was consumed, and only one was associated with a positive urine test for gluten the same evening. What's more, none of those with coeliac disease reported experiencing any symptoms in the six or 12 hours after a kiss. However, the team found the saliva of the cracker-consuming, non-coeliac participants had a gluten content far above the 20ppm threshold after eating, whether they were tested five minutes, 10 minutes or 30 minutes afterwards, or consumed 120ml of water before testing. David Sanders, a professor of gastroenterology at the University of Sheffield – who was not involved in the work – said that while the study was very small, the results should reassure people with coeliac disease. 'I admire the investigators for trying to take a scientific approach to something which has been a cause for concern within the coeliac community,' he said. Dr Mahima Swamy, of the University of Dundee, agreed, although she noted gluten sensitivity varied among people with coeliac disease, meaning those who are very sensitive may have be more cautious. 'If you [have] symptoms despite following these guidelines, then it may be that you [are] much more sensitive,' she said.
