Latest news with #hidradenitissuppurativa
Medscape
2 days ago
- Health
- Medscape
Pediatric HS Linked to Gut Microbiome Changes
Emerging evidence suggests the gut microbiome may play a contributing role in the development of inflammatory skin diseases — including hidradenitis suppurativa (HS). The evidence incudes a small prospective study recently published in JAMA Dermatology , which found significant differences in gut microbial composition in pediatric patients with HS compared with matched healthy control participants, offering new insights into possible disease mechanisms that may extend beyond the skin. This follow-up to prior microbiome studies included pediatric participants for the first time. 'Overall, we found significant differences in gut microbiome composition of pediatric patients with HS compared with pediatric control participants and adult patients with HS, suggesting that gut microbiome dysregulation may extend to pediatric patients with HS and should be investigated further,' wrote the authors, from the Department of Dermatology at Boston University School of Medicine, Boston. Gut Dysbiosis and Reduced Microbial Diversity in HS The study included 16 participants — eight participants with HS and eight matched control participants — half of whom were younger than 18 years. Although beta diversity (variation between individuals) was similar across groups, a decrease in alpha diversity (diversity within an individual's gut microbiome) was observed in participants with HS, as measured using Pielou evenness. 'This may indicate gut dysbiosis,' the authors noted. In pediatric patients with HS, there were notable shifts in microbial composition. Bifidobacterium adolescentis was present in all pediatric patients with HS but absent in all adults with HS. 'As B adolescentis abundance typically increases with age, its absence in adults with HS may indicate dysregulation in gut microbiome maturation,' the authors explained. Other notable findings in the pediatric patients with HS included increases in Ruminococcus , Clostridium , and Bilophila . An increase in the beneficial bacterium Faecalibacterium prausnitzii was also noted compared with pediatric control participants. Clinical Implications and Future Directions Asked to comment on this emerging research, Tamia Harris-Tryon, MD, PhD, associate professor of dermatology and immunology at UT Southwestern Medical Center in Dallas, said the results highlight a nutritional component to HS that warrants greater attention. 'HS patients often have diets that are deficient in fiber and other nutrients,' she explained. 'The gut microbiome is directly linked to diet. A diet low in fiber will be deficient in microbes that ferment fiber. Fiber fermentation influences the immune system.' Harris-Tryon added that the new findings, particularly in children, emphasize the need for diet-based interventions. 'HS patients, especially pediatric patients, need to be meeting with a nutritionist,' she said. 'The emphasis should be on increasing fiber and nutrient-dense foods in the diet, while dropping high-glycemic index foods such as candy, soda, fruit juice, sweet teas, and cutting packaged and ultraprocessed foods.' While microbiome-targeted treatments such as probiotics are often discussed in chronic inflammatory skin conditions, Harris-Tryon advised caution. 'There is no data for microbiome-directed therapies in HS yet,' she said. 'But there is significant data on the benefits of a nutrient-dense, fiber-rich diet in pediatric patients and the influence of diet on the gut microbiome. Diets from all over the world with components similar to the Mediterranean diet have been shown to be the most beneficial for human health, including skin health. Fermented foods are an excellent time-tested source of beneficial microbes — including low sugar yogurt, kimchi, and kefir.' In a recent episode of the Medscape InDiscussion podcast series on HS and the microbiome, Harris-Tryon emphasized that 'understanding how the gut, skin, and immune system talk to each other is going to be key to developing future treatments for HS' and noted that this area of research 'is really just beginning to open up.' The study authors also encouraged future studies to examine potential interactions between the gut and the brain. ' B adolescentis produces gamma-aminobutyric acid [GABA], a mediator of the gut-brain axis that has been associated with anxiety and depression disorders through direct modulation of neural signals from the gut,' they wrote. 'As HS can affect mental health, particularly in vulnerable pediatric populations, it may be worthwhile to incorporate mental health screenings in future studies and assess correlations with GABA-producing microbes.' Noting that the study had limitations, such as a small sample size and the lack of matching by BMI or disease duration, the authors concluded that there were significant differences in the gut microbiome of pediatric patients with HS compared with pediatric control participants and adults with HS. The authors also referred to their previous study, which observed an increase in Bilophila and a decrease in Pielou evenness alpha diversity in both pediatric and adult patients with HS compared to control participants, pointing to potential gut dysbiosis. Collectively, the authors noted these findings suggest that 'gut microbiome dysregulation may extend to pediatric patients with HS and should be investigated further.' The study was independently supported by institutional grants from Boston University. The authors reported having no conflicts of interest. Harris-Tryon disclosed serving or having served as a director, officer, partner, employee, advisor, consultant, or trustee for Mirofend and Johnson & Johnson; serving as a speaker or a member of a speaker bureau for Tamia; and receiving research grants from LEO Pharmaceuticals.
