Latest news with #Sjögren
Medscape
10 hours ago
- Health
- Medscape
Leflunomide, HCQ Combo Effects Validated in Sjögren Disease
BARCELONA, Spain — In the treatment of primary Sjögren disease, the use of leflunomide (LEF) and hydroxychloroquine (HCQ) in combination was associated with a greater reduction in disease activity than placebo, according to new trial results reported at the European Alliance of Associations for Rheumatology (EULAR) 2025 Annual Meeting. In the randomized controlled RepurpSS-II trial, the LEF-HCQ combination produced a mean decrease in EULAR Sjögren syndrome disease activity index (ESSDAI) score of 4.13 points ( P = .001) relative to placebo after 24 weeks of treatment. There were also greater reductions in serum immunoglobulin G, rheumatoid factor, and complement component 4 with the combination than with placebo. However, there were no differences between the groups in terms of patients' symptoms as measured by the EULAR Sjögren syndrome patient reported index (ESSPRI) or its separate components. There were also no differences between the groups in improving dryness as measured using the Schirmer and unstimulated saliva tests. Confirmatory Trial Wing-Yi Wong, MD 'The major challenge in this disease is the lack of standard treatments, despite the need,' said Wing-Yi Wong, MD, a PhD student at University Medical Center Utrecht, Utrecht, the Netherlands, who presented the findings as a late-breaking abstract. 'Many trials in the past 40 years have failed to show clinical efficacy,' Wong added. One of the few trials that had proven promising previously, however, was the RepurpSS-I trial, which had tested a combination of LEF at a dose of 20 mg/d and HCQ at a dose of 400 mg/d given for 24 weeks vs placebo. RepurpSS-II was set up to confirm the findings of RepurpSS-I. Published in The Lancet Rheumatology in 2020, RepurpSS-I had shown that LEF-HCQ reduced ESSDAI a mean of 4.29 points more than that with placebo. Trial Designs and RepurpSS-II Population RepurpSS-I was a phase 2a trial, and RepurpSS-II was a phase b2 trial. Entry criteria were similar for both trials: Primary Sjögren disease diagnosis, an ESSDAI ≥ 5, and no significant comorbidities. Women of a child-bearing age also had to be taking reliable contraception. Both RepurpSS trials included 24-week double-blind treatment phases, with RepurpSS-II adding a single-arm crossover extension for a further 24 weeks. A total of 37 people with primary Sjögren disease had been screened for inclusion in RepurpSS-I, 29 were included, 21 of whom were treated with the LEF-HCQ combination and eight with placebo. For RepurpSS-II, 85 of 233 people who were considered for inclusion were screened, and 46 were included in the trial. Of these, 21 were treated with LEF-HCQ and 25 with placebo. Among the reasons for not screening or including more people in RepurpSS-II were comorbidities; current or recent treatment with LEF, HCQ, or other disease-modifying antirheumatic drugs; and not meeting other entry criteria. Participants in the LEF-HCQ and placebo groups of RepurpSS-II were demographically similar: The mean age was 55 years; 90.5% and 96.0%, respectively, were women; and the mean disease durations were 6.5 years and 10.0 years, respectively. Mean ESSDAI scores at baseline were 9.52 in the LEF-HCQ group and 9.88 in the placebo group, and mean ESSPRI scores were 7.00 and 6.83, respectively. Other Findings Exploratory analyses using the Sjögren's Tool for Assessing Response (STAR) and the Composite of Relevant Endpoints for Sjögren Syndrome (CRESS) also favored LEF-HCQ. 'STAR and CRESS scores are two novel composite endpoints that includes patient-reported outcomes together with objective measures of dryness alongside the clinical ESSDAI,' Wong said. She reported that there was a 'significantly higher percentage of responders' in the LEF-HCQ group using both measures vs placebo. Adverse event rates were similar between groups: A total of 58 events occurred in the LEF-HCQ group and 57 in the placebo group. Most of these events were considered as mild (77.6% for LEF-HCQ and 66.7% for placebo), with gastrointestinal discomfort and respiratory infections among the most commonly reported. Two severe adverse events occurred, one in each group, and were deemed unrelated to the study treatment. The one in the LEF-HCQ group was a non-ST elevation myocardial infarction, and the one in the placebo group was an allergic reaction to antibiotic treatment. A total of 14 patients in the LEF-HCQ group completed the double-blind phase, and nine chose to enter the 24-week, open-label extension. Although completed, results of this phase are pending. 'Overall, the combination treatment was well tolerated, and leflunomide-hydroxychloroquine is realistic treatment option, which is affordable, accessible, and widely available,' Wong concluded. This study was funded by the Dutch independent government body ZonMw . Wong and fellow investigators for the RepurpSS-II study had no relevant conflicts of interest.
