NodThera Charts Obesity Future with First Patients Dosed in Phase 2 RESOLVE-1 Trial of Oral NLRP3 Inflammasome Inhibitor NT-0796
NodThera Charts Obesity Future with First Patients Dosed in Phase 2 RESOLVE-1 Trial of Oral NLRP3 Inflammasome Inhibitor NT-0796Philadelphia, PA, June 4, 2025 - NodThera, a leading clinical-stage biotech delivering a paradigm shift in the treatment of chronic inflammatory diseases through selective modulation of the NLRP3 inflammasome, today announces that the first patients have been dosed in its Phase 2 RESOLVE-1 (RESolution Of infLammation to treat obesity and cardioVascular disEase) clinical trial investigating the potential of its lead candidate, oral NLRP3 inflammasome inhibitor NT-0796, in patients with obesity.
NodThera's pioneering approach to obesity treatment is built on the growing understanding of the impact of chronic inflammation on the body and its fundamental role in the complex cycle of weight regulation which balances calorie intake, energy expenditure and satiety. While current drugs have made significant achievements in the management of obesity, their mechanisms primarily suppress the desire to eat (calorie restriction) or they promote a feeling of fullness, ultimately reducing food intake. NodThera's approach goes beyond the reduction of food intake by resetting the body's weight regulatory system and correcting the underlying imbalance, to return the body to its natural metabolic state.
Daniel Swisher, Chief Executive Officer of NodThera, commented: 'With its novel molecular mechanism, the convenience of oral dosing without titration, and a well-tolerated safety profile, this fully brain-penetrant NLRP3 inflammasome inhibitor is projected to have a transformative impact on obesity by bringing the body back to balance. I am delighted that, following our recently closed $50 million Series D financing, we have accelerated our lead program into this robust Phase 2 trial, building on an impressive preclinical and clinical data set. This will support the progression of NT-0796 as an enhanced treatment for weight management, to enable patients to achieve sustained and healthy weight loss.'
RESOLVE-1 is a randomized, double-blind, placebo-controlled Phase 2 trial that will evaluate the efficacy and safety of NT-0796 in patients with obesity, with or without type 2 diabetes, over 24 weeks. 160 patients are expected to be randomized into three treatment groups, receiving twice daily oral NT-0796, once daily oral NT-0796 or placebo. The trial's primary endpoint is the change in body weight in participants from baseline to week 24. Secondary endpoints include the impact of NT-0796 on body composition, metabolic biomarkers, and HbA1c levels in participants with type 2 diabetes. Headline data from the study are anticipated in Q2 2026.
Returning the body to its natural metabolic balance – homeostasis Earlier preclinical and clinical work undertaken by the Company has demonstrated that NLRP3, an intracellular sensor and master switch that modulates inflammation, plays a key role in controlling obesity and obesity-associated inflammation. The fully brain-penetrant NT-0796 reduces inflammation in the brain, as well as throughout the body, to restore multiple dysregulated cardiometabolic pathways. The inhibition of NLRP3 results in the loss of fat mass, while preserving lean muscle mass, and restores the body's natural metabolic balance (homeostasis), enabling sustainable, enhanced and healthy weight loss.
Positive clinical data announced by the Company in June 2024, from a Phase 1b/2a cardiovascular risk study in patients with obesity, confirmed NT-0796's profound anti-inflammatory effect and supported its anti-obesity potential. This followed the publication of preclinical data in the Journal of Pharmacology and Experimental Therapeutics, demonstrating the potential of NT-0796 to reverse diet-induced obesity and inflammation in an animal model of the disease, matching weight loss driven by the GLP-1 receptor agonist, semaglutide. Most recently, data published in the journal Obesity showed the enhanced weight loss effect of NT-0796 when combined with semaglutide in a preclinical obesity model. The potential of NT-0796 to improve the efficacy and tolerability of existing GLP-1RA obesity therapies will be further investigated in NodThera's upcoming Phase 2 combination trial, RESOLVE-2, expected to commence in H2 2025.
