Latest news with #systemicsclerosis
CNA
23-05-2025
- Health
- CNA
Systemic sclerosis causes 1 in 2 deaths within 4 years of diagnosis
A S$6 million grant at the Singapore General Hospital will fund a new project for systemic sclerosis patients. The aim is to better diagnosis and personalised treatment for the disease that has poor survival rates, killing one in two Asian patients within four years of diagnosis. Researchers will analyse patients' genes, immune systems, gut bacteria and more over the next five years. Associate Professor Andrea Low, Lead of the Singapore Systemic Sclerosis Precision Medicine Project and Senior Consultant at SGH, explains why Asian patients have poor survival rates with this disease and the factors contributing to it. She also points out how the Singapore Systemic Sclerosis Precision Medicine Project differs from existing programmes treating this disease.
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
Medscape
06-05-2025
- Health
- Medscape
Does Immunosuppression Prevent PAH in Systemic Sclerosis?
MANCHESTER, England — Use of immunosuppressive drugs within 5 years of the onset of systemic sclerosis (SSc) did not lower patients' risk for developing pulmonary arterial hypertension (PAH) but was associated with a significantly lower likelihood of death in patients with the complication, researchers reported at the British Society for Rheumatology (BSR) 2025 Annual Meeting. Senior author for the study, Christopher Denton, MD, PhD, professor of experimental rheumatology at UCL Medical School and head of the Centre for Rheumatology at the Royal Free Hospital, London, England, told Medscape Medical News , 'Pulmonary hypertension is one of the complications of scleroderma that has been thought traditionally not to be so inflammatory or immunologically driven. But we got an interesting signal, which was that patients who were on hydroxychloroquine seem to have a lower frequency of developing pulmonary hypertension' than those who were not using immunosuppressants. Christopher Denton, MD, PhD Denton noted that, generally speaking, hydroxychloroquine was thought to be 'quite a benign drug,' so the result begs the question as to whether it could be beneficial to give to people with SSc who may be at risk for developing PAH. 'It does suggest that maybe immunomodulation could be helpful, although hydroxychloroquine does lots of other things as well as immunomodulation,' and this was a small study, Denton cautioned. A 'Dreadful Complication' Stefano Rodolfi, MD, who presented the study's findings and works as a clinical research fellow at the Royal Free Hospital, said that PAH was 'one of the most dreadful complications' of SSc that affects an estimated 8%-13% of patients during the disease course. The 3-year survival rate is around 50%, he said. Stefano Rodolfi, MD It is 'a complication whose proposed pathophysiological mechanism is thought to start with an initial vascular injury to the pulmonary vasculature, leading to an aberrant fibroproliferatory repair process, progressive obliterative pulmonary vasculopathy, ultimately resulting in an increase in the mean pulmonary arterial pressures, increasing pulmonary vascular resistances, and right ventricular dysfunction,' Rodolfi explained. 'However, we have evidence for a role of immune dysfunction in the pathogenesis and pathophysiology,' he said. There are data showing that various autoantibodies are present, such as antibodies against the endothelin-1 receptor, angiotensin II receptor, and fibroblasts. There are also data suggesting a proinflammatory cytokine profile and the presence of activated monocytes in patients with SSc-PAH. 'Furthermore, we have indirect evidence on the role of immunosuppression in this complication,' Rodolfi added. Thus, one might expect that immunosuppression would be part of the management approach for SSc-PAH, but its 'treatment mirrors the same approach of the idiopathic counterpart of PAH, being based on a combination of vasodilatory and antiproliferative agents.' Study Overview Rodolfi explained that a retrospective analysis of 629 'well-characterized' patients with SSc was performed to answer two key questions: First, can early immune suppression prevent the development of PAH? Second, does immunosuppression alter survival in SSc-PAH? PAH was defined using the Venice definition of precapillary pulmonary hypertension: Mean pulmonary artery pressure ≥ 25 mm Hg, pulmonary vascular resistance > 3 Wood units, and a pulmonary wedge pressure ≤ 15 mm Hg. Rodolfi noted that this was a prior definition. After excluding patients with interstitial lung disease (ILD) that extended ≥ 20% on a high-resolution CT scan or who had a forced vital capacity < 70%, there were 607 patients available for analysis. Of these, 320 had received immunosuppression through their disease course, and 287 had not. Early Immunosuppression and Development of SSc-PAH For the first part of the analysis, patients were divided into three groups: Those who had received immunosuppression 'early,' ie, within the first 5 years of their SSc diagnosis (n = 206); those who had received immunosuppression 'late,' receiving it after 5 years of their SSc diagnosis (n = 144); and those who received no immunosuppression (n = 287). Immunosuppression was defined