Systemic scleroderma

aTyr Pharma Announces Dosing of First Patient in Phase 2 EFZO-CONNECT™ Study of Efzofitimod in Patients with SSc-ILD

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星期二, 十月 31, 2023
FDA, Systemic scleroderma, Trial of the century, Food, Small RNA, NRP2, ATyr Pharma, Fibrosis, Skin, Sarcoidosis, Inflammation, Neuropilin, Quality of life, Lung, Disease, Cleveland, Autoimmune disease, Scar, Scleroderma, Safety, Cleveland Clinic, Patient, Food and Drug Administration, Toxicity, Death, Prognosis, Myelocyte, SAN, Pharmaceutical industry, ILD

The proof-of-concept study will evaluate the efficacy, safety and tolerability of the Company’s lead therapeutic candidate, efzofitimod, compared to placebo in patients with systemic sclerosis (SSc, or scleroderma)-related interstitial lung disease (ILD).

Key Points: 
  • The proof-of-concept study will evaluate the efficacy, safety and tolerability of the Company’s lead therapeutic candidate, efzofitimod, compared to placebo in patients with systemic sclerosis (SSc, or scleroderma)-related interstitial lung disease (ILD).
  • Efzofitimod has been granted U.S. Food and Drug Administration (FDA) and European Union orphan drug and U.S. FDA Fast Track designations for SSc.
  • “We are very pleased to begin patient dosing in EFZO-CONNECT™, which is our second clinical study for efzofitimod in ILD,” said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr.
  • aTyr is currently investigating efzofitimod in the global Phase 3 EFZO-FIT™ study in patients with pulmonary sarcoidosis, a major form of ILD, and in the Phase 2 EFZO-CONNECT™ study in patients with systemic sclerosis (SSc, or scleroderma)-related ILD.

AliveDx receives three IVDR CE marks for its Multiplexed Autoimmune Diagnostics Solution

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星期一, 十月 30, 2023
SLE, Laboratory, Systemic scleroderma, Centromere protein B, Mixed connective tissue disease, Life, MCTD, IVDR, Centromere, CE, Connective tissue, Health, Inflammatory myopathy, Autoimmune disease, Hospital, Workflow, Syndrome, Algorithm, European, CTD, Diagnosis, Patient, CE marking, DNA, Medical device, Scleroderma

EYSINS, Switzerland, Oct. 30, 2023 /PRNewswire/ -- AliveDx is proud to announce it has received three CE Marks for: Its MosaiQ Centromere Protein B (CENP-B) microarray, its MosaiQ AiPlex CTD (Connective Tissue Diseases) multiplexed microarray immunoassays and its MosaiQ AiPlex CTD Quality Controls.

Key Points: 
  • AliveDx receives three IVDR CE Marks for its automated, multiplexed MosaiQ® solution, enabling faster diagnosis of Connective Tissue Diseases (CTD)
    EYSINS, Switzerland, Oct. 30, 2023 /PRNewswire/ -- AliveDx is proud to announce it has received three CE Marks for: Its MosaiQ Centromere Protein B (CENP-B) microarray, its MosaiQ AiPlex CTD (Connective Tissue Diseases) multiplexed microarray immunoassays and its MosaiQ AiPlex CTD Quality Controls.
  • By launching its Autoimmune testing portfolio in the European Union and other CE Mark recognizing geographies, the company is providing laboratories and hospitals with a novel in-vitro diagnostics solution to enable improved workflow and faster time to diagnosis and treatment of patients suffering from Autoimmune diseases.
  • The MosaiQ solution combines a fully automated, ease to use, high throughput instrument platform, proprietary planar multiplexed microarray technology, and a smart image analysis algorithm to enable faster turn-around times for complex diagnostics pathways.
  • "We are excited to receive the CE Mark for our initial clinical multiplexed microarrays.