Alan Watt, President and Chief Scientific Officer of NodThera, added: 'Through central NLRP3 inhibition and the correction of multiple dysregulated pathways in the brain and throughout the body, NT-0796 has the potential to deliver robust weight loss and broad cardiometabolic benefits that go beyond those seen with current therapies. NodThera's treatment approach, restoring the body's natural metabolic balance, would be game-changing.'
For more information about NodThera please contact:
NodTheraTel: +44 (0) 1223 608130Email: info@nodthera.com
ICR Healthcare Amber Fennell, David Daley Tel: +44 (0)20 3709 5700Email: nodthera@icrhealthcare.com
About NodTheraNodThera is a leading clinical-stage biotech developing brain-penetrant NLRP3 inflammasome inhibitors to treat chronic inflammatory diseases. Led by an experienced management team, NodThera is combining a deep understanding of NLRP3 inhibition, pharmaceutical neuroscience expertise and precision chemistry. Its two lead clinical candidates are oral, small molecule NLRP3 inflammasome inhibitors, which have demonstrated differentiated, potentially best-in-class clinical profiles with significant anti-inflammatory effects and high brain penetration, offering distinct opportunities to treat multiple indications. The Company is backed by top-tier investors including 5AM Ventures, Blue Owl Capital, Epidarex Capital, F-Prime Capital, Novo Holdings, Sanofi Ventures and Sofinnova Partners. NodThera is headquartered in Philadelphia, Pennsylvania, with additional operations in Cambridge, UK. Learn more at www.nodthera.com or follow the Company on LinkedIn.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
an hour ago
- Yahoo
Crypto Currents: Strategy buys more bitcoin
As bitcoin, ethereum and other cryptocurrencies get increasing attention from investors, Wall Street and its traditional banks continue to adjust to the shift. Catch up on this week's top stories highlighting the intersection of these old guard and new school areas of finance with this recap compiled by The Fly. Easily unpack a company's performance with TipRanks' new KPI Data for smart investment decisions Receive undervalued, market resilient stocks right to your inbox with TipRanks' Smart Value Newsletter STRATEGY BUYS MORE BITCOIN: Strategy (MSTR) announced updates on Monday with respect to its at-the-market offering programs and bitcoin holdings. The company purchased 705 bitcoin during the period of May 26 to June 1 at an aggregate purchase price of $75.1M. Strategy now holds 580,955 bitcoin. TRUMP MEDIA FILES REGISTRATION STATEMENT FOR BITCOIN ETF: On Thursday, Trump Media and Technology Group (DJT) announced the filing with the U.S. Securities and Exchange Commission of the initial registration statement on Form S-1 for the Truth Social Bitcoin ETF. The ETF will hold bitcoin directly and offer its shares to investors, aiming to reflect bitcoin's price performance. will act as the ETF's exclusive bitcoin custodian, prime execution agent and liquidity provider. The launch of the Truth Social Bitcoin ETF is pending effectiveness of the Registration Statement as well as approval of a Form 19b-4 filing with the SEC. Upon launch, the Shares will be listed on NYSE Arca. Yorkville America Digital acts as the sponsor of the ETF. Additionally on Thursday, Trump Media announced it has filed a registration statement on form S-3 with the U.S. Securities and Exchange Commission related to debt and equity subscription agreements recently entered into with approximately fifty investors that yielded approximately $2.3B in total proceeds. The proceeds will be used for the company's creation of a bitcoin treasury and for general corporate purposes. In accordance with registration obligations in the previously-disclosed agreements, the Registration Statement seeks to register for resale by the investors approximately 56M shares of equity and 29M shares underlying convertible notes. Additionally, having recently become form S-3 eligible, Trump Media is taking the customary step of including within the Registration Statement a universal shelf. CEO Devin Nunes said, 'These activities will provide the company with the capital, assets, independence, flexibility, and security we need to fulfill our goals of rapid expansion, guaranteeing a wide array of ways to access the capital markets when it's most advantageous to do so. We're systematically putting in place all the elements we need to grow the company according to our plans, acquire crown jewel assets, and draw more customers and users into the patriot economy.' MAWSON INFRASTRUCTURE APPOINTS INTERIM CEO: In a Thursday regulatory filing, Mawson