as treatment with glucocorticoids (prednisone equivalent ≥ 10 mg/d for ≥ 6 months) or conventional synthetic or biologic disease-modifying antirheumatic drugs. Over a median follow-up of 21 years, 77 patients developed PAH: 11 (5.3%) in the early immunosuppression group, 21 (14.6%) in the late suppression group, and 45 (15.7%) in the no suppression group. The difference between those with early immunosuppression and those without any use of immunosuppression was significant ( P < .001). However, after adjusting for potential confounding factors, such as male sex, diffuse cutaneous onset of SSc, ILD, scleroderma renal crisis, severe cardiac involvement, and presence of specific autoantibodies, there was no difference between the groups in terms of the time to developing PAH. Time to PAH was 'superimposable' across the three groups (10.5 vs 11 vs 11 years, respectively; P = .581), 'so we can conclude that early immune suppression did not significantly impact on the development of PAH,' Rodolfi reported. However, when analyzing the potential effects of individual immunosuppressive agents, treatment with mycophenolate mofetil (MMF) was associated with significantly reduced odds (odds ratio [OR], 0.12; P = .048) of developing PAH vs not using MMF. Other notable findings were that the presence of ILD, even if 'mild,' was associated with the development of PAH (OR, 3.01; P = .006). Other factors associated with increased risk for SSc-PAH were scleroderma renal crisis (OR, 6.54; P = .035) and the presence of anticentromere antibodies (OR, 2.94; P = .026). Conversely, the presence of anti–Scl-70 was associated with reduced odds of developing PAH (OR, 0.15; P = .009). The fact that MMF was associated with a reduced odds of developing SSc-PAH fits with other data, Rodolfi said. The drug has been shown to alleviate thickening of pulmonary arterial walls and inhibit abnormal vascular remodeling in a mouse model of PAH, and its efficacy has been reported in cases of PAH associated with other connective tissue diseases other than SSc. Mortality Impact For the second part of the analysis that examined the possible effect of immunosuppression on mortality in SSc-PAH, two groups of 'ever' (n = 30) or 'never' (n = 42) users of immunosuppression were formed. Rodolfi reported that more patients in the 'ever' than 'never' group had diffuse cutaneous SSc (20% vs 0%) and ILD (60% vs 14.6%), but fewer had anticentromere antibodies (55.2% vs 86.1%). Over a median follow-up of 7 years, 22 patients (73%) died in the 'ever' group and 30 died (71%) in the 'never' group. The median duration of survival from the time of PAH diagnosis was 7 years and 4 years, respectively, in the two groups (OR, 0.41; P = .045). 'When analyzing the impact of single agents, hydroxychloroquine was associated with reduced mortality risk,' Rodolfi said. Of the nine patients who had been treated with hydroxychloroquine, two died 17 years after their PAH diagnosis (hazard ratio, 0.04; P = .004). 'Once again, this is corroborated by preclinical evidence,' Rodolfi said, adding that it's not the first time either that hydroxychloroquine has been shown to have a possible beneficial clinical effect. Although a different endpoint was used, prior data have shown that treatment with hydroxychloroquine given in the first 18 months of SSc onset may reduce the risk for developing PAH. It is 'not quite the same finding as we had. Our signal was towards a benefit in survival, but still, something to corroborate the role of hydroxychloroquine in this setting.' Are There Any Practice Implications? But are the findings enough to have an impact on practice as it stands today? Consultant rheumatologist Carmel Stober, MD, PhD, who works for Cambridge University Hospitals NHS Trust, Cambridge, England, told Medscape Medical News that the results could potentially have an impact on how some patients with systemic sclerosis were treated. 'For example, if someone has got limited cutaneous systemic sclerosis, you would not necessarily get them on immunosuppression,' but you might give hydroxychloroquine if it has an effect on risk for PAH and there is a risk-benefit advantage for it, she said. The hypothesis is that PAH is modifiable by immunosuppression, Stober said, noting that the second part of the study looked at people who were already receiving immunosuppression and whether that decreased their risk for PAH. But the answer as to whether immunosuppression truly has that effect lies perhaps in a randomized controlled trial. Rodolfi noted that an ongoing multicenter, open-label, randomized trial of about 120 patients with limited cutaneous SSc in the United Kingdom is aiming to determine if MMF plus standard of care can slow down disease progression vs standard of care alone. The study's findings have been previously presented as a poster at the American College of Rheumatology (ACR) 2024 Annual Meeting. The study was independently supported. Rodolfi and Stober had no financial conflicts of interest to report. Denton reported receiving no financial relationships on the abstract but has in the past received speaker or advisory fees, research support, or clinical trial funding from various pharmaceutical companies, including Actelion, Pfizer, GlaxoSmithKline, Sanofi-Aventis, and Novartis.