Yahoo
30-05-2025
- Business
- Yahoo
Immunovant Provides Corporate Updates and Reports Financial Results for the Fourth Quarter and Fiscal Year Ended March 31, 2025
Immunovant's new management team is focused on rapid clinical execution for the six announced indications for IMVT-1402, including a second potentially registrational study in Graves' disease (GD) and a potentially registrational study in Sjögren's disease (SjD), both expected to start in summer 2025 Positive data from first-generation batoclimab trials in myasthenia gravis (MG) and chronic inflammatory demyelinating polyneuropathy (CIDP) demonstrated that deeper IgG reductions correlated with improved clinical outcomes across a range of assessments and timepoints suggesting a potential best-in-class efficacy profile for IMVT-1402 Current cash balance provides runway for announced indications through GD readout expected in 2027 NEW YORK, May 29, 2025 (GLOBE NEWSWIRE) -- Immunovant, Inc. (Nasdaq: IMVT), a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases, today reported corporate updates and financial results for its fourth quarter and fiscal year ended March 31, 2025. Recent Highlights and Upcoming Milestones: In April 2025, Immunovant announced changes to its leadership team as part of a broader strategic transition with Roivant increasing operational involvement and oversight of Immunovant. Eric Venker, M.D. was appointed as CEO of Immunovant, and Tiago Girao as CFO of Immunovant. Given the strength of its potential best-in-class profile, IMVT-1402 is being developed in six announced indications, including potentially registrational trials in Graves' disease (GD), difficult-to-treat rheumatoid arthritis (D2T RA), myasthenia gravis (MG), chronic inflammatory demyelinating polyneuropathy (CIDP) and Sjögren's disease (SjD), and a proof-of-concept trial in cutaneous lupus erythematosus (CLE). In March 2025, Immunovant announced positive results from its batoclimab MG and CIDP studies. The potentially registrational study in MG met its primary endpoint of change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) score in the AChR+ population at week 12, with the higher dose arm achieving a 5.6-point improvement (with 74% mean IgG reduction) and the lower dose arm achieving a 4.7-point improvement (with 64% mean IgG reduction). Initial results from week 12 of the Phase 2b CIDP study demonstrated a mean improvement in the adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score of 1.8 across batoclimab arms and an 84% responder rate in those patients who achieved an IgG lowering greater than 70%. In both batoclimab studies, deeper IgG reductions correlated with improved clinical outcomes across a range of assessments and timepoints. Potentially registrational trials for IMVT-1402 in both MG and CIDP are actively enrolling. In March 2025, Immunovant initiated a potentially registrational trial of IMVT-1402 in adult participants with active, anti-citrullinated protein autoantibody (ACPA) positive D2T RA and a proof-of-concept study in CLE. Both indications represent potential first-in-class and best-in-class opportunities based on positive in-class competitor data (D2T RA) and promising efficacy data from patients dosed with IMVT-1402 as part of an open-label case study program (CLE). Immunovant plans to initiate a potentially registrational trial evaluating IMVT-1402 in SjD and a second potentially registrational trial in GD in the summer of 2025. Immunovant expects to report batoclimab six-month remission data from the proof-of-concept study in GD in the summer of 2025 and Phase 3 thyroid eye disease (TED) data in the second half of calendar year 2025. Financial Highlights for Fiscal Fourth Quarter Ended March 31, 2025: Cash Position: As of March 31, 2025, Immunovant's cash and cash equivalents totaled approximately $714 million, providing runway for announced indications through GD readout expected in 2027. R&D Expenses: Research and development expenses were $93.7 million for the three months ended March 31, 2025, compared to $66.1 million for the three months ended March 31, 2024. The increase was primarily due to activities related to our clinical trials of IMVT-1402, including contract manufacturing costs and elevated personnel-related expenses. The increase was partially offset by lower overall costs related to our IMVT-1402 Phase 1 trial and nonclinical studies. G&A Expenses: General and administrative expenses were $20.2 million for the three months ended March 31, 2025, compared to $14.8 million for the three months ended March 31, 2024. The increase was primarily due to higher personnel-related expenses, information technology costs, legal and other professional fees, and market research costs. Net Loss: Net loss was $106.4 million ($0.64 per common share) for the three months ended March 31, 2025, compared to $75.3 million ($0.52 per common share) for the three months ended March 31, 2024. Net loss for the three months ended March 31, 2025 and March 31, 2024 included $11.7 million and $9.7 million, respectively, related to non-cash stock-based compensation expense. Common Stock: As of March 31, 2025, there were 170,111,593 shares of common stock issued and outstanding. Financial Highlights for Fiscal Year Ended March 31, 2025: R&D Expenses: Research and development expenses were $360.9 million for the fiscal year ended March 31, 2025, compared to $212.9 million for the fiscal year ended March 31, 2024. The increase was primarily due to activities related to our clinical trials of