Yahoo
09-05-2025
- Business
- Yahoo
Zura Bio Reports First Quarter 2025 Financial Results and Recent Corporate Updates
Advanced the Phase 2 TibuSURE clinical trial evaluating tibulizumab in adults with systemic sclerosis (SSc) Continued preparations for the planned Phase 2 trial evaluating tibulizumab in adults with hidradenitis suppurativa (HS), expected to initiate in Q2 2025 Strengthened the team with a strategic appointment to support clinical execution and organizational growth $170.6 million in cash and cash equivalents with cash runway anticipated through 2027 HENDERSON, Nev., May 08, 2025--(BUSINESS WIRE)--Zura Bio Limited (Nasdaq: ZURA) ("Zura Bio" or the "Company"), a clinical-stage, multi-asset immunology company developing novel dual-pathway antibodies for a range of autoimmune and inflammatory diseases, today reported financial results for the first quarter ended March 31, 2025, and provided recent corporate updates. "The first quarter of 2025 reflected steady progress across our clinical and operational priorities," said Robert Lisicki, Chief Executive Officer of Zura Bio. "We continued advancing trial efforts for our Phase 2 TibuSURE trial for adults with SSc, and progressed preparations for the initiation of a second Phase 2 study in HS. Recent additions to our clinical team have further strengthened our ability to grow and execute with care. We believe we are well-positioned to move our programs forward thoughtfully and purposefully." PIPELINE HIGHLIGHTS AND UPCOMING ANTICIPATED MILESTONES Tibulizumab Systemic sclerosis In the first quarter of 2025, Zura Bio continued to advance its ongoing Phase 2 TibuSURE trial evaluating tibulizumab in adults with SSc. Hidradenitis suppurativa In the first quarter of 2025, Zura Bio received clearance from the U.S. Food and Drug Administration for its Investigational New Drug application for HS, supporting the planned initiation of its Phase 2 clinical trial in adults with HS in the second quarter of 2025. Crebankitug Zura Bio continues to explore the potential of crebankitug in immune-mediated diseases where dual inhibition of interleukin-7 (IL-7) and thymic stromal lymphopoietin (TSLP) may offer clinical benefits with commercial potential. The Company is conducting translational research and engaging with academic collaborators to inform future development decisions. Torudokimab Zura Bio is evaluating the potential role of torudokimab in inflammatory and respiratory diseases and monitoring external clinical data in areas such as asthma and chronic obstructive pulmonary disease to inform its development strategy. CORPORATE HIGHLIGHTS In the first quarter, Zura Bio appointed Kate Dingwall as Senior Vice President of Development Operations. Ms. Dingwall brings extensive experience in patient-centered trial design, recruitment strategies, and clinical optimization and is expected to help advance the Company's pipeline and lead execution across current and future clinical programs. FIRST QUARTER 2025 FINANCIAL RESULTS Cash Position As of March 31, 2025, Zura Bio had cash and cash equivalents of $170.6 million. Zura Bio anticipates that its existing cash and cash equivalents should be sufficient to support operations as currently planned through 2027. Research and Development (R&D) Expenses R&D expenses for the first quarter of 2025 were $10.5 million, compared to $3.6 million for the first quarter of 2024. The increase was primarily driven by increases of $3.7 million for contract research organization (CRO) costs and $2.1 million for manufacturing costs for our product candidates, as well as $0.6 million for cash and non-cash compensation costs for personnel in research and development functions as we advance our Phase 2 clinical trials evaluating tibulizumab in SSc and HS. General and Administrative (G&A) Expenses G&A expenses for the first quarter of 2025 were $8.8 million, compared to $4.8 million for the first quarter of 2024. The increase was primarily due to a $2.6 million increase in cash and non-cash compensation costs for personnel in executive and administrative functions and our board of directors, as well as a $1.2 million increase in professional fees to support our growing organization as we advance our Phase 2 clinical trials evaluating tibulizumab in SSc and HS. Net Loss Net loss for