AliveDx receives three IVDR CE marks for its Multiplexed Autoimmune Diagnostics Solution

Retrieved on: 
星期一, 十月 30, 2023
SLE, Laboratory, Systemic scleroderma, Centromere protein B, Mixed connective tissue disease, Life, MCTD, IVDR, Centromere, CE, Connective tissue, Health, Inflammatory myopathy, Autoimmune disease, Hospital, Workflow, Syndrome, Algorithm, European, CTD, Diagnosis, Patient, CE marking, DNA, Medical device, Scleroderma

EYSINS, Switzerland, Oct. 30, 2023 /PRNewswire/ -- AliveDx is proud to announce it has received three CE Marks for: Its MosaiQ Centromere Protein B (CENP-B) microarray, its MosaiQ AiPlex CTD (Connective Tissue Diseases) multiplexed microarray immunoassays and its MosaiQ AiPlex CTD Quality Controls.

Key Points: 
  • AliveDx receives three IVDR CE Marks for its automated, multiplexed MosaiQ® solution, enabling faster diagnosis of Connective Tissue Diseases (CTD)
    EYSINS, Switzerland, Oct. 30, 2023 /PRNewswire/ -- AliveDx is proud to announce it has received three CE Marks for: Its MosaiQ Centromere Protein B (CENP-B) microarray, its MosaiQ AiPlex CTD (Connective Tissue Diseases) multiplexed microarray immunoassays and its MosaiQ AiPlex CTD Quality Controls.
  • By launching its Autoimmune testing portfolio in the European Union and other CE Mark recognizing geographies, the company is providing laboratories and hospitals with a novel in-vitro diagnostics solution to enable improved workflow and faster time to diagnosis and treatment of patients suffering from Autoimmune diseases.
  • The MosaiQ solution combines a fully automated, ease to use, high throughput instrument platform, proprietary planar multiplexed microarray technology, and a smart image analysis algorithm to enable faster turn-around times for complex diagnostics pathways.
  • "We are excited to receive the CE Mark for our initial clinical multiplexed microarrays.

Cabaletta Bio Receives FDA Clearance of IND Application for Treatment of Systemic Sclerosis with CABA-201

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星期一, 十月 2, 2023
Rheumatology, Food, Survival, Woman, Infertility, Skin manifestations of sarcoidosis, Lupus, Scleroderma, Myositis, CAR, Investigational New Drug, Patient, Risk, Autoimmune disease, Diagnosis, Mortality, American College, FDA, Pulmonary hypertension, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, IND, Systemic scleroderma, Skin, Autoantibody, Pharmaceutical industry

PHILADELPHIA, Oct. 02, 2023 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced that the Company’s third Investigational New Drug (IND) application for CABA-201, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy, has been allowed to proceed by the U.S. Food and Drug Administration (FDA) for a Phase 1/2 study in patients with systemic sclerosis (SSc). The Company plans to initiate a Phase 1/2 clinical trial of CABA-201 across two parallel SSc cohorts – one cohort of six patients with severe skin manifestations and a separate cohort of six patients with severe organ involvement associated with systemic sclerosis. Consistent with the previously announced CABA-201 IND clearances for lupus and myositis, the starting dose for the trial, 1 x 106 cells/kg, was informed by the high degree of similarity between CABA-201 and the CD19-CAR T construct administered to a patient with severe, diffuse SSc in the recent Annals of Rheumatic Diseases publication.

Key Points: 
  • The Company plans to initiate a Phase 1/2 clinical trial of CABA-201 across two parallel SSc cohorts – one cohort of six patients with severe skin manifestations and a separate cohort of six patients with severe organ involvement associated with systemic sclerosis.
  • SSc affects approximately 88,000 patients in the U.S., and typically affects middle-aged individuals, particularly women.
  • Standard treatment options, which have modest effects, include generalized immunosuppressive agents or drugs targeted to specific symptomatic manifestations.
  • Due to the lack of adequate treatments, the risk of mortality in systemic sclerosis remains high, with an average survival of approximately 12 years following diagnosis.

aTyr Pharma Presents Efzofitimod Data Demonstrating Statistically Significant Improvements in Time to Relapse, FVC and Patient Reported Outcomes