Infrastructure Group (MIGI) reported it had provided Rahul Mewawalla with notice that termination of his employment as CEO and President of the company for 'Cause', based on conduct specified in the notice, will be considered at a future meeting of the company's Board of Directors, at which the Board will determine whether his conduct constitutes Cause sufficient to terminate Mewawalla in accordance with the terms of his employment agreement. Mewawalla's employment agreement with the company provides for a cure period, which will end on June 14. On June 2, the Board determined to place Mewawalla on administrative leave from his position as CEO and President and appointed Kaliste Saloom to serve as Interim CEO. Saloom has served as General Counsel and Corporate Secretary since July 1, 2024. HUT 8 INITIATED WITH BUY: On Thursday, Roth Capital initiated coverage of Hut 8 (HUT) with a Buy rating and $25 price target. Hut 8 is transforming into a power-first digital infrastructure platform, with 1.0GW energized, 2.6GW under exclusivity, and long-term growth visibility from bitcoin hosting and high-performance computing colocation, the analyst said. The firm added three HPC sites position the company to benefit from artificial intelligence demand, offering 60%-plus adjusted EBITDA margins. The combination of highly visible colocation agreements in bitcoin and HPC provides Hut 8 a strategic advantage, leading to margin expansion and re-rating potential with strategic execution, contended Roth. ANALYST CALLS GAMESTOP, STRATEGY VALUATION DISPARITY 'BAFFLING': On Thursday, Wedbush reiterated an Underperform rating on GameStop (GME) with a $13.50 price target after the company last week disclosed that it purchased 4,710 bitcoin, 'following the MicroStrategy playbook.' However, Strategy currently trades 1.75-times its bitcoin holdings, while GameStop trades at 2.4-times cash value, suggesting that investors value GameStop's entry into bitcoin at the same premium they assign to Strategy shares, but value GameStop's core operations at $8 per share, the analyst said. The firm added that while it is likely GameStop will convert more of its cash into bitcoin, the disparity in valuation between company and Strategy 'is baffling.' Both companies provide bitcoin investors the ability to use margin to invest in crypto, but GameStop's holdings 'are literally 1% as great as MSTR's,' according to Wedbush. The firm believes GameStop's entry into the trading card business has delivered 'modest success,' but it sees no potential for a rebound in the company's core business. OTHER CRYPTO NEWS: Bitcoin Depot (BTM) price target raised to $6 from $5 at Northland Riot Platforms (RIOT) hires Jonathan Gibbs as Chief Data Center Officer Trump's USD1 (JPM) to offer clients financing against crypto ETFs World Liberty Financial reportedly sends cease-and-desist over memecoin CRYPTO STOCK PLAYS: Publicly traded companies in the space include Bit Digital (BTBT), Coinbase (COIN), Core Scientific (CORZ), Greenidge Generation (GREE), Mara Holdings (MARA), Strategy, Riot Platforms and TeraWulf (WULF). PRICE ACTION: As of time of writing, bitcoin dropped roughly 1% this week to $104,449 in U.S. dollars, according to CoinDesk. Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See the top stocks recommended by analysts >> Read More on MSTR: Disclaimer & DisclosureReport an Issue Strategy Announces Underwriting Agreement with Barclays World Liberty Financial sends cease-and-desist over memecoin, Bloomberg reports GameStop and Strategy valuation disparity 'baffling,' says Wedbush Stablecoin Issuer Circle (CRCL) Soars 235% in Market Debut JPMorgan to offer clients financing against crypto ETFs, Bloomberg reports
New York Post
2 hours ago
- New York Post
Weight loss drugs like Ozempic could mess with your birth control — and get you pregnant
A UK watchdog is urging women on GLP-1 weight-loss drugs like Ozempic and Mounjaro to use effective forms of birth control after receiving more than 40 pregnancy-related reports linked to the medications. The warning comes as women flood social media with stories of their so-called 'Ozempic babies' — including surprise pregnancies while on the pill. Trying to shed pounds, not grow a baby bump? Here's what you need to know about GLP-1s, pregnancy and the best contraception options to stay protected. 