the first quarter of 2025 was $17.4 million, or $0.19 per share, compared to $7.7 million, or $0.02 per share, for the same period in 2024. ABOUT ZURA BIO Zura Bio is a clinical-stage, multi-asset immunology company developing novel antibodies for autoimmune and inflammatory diseases. The Company's pipeline includes dual-pathway product candidates designed to target key mechanisms of immune system imbalance, with the goal of improving efficacy, safety, and dosing convenience for patients. Zura Bio's lead product candidate, tibulizumab (ZB-106), is currently being evaluated in TibuSURE, a Phase 2 clinical trial in adults with systemic sclerosis. It is also expected to enter a separate Phase 2 clinical trial in adults with hidradenitis suppurativa in the second quarter of 2025. Additional product candidates, crebankitug (ZB-168) and torudokimab (ZB-880), have completed Phase 1/1b studies and are being evaluated for their potential across a range of autoimmune and inflammatory conditions. For more information, please visit FORWARD-LOOKING STATEMENTS This communication includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Words such as "expect," "estimate," "project," "budget," "forecast," "anticipate," "intend," "plan," "may," "will," "could," "should," "believe," "predict," "potential," "continue," "strategy," "future," "opportunity," "would," "seem," "seek," "outlook," "goal," "mission," and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties that could cause the actual results to differ materially from the expected results. These statements are based on various assumptions, whether or not identified in this communication. These forward-looking statements in this release include, but are not limited to, statements regarding: Zura Bio's forecasts, including with respect to its cash resources; Zura Bio's expectations regarding funding, operating and working capital expenditures, business strategies and objectives; expectations with respect to Zura Bio's development program, including its product candidates and the potential clinical benefits and commercial potential thereof, data readouts, regulatory matters, clinical trials and the design and timing thereof; expectations with respect to development programs, data readouts and product candidates of other parties. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events are difficult or impossible to predict and could differ materially from those expressed or implied in such forward-looking statements, as a result of these risks and uncertainties, which include, but are not limited to: Zura Bio's expectations regarding its product candidates and their related clinical benefits, and Zura Bio's beliefs regarding competing product candidates and products both in development and approved, may not be achieved; Zura Bio's vision and strategy may not be successful; the timing of key events and initiation of Zura Bio's studies, regulatory matters and release of clinical data may take longer than anticipated or may not be achieved at all; the potential general acceptability and maintenance of Zura Bio's product candidates by regulatory authorities, payors, physicians, and patients may not be achieved; Zura Bio's ability to attract and retain key personnel; Zura Bio's expectations with respect to its future operating expenses, capital requirements and needs for additional financing may not be achieved; Zura Bio has not completed any clinical trials, and has no products approved for commercial sale; Zura Bio has incurred significant losses since inception, and expects to incur significant losses for the foreseeable future and may not be able to achieve or sustain profitability in the future; Zura Bio requires substantial additional capital to finance its operations, and if it is unable to raise such capital when needed or on acceptable terms, Zura Bio may be forced to delay, reduce, and/or eliminate one or more of its development programs or future commercialization efforts; Zura Bio may be unable to renew existing contracts or enter into new contracts; Zura Bio relies on third-party contract development manufacturing organizations for the manufacture of clinical materials; Zura Bio relies on contract research organizations, clinical trial sites, and other third parties to conduct of its preclinical studies