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星期一, 九月 11, 2023
Sarcoidosis, Myelocyte, European Respiratory Society, International, University, Small RNA, Neuropilin, Scar, ILD, OCS, Toxicity, FVC, Inflammation, Scleroderma, ERS, MCID, Prednisone, Fibrosis, ATyr Pharma, Patient, SAN, Poster, Systemic scleroderma, International Congress on Tuberculosis, Safety, Pharmaceutical industry, Dietary supplement, PRO, Medicine

SAN DIEGO, Sept. 11, 2023 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: LIFE) (aTyr or the Company), a clinical stage biotechnology company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced the results of a post-hoc analysis of data from its Phase 1b/2a study of efzofitimod in patients with pulmonary sarcoidosis. The analysis was presented in a poster at the European Respiratory Society (ERS) International Congress 2023, which is taking place September 9 – 13, 2023, in Milan, Italy. The poster is available on the Company’s website.

Key Points: 
  • 7.7% of patients in the 3.0 and 5.0 mg/kg efzofitimod group relapsed following steroid taper, compared to 54.4% in the placebo and efzofitimod 1.0 mg/kg group (p=0.017).
  • This is one of the few studies to demonstrate a steroid sparing effect of a drug associated with a significant improvement in patient outcome.
  • Dose dependent improvements in steroid burden, FVC and patient reported outcomes (PRO) were noted, though the study was not powered for efficacy.
  • These forms of ILD have limited therapeutic options and there is a need for safer and more effective, disease-modifying treatments that improve outcomes.

Advancing Autoimmune Disease Diagnostics Market: Surging Towards $9.84 Billion by 2030 with 7.2% CAGR - ResearchAndMarkets.com

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星期一, 九月 11, 2023
Health, Other Health, Systemic, Prevalence, Rheumatoid factor, Abbott Laboratories, ESR, Elia, BD (company), SLE, Approximation error, Creative Diagnostics, Compound annual growth rate, Incidence, Hospital, CRP, ANA, Thermo Fisher Scientific, Investment, PerkinElmer, Autoimmune disease, Growth, Diagnosis, Mindful Scientific Inc., Systemic scleroderma, Rheumatoid arthritis, Scleroderma, Reagent, Software, Medical device, Vaccine, Research

The global autoimmune disease diagnostics market is projected to reach a substantial value of $9.84 billion by the year 2030, exhibiting a robust Compound Annual Growth Rate (CAGR) of 7.2% from 2023 to 2030.

Key Points: 
  • The global autoimmune disease diagnostics market is projected to reach a substantial value of $9.84 billion by the year 2030, exhibiting a robust Compound Annual Growth Rate (CAGR) of 7.2% from 2023 to 2030.
  • The growth of the autoimmune disease diagnostics market is primarily fueled by the increasing prevalence of autoimmune disorders, the growing emphasis on early diagnosis, and the rising awareness regarding autoimmune diseases.
  • Key players in the autoimmune disease diagnostics market are directing their efforts toward developing, approving, and launching kits and assays for monitoring and diagnosing autoimmune diseases.
  • The report segments the autoimmune disease diagnostics market based on product type, test type, disease type, and end-user.

Unraveling the Autoimmune Disease Diagnostics Market to 2030: Global Burden, Key Tests, and Geographic Dynamics

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星期五, 八月 25, 2023
Systemic, Prevalence, Rheumatoid factor, Abbott Laboratories, ESR, Elia, BD (company), SLE, Approximation error, Creative Diagnostics, Compound annual growth rate, Incidence, Hospital, CRP, Thermo Fisher Scientific, Investment, ANA, PerkinElmer, Autoimmune disease, Growth, Diagnosis, Mindful Scientific Inc., Systemic scleroderma, Rheumatoid arthritis, Scleroderma, Reagent, Software, Medical device, Vaccine, Research

The growth of the autoimmune disease diagnostics market is primarily fueled by the increasing prevalence of autoimmune disorders, the growing emphasis on early diagnosis, and the rising awareness regarding autoimmune diseases.