4 Studies show that at least one in eight US adults have tried GLP-1s. íÅí°íâ¬í¸í½í° íâíµí¼íµíËí°í¾ – What's in your GLP-1? Several GLP-1 drugs dominate the market, including Ozempic and Wegovy. Both contain semaglutide, an active ingredient that mimics a natural hormone in the body that boosts insulin production, slows digestion and curbs appetite. Then there's Saxenda and Victoza, powered by liraglutide, which functions in a similar way. Newer drugs like Mounjaro and Zepbound rely on tirzepatide, a key ingredient that targets a second hormone involved in appetite and blood sugar control. A surprise side effect While gastrointestinal symptoms like nausea, vomiting and diarrhea are common with GLP-1s, the surprise side effect making waves is unexpected pregnancy. The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) has received 28 reports related to pregnancy in patients on tirzepatide, and nine each for semaglutide and liraglutide. 4 Women on tirzepatide-based GLP-1s should use barrier contraception. nenetus – In an alert this week, the agency warned that tirzepatide may reduce the effectiveness of oral contraceptives, especially in women with higher body weight. As a result, it recommended using barrier methods like condoms while on drugs like Mounjaro. So far, there's no evidence that GLP-1s affect non-oral birth control like IUDs, implants, patches, or rings, according to the UK's Faculty of Reproductive Healthcare. And yes, the advice applies even to women previously told they were infertile. GLP-1s have been shown to boost fertility by aiding weight loss, reducing inflammation and improving insulin sensitivity — leading some to conceive just months after starting treatment. 4 GLP-1 agonists can increase your fertility, but they can also interfere with pregnancy. Louis-Photo – Can you take GLP-1s while pregnant? Experts say no — at least not yet. There's not enough data to confirm whether GLP-1s are safe during pregnancy. While a some human studies suggests there is no harm in first-trimester use, testing in animals has shown the drugs could increase the risk of miscarriage and birth defects. 4 Scientists are still working to understand whether GLP-1s can negatively impact a developing fetus. Evrymmnt – Another reason to skip GLP-1s while pregnant: they suppress your appetite and can trigger gastrointestinal issues, which may lead to nutrient deficiencies that impact fetal development. The drugs should also be avoided during breastfeeding, since there's not enough research to confirm safety for infants. Trying to conceive? Here's the timeline If you're planning to get pregnant, the MHRA recommended stopping GLP-1s before you start trying to conceive and giving your body time to clear the drugs. For semaglutide users, that means quitting at least two months ahead. If you're on tirzepatide, stop one month before trying. Liraglutide clears the system faster, so you can stop right before you start trying to conceive.
Yahoo
2 hours ago
- Yahoo
Fact Check: What we know about 'Big Beautiful Bill' banning states from regulating AI for 10 years
Claim: H.R. 1, commonly known as the One Big Beautiful Bill Act, contains a provision that bans states from regulating artificial intelligence for 10 years. Rating: Context: If the "Big Beautiful Bill" becomes law, states and local governments would be unable to enforce any regulations on AI systems and models involved in interstate commerce for 10 years. There are exceptions for any laws or regulations that facilitate the rollout, operations or adoption of AI models and systems. A budget bill that Republicans in the U.S. House of Representatives passed on May 22, 2025, allegedly bans all 50 states from regulating artificial intelligence for a decade, according to claims shared on social media in early June. As the Senate prepared to take up H.R. 1, more commonly known as the One Big Beautiful Bill Act, people online expressed their concerns about the alleged AI-related provisions in the legislation. For example, one X user shared this claim (archived) on June 2, 2025: Similar claims also appeared in Facebook (archived) posts (archived) around the same time. Snopes reviewed the text of H.R. 1 and found a provision that bans states from regulating AI systems "entered into interstate commerce" for 10 years in Section 43201 of the bill. Paragraph (c) in that section outlines the 10-year moratorium on states' AI regulation: (1) In general. – Except as provided in paragraph (2), no State or political subdivision thereof may enforce, during the 10-year period beginning on the date of the enactment of this Act, any law or regulation of that State or a political subdivision thereof limiting, restricting, or otherwise regulating artificial intelligence models, artificial intelligence systems, or automated decision systems entered into interstate commerce. In other words, if the bill becomes law, states and local governments will be blocked