and clinical trials; Zura Bio may be unable to obtain regulatory approval for its product candidates, and there may be related restrictions or limitations of any approved products; Zura Bio may be unable to successfully respond to general economic and geopolitical conditions; Zura Bio may be unable to effectively manage growth; Zura Bio faces competitive pressures from other companies worldwide; Zura Bio may be unable to adequately protect its intellectual property rights; and other factors set forth in documents filed, or to be filed by Zura Bio, with the Securities and Exchange Commission (SEC), including the risks and uncertainties described in the "Risk Factors" section of Zura Bio's Annual Report on Form 10-K for the year ended December 31, 2024 and Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2025, and other filings with the SEC. These risks and uncertainties may be amplified by health epidemics or other unanticipated global disruption events, including the conflict between Russia and Ukraine and the Israel-Hamas war and sanctions related thereto, international trade policies, including tariffs, inflation, increased interest rates, uncertain global credit and capital markets and disruptions in banking systems, which may continue to cause economic uncertainty. Zura Bio cautions that the foregoing list of factors is not exclusive or exhaustive and not to place undue reliance upon any forward-looking statements, which speak only as of the date made. Zura Bio gives no assurance that it will achieve its expectations. Zura Bio does not undertake or accept any obligation to update any forward-looking statements, except as required by law. ZURA BIO LIMITED CONSOLIDATED BALANCE SHEETS (In thousands, except share data) March 31, December 31, 2025 2024 (unaudited) Assets Current assets Cash and cash equivalents $ 170,569 $ 176,498 Prepaid expenses and other current assets 1,123 2,246 Total current assets 171,692 178,744 Property and equipment, net 106 91 Other assets 698 698 Total assets $ 172,496 $ 179,533 Liabilities, Redeemable Noncontrolling Interest and Shareholders' Equity Current liabilities Accounts payable and accrued expenses $ 21,092 $ 19,514 Total current liabilities 21,092 19,514 Total liabilities 21,092 19,514 Commitments and contingencies Redeemable noncontrolling interest 11,663 11,663 Shareholders' Equity Preferred shares, $0.0001 par value, 1,000,000 authorized as of March 31, 2025 and December 31, 2024; no shares issued and outstanding as of March 31 2025 and December 31, 2024 - - Class A Ordinary Shares, $0.0001 par value; 300,000,000 shares authorized as of March 31, 2025 and December 31, 2024; 68,374,998 and 65,297,530 shares issued and outstanding as of March 31, 2025 and December 31, 2024, respectively 7 7 Additional paid-in capital 311,532 302,705 Accumulated deficit (173,339 ) (155,897 ) Total Zura Bio Limited shareholders' equity 138,200 146,815 Noncontrolling interest 1,541 1,541 Total shareholders' equity 139,741 148,356 Total liabilities, redeemable noncontrolling interest and shareholders' equity $ 172,496 $ 179,533 ZURA BIO LIMITED CONSOLIDATED STATEMENTS OF OPERATIONS (In thousands, except share and per share data) unaudited For the Three Months Ended March 31 2025 2024 Operating expenses: Research and development $ 10,474 $ 3,593 General and administrative 8,780 4,786 Total operating expenses 19,254 8,379 Loss from operations (19,254 ) (8,379 ) Other (income)/expense, net Interest income (1,817 ) (1,215 ) Change in fair value of private placement warrants - 606 Other expense (income), net 5 (23 ) Total other income, net (1,812 ) (632 ) Loss before income taxes (17,442 ) (7,747 ) Income tax benefit - - Net loss (17,442 ) (7,747 ) Adjustment of redeemable noncontrolling interest from redemption value to carrying value - 7,017 Net loss attributable to Class A Ordinary Shareholders of Zura $ (17,442 ) $ (730 ) Net loss per share attributable to Class A Ordinary Shareholders of Zura, basic and diluted $ (0.19 ) $ (0.02 ) Weighted-average Class A Ordinary Shares used in computing net loss per share attributable to Class A Ordinary Shareholders of Zura, basic and diluted 92,964,048 46,914,542 View source version on Contacts Megan K. WeinshankHead of Corporate Affairsir@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