IMVT-1402, including contract manufacturing costs, elevated personnel-related expenses, and higher overall clinical trial costs related to our batoclimab pivotal clinical trials. The increase was partially offset by lower overall costs related to our IMVT-1402 Phase 1 trial and nonclinical studies. IPR&D Expenses: There were no acquired in-process research and development expenses for the fiscal year ended March 31, 2025. During the fiscal year ended March 31, 2024, acquired in-process research and development expenses were $12.5 million related to the achievement of development and regulatory milestones for batoclimab under the terms of the HanAll in-license agreement. G&A Expenses: General and administrative expenses were $77.2 million for the fiscal year ended March 31, 2025, compared to $57.3 million for the fiscal year ended March 31, 2024. The increase was primarily due to higher personnel-related expenses, professional fees, information technology costs, and market research costs. Net Loss: Net loss was $413.8 million ($2.73 per common share) for the fiscal year ended March 31, 2025, compared to $259.3 million ($1.88 per common share) for the fiscal year ended March 31, 2024. Net loss for the fiscal year ended March 31, 2025 and 2024 included $49.5 million and $41.1 million, respectively, related to non-cash stock-based compensation expense. About Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As a trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases. For additional information on the Company, please visit Forward-Looking StatementsThis press release contains forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as "can," 'may,' 'might,' 'will,' 'would,' 'should,' 'expect,' 'believe,' 'estimate,' 'design,' 'plan,' "intend," and other similar expressions are intended to identify forward-looking statements. Such forward looking statements include statements regarding Immunovant's expectations regarding the timing, design, and results of clinical trials of IMVT-1402; Immunovant's plan to develop IMVT-1402 and batoclimab across a broad range of indications; the number and timing of potentially registrational programs and clinical trials Immunovant plans to initiate for IMVT-1402; and potential benefits of IMVT-1402's unique product attributes and potential best-in-class and first-in-class profile. All forward-looking statements are based on estimates and assumptions by Immunovant's management that, although Immunovant believes to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Immunovant expected. Such risks and uncertainties include, among others: Immunovant may not be able to protect or enforce its intellectual property rights; initial results or other preliminary analyses or results of early clinical trials may not be predictive final trial results or of the results of later clinical trials; the timing and availability of data from clinical trials; the timing of discussions with regulatory agencies, as well as regulatory submissions and potential approvals; the continued development of Immunovant's product candidates, including the number and timing of the commencement of additional clinical trials; Immunovant's scientific approach, clinical trial design, indication selection, and general development progress; future clinical trials may not confirm any safety, potency, or other product characteristics described or assumed in this press release; any product candidate that Immunovant develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; Immunovant's product candidates may not be beneficial to patients, or even if approved by regulatory authorities, successfully commercialized; the potential impact of global factors, such as international trade tariffs, geopolitical tensions, and adverse macroeconomic conditions on Immunovant's business operations and supply chain, including its clinical development plans and timelines; Immunovant's business is heavily dependent on the successful development, regulatory approval, and commercialization of IMVT-1402 or batoclimab; Immunovant is at various stages of clinical development for IMVT-1402 and batoclimab; and Immunovant will require additional capital to fund its operations and advance IMVT-1402 and batoclimab through clinical development. These and other risks and uncertainties are more fully described in Immunovant's periodic and other reports filed with the Securities and Exchange Commission (SEC), including in the section titled 'Risk Factors' in Immunovant's Annual Report on Form 10-K filed with the SEC on May 29, 2025, and Immunovant's subsequent filings with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Immunovant undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or INC. Consolidated Statements of Operations (In thousands, except share and per share data) Three Months EndedMarch 31, Years EndedMarch 31, 2025 2024 2025 2024 Operating expenses: Research and development $ 93,652 $ 66,056 $ 360,917 $ 212,928 Acquired in-process research and development — — — 12,500 General and administrative 20,174 14,823 77,235 57,281 Total operating expenses 113,826 80,879 438,152 282,709 Interest income (6,889 ) (8,379 ) (24,732 ) (24,948 ) Other (income) expense, net (1,071 ) 2,587 (471 ) 1,008 Loss before provision for income taxes (105,866 ) (75,087 ) (412,949 ) (258,769 ) Provision for income taxes 583 232 891 567 Net loss $ (106,449 ) $ (75,319 ) $ (413,840 ) $ (259,336 ) Net loss per common share – basic and diluted $ (0.64 ) $ (0.52 ) $ (2.73 ) $ (1.88 ) Weighted-average common shares outstanding – basic and diluted 166,732,686 145,355,546 151,573,553 138,100,577 IMMUNOVANT, Balance Sheets(In thousands, except share and per share data) March 31, 2025 2024 Assets Current assets: Cash and cash equivalents $ 713,971 $ 635,365 Accounts receivable 2,084 5,337 Prepaid expenses and other current assets 51,180 24,902 Income tax receivable 427 166 Total current assets 767,662 665,770 Operating lease right-of-use assets 98 133 Property and equipment, net 844 462 Other assets 7,618 — Total assets $ 776,222 $ 666,365 Liabilities and Stockholders' Equity Current liabilities: Accounts payable $ 17,656 $ 7,155 Accrued expenses 50,748 41,300 Current portion of operating lease liabilities 98 138 Due to Roivant Sciences Ltd. 273 15 Total current liabilities 68,775 48,608 Total liabilities 68,775 48,608 Commitments and contingencies Stockholders' equity: Series A preferred stock, par value $0.0001 per share, 10,000 shares authorized, issued and outstanding at March 31, 2025 and March 31, 2024 — — Preferred stock, par value $0.0001 per share, 10,000,000 shares authorized, no shares issued and outstanding at March 31, 2025 and March 31, 2024 — — Common stock, par value $0.0001 per share, 500,000,000 shares authorized, 170,111,593 shares issued and outstanding at March 31, 2025 and 500,000,000 shares authorized, 145,582,999 shares issued and outstanding at March 31, 2024 16 14 Additional paid-in capital 1,945,495 1,441,518 Accumulated other comprehensive income 1,459 1,908 Accumulated deficit (1,239,523 ) (825,683 ) Total stockholders' equity 707,447 617,757 Total liabilities and stockholders' equity $ 776,222 $ 666,365 Contacts:Investors Keyur Media Stephanie 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
Yahoo
28-05-2025
- Business
- Yahoo
Artiva Biotherapeutics to Participate in the Jefferies Global Healthcare Conference
SAN DIEGO, May 28, 2025 (GLOBE NEWSWIRE) -- Artiva Biotherapeutics, Inc. (Nasdaq: ARTV), a clinical-stage biotechnology company whose mission is to develop effective, safe, and accessible cell therapies for patients with devastating autoimmune diseases and cancers, announced today that management will participate in a fireside chat at the Jefferies Global Healthcare Conference on Wednesday, June 4, 2025, at 9:20 a.m. EDT. Members of the Artiva management team will also be available to participate in investor meetings with investors who are registered to attend the conference. Investors and the general public are invited to listen to a live webcast of the presentation through the "Investors" section on A webcast replay will be made available following the event for 90 days. About Artiva Biotherapeutics Artiva is a clinical-stage biotechnology company whose mission is to develop effective, safe and accessible cell therapies for patients with devastating autoimmune diseases and cancers. Artiva's lead program, AlloNK® (also known as AB-101), is an allogeneic, off-the-shelf, non-genetically modified, cryopreserved NK cell therapy candidate designed to enhance the antibody-dependent cellular cytotoxicity effect of monoclonal antibodies to drive B-cell depletion. AlloNK is currently being evaluated in three ongoing clinical trials for the treatment of B-cell driven autoimmune diseases. This includes two company-sponsored trials, one in systemic lupus erythematosus for patients with or without lupus nephritis, and a basket trial across autoimmune diseases including rheumatoid arthritis and Sjögren's disease, as well as an investigator-initiated basket trial in B-cell driven autoimmune diseases. Artiva's pipeline also includes CAR-NK candidates targeting both solid and hematologic cancers. Artiva was founded in 2019 as a spin out of GC Cell, formerly GC Lab Cell Corporation, a leading healthcare company in the Republic of Korea, pursuant to a strategic partnership granting Artiva exclusive worldwide rights (excluding Asia, Australia and New Zealand) to GC Cell's NK cell manufacturing technology and programs. Artiva is headquartered in San Diego, California. For more information, please visit Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements in this press release that are not statements of historical fact are forward-looking statements. Such forward-looking statements include, without limitation, statements regarding upcoming events or Artiva Biotherapeutics, Inc.'s (the 'Company') participation at such events. These forward-looking statements are based on the beliefs of the management of the Company as well as assumptions made by and information currently available to the Company. Such statements reflect the current views of the Company with respect to future events and are subject to known and unknown risks and uncertainties. In light of these risks and uncertainties, the events or circumstances referred to in the forward-looking statements may not occur. These and other factors that may cause the Company's actual results to differ from current expectations are discussed in the Company's filings with the Securities and Exchange Commission (the 'SEC'), including the section titled 'Risk Factors' in the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2025. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date this press release is given. Except as required by law, the Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise. ContactsInvestors: Neha Krishnamohan, Artiva Biotherapeutics, ir@ Jessica Yingling, Ph.D., Little Dog Communications Inc., jessica@ +1.858.344.8091 Source: Artiva Biotherapeutics, 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