from enforcing any regulations on AI systems and models that are involved in interstate commerce for 10 years. The phrase "interstate commerce" broadly refers to business or activity that crosses state lines. But in the context of this bill, the distinction likely doesn't mean much. As a result, we've rated the claim mostly true. The Supreme Court has said activities that happen entirely within one state can still count as interstate commerce if they have a significant enough impact on the national economy, as David Brody, a civil rights and technology legal expert, explained in an article for Tech Policy Press published on May 27, 2025. That means many AI systems would likely be subject to the federal rules if H.R. 1 passes. However, there are some exceptions to the 10-year moratorium on states' AI regulation — notably for any laws or regulations that facilitate the rollout, operations or adoption of AI models and systems, according to the bill text. Snopes reached out to the White House and the office of U.S. Rep. Jodey Arrington, R-Texas, who introduced H.R. 1, for comment about the 10-year moratorium on states regulating AI and the purpose of including it in the bill, and is awaiting responses. Multiple Republican lawmakers have voiced support for the 10-year moratorium, with some saying a patchwork of state laws doesn't support innovation and others stressing the importance of a federal approach to AI regulation. But other federal and state lawmakers as well as watchdog groups have strongly opposed the proposed rule over concerns about limiting states' ability to deal with potential harms caused by AI. For example, U.S. Rep. Marjorie Taylor Greene, R-Ga., said in an X post on June 3, 2025, that she "did not know about" the section of H.R. 1 that bans states from regulating AI for a decade, adding that she is "adamantly opposed" to the provision. Hundreds of state lawmakers across the political spectrum also signed a letter addressed to the U.S. House and Senate on June 3, 2025, expressing "strong opposition" to the 10-year moratorium on AI regulation. The letter read in part, "The proposed 10-year freeze of state and local regulation of AI and automated decision systems would cut short democratic discussion of AI policy in the states with a sweeping moratorium that threatens to halt a broad array of laws and restrict policymakers from responding to emerging issues." Nearly two weeks earlier, a coalition of advocacy organizations, including Common Sense Media, Fairplay and Encode, also called on congressional leaders to oppose the provision, writing in part that AI companies would have "no rules, no accountability and total control" if it were to take effect. In a letter dated May 21, 2025, the groups wrote: As written, the provision is so broad it would block states from enacting any AI-related legislation, including bills addressing hyper-sexualized AI companions, social media recommendation algorithms, protections for whistleblowers, and more. It ties lawmakers' hands for a decade, sidelining policymakers and leaving families on their own as they face risks and harms that emerge with this fast-evolving technology in the years to come. Discussions about AI companions and possible issues arising from their use have gained prominence in recent months. For example, research from Drexel University in Philadelphia suggests that inappropriate behavior, including sexual harassment, during conversations with AI chatbots is "becoming a widespread problem," the university said on May 5, 2025. Consumer Reports, another advocacy organization, also raised concerns about states being unable to deal with a variety of issues that AI technology poses, including sexually explicit images, audio and video created without a person's consent. Snopes has previously looked into other claims about the "Big Beautiful Bill," including whether it contains a provision allowing the U.S. president to delay or cancel elections. Arrington, Jodey. "Text - H.R.1 - 119th Congress (2025-2026): One Big Beautiful Bill Act." 2025, Accessed 4 June 2025. Brody, David. "The Big Beautiful Bill Could Decimate Legal Accountability for Tech and Anything Tech Touches." Tech Policy Press, 27 May 2025, Accessed 4 June 2025. Cornell Law School. "Commerce Clause." Legal Information Institute, 18 Sept. 2018, Accessed 4 June 2025. Hendrix, Justin. "Transcript: US House Subcommittee Hosts Hearing on 'AI Regulation and the Future of US Leadership.'" Tech Policy Press, 21 May 2025, Accessed 4 June 2025. Open letter from consumer advocacy organizations to congressional leadership. Common Sense Media, 21 May 2025, Accessed 4 June 2025.