Key Points: 
  • The growth of the autoimmune disease diagnostics market is primarily fueled by the increasing prevalence of autoimmune disorders, the growing emphasis on early diagnosis, and the rising awareness regarding autoimmune diseases.
  • Key players in the autoimmune disease diagnostics market are directing their efforts toward developing, approving, and launching kits and assays for monitoring and diagnosing autoimmune diseases.
  • The report segments the autoimmune disease diagnostics market based on product type, test type, disease type, and end-user.
  • This report is an invaluable resource for stakeholders navigating the dynamic landscape of autoimmune disease diagnostics.

aTyr Pharma Announces Second Quarter 2023 Results and Provides Corporate Update

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星期三, 八月 9, 2023
International, Prevalence, Small RNA, Marketing, European Medicines Agency, Clinical trial, ILD, Medicine, Sarcoidosis, Research, Scleroderma, ERS, Committee, EMA, ATyr Pharma, Investment, Patient, SAN, European Respiratory Society, CEST, Diagnosis, Systemic scleroderma, International Congress on Tuberculosis, European Commission, Safety, Disease, D, Payment card, Pharmaceutical industry, EU

SAN DIEGO, Aug. 09, 2023 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: LIFE) (“aTyr” or the “Company”), a biotherapeutics company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced second quarter 2023 results and provided a corporate update.

Key Points: 
  • Phase 2 EFZO-CONNECT™ study of efzofitimod in SSc-ILD expected to initiate in the third quarter of 2023.
  • Ended the second quarter of 2023 with $112.0 million in cash, cash equivalents and investments.
  • SAN DIEGO, Aug. 09, 2023 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: LIFE) (“aTyr” or the “Company”), a biotherapeutics company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced second quarter 2023 results and provided a corporate update.
  • G&A Expenses: General and administrative expenses were $3.7 million for the second quarter of 2023.

European Commission Grants Orphan Drug Designation for aTyr Pharma’s Efzofitimod for Treatment of Systemic Sclerosis

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星期四, 六月 22, 2023
Inflammation, Civil service commission, Prevalence, Small RNA, Marketing, ATyr Pharma, European Medicines Agency, COMP, Neuropilin, Scar, ILD, Toxicity, Medicine, Sarcoidosis, Research, FC, Scleroderma, Biomarker, Committee, EMA, Fibrosis, Patient, SAN, Autoimmune disease, European, Biology, Diagnosis, FDA, EC, Death, Systemic scleroderma, Skin, European Commission, Safety, Disease, Pharmaceutical industry, EU

Efzofitimod is a first-in-class immunomodulator that downregulates innate immune responses in uncontrolled inflammatory disease states via selective modulation of neuropilin-2.

Key Points: 
  • Efzofitimod is a first-in-class immunomodulator that downregulates innate immune responses in uncontrolled inflammatory disease states via selective modulation of neuropilin-2.
  • “We are pleased that the EC recognizes the need for new and impactful treatments for the nearly 100,000 people living with systemic sclerosis in the European Union (EU),” said Sanjay S. Shukla, M.D., M.S., President and CEO of aTyr.
  • “This orphan drug designation takes into account more than just the rarity of the disease.
  • Efzofitimod received orphan drug and Fast Track designations for systemic sclerosis from the United States Food and Drug Administration (FDA) in 2022.

Zura Bio Completes Approximately $80 Million Financing with the Focus on Advancing ZB-106, a Potential First-in-class Anti-IL-17 and Anti-BAFF Dual Antagonist

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星期二, 六月 6, 2023
Biotechnology, Pharmaceutical, Health, Clinical Trials, Sale, HS, Inflammation, Prospectus, Patient, Hidradenitis suppurativa, Offering, Eli Lilly and Company, BAFF, Guggenheim Partners, Systemic scleroderma, Rheumatoid arthritis, Pharmaceutical industry, Security (finance), Lilly

Zura Bio Limited (Nasdaq: “ZURA”) (“Zura Bio”), a multi-asset clinical-stage biotechnology company focused on developing novel medicines for immune and inflammatory disorders, today announced the final closing of a private placement resulting in gross proceeds to Zura Bio of approximately $80 million.

Key Points: 
  • Zura Bio Limited (Nasdaq: “ZURA”) (“Zura Bio”), a multi-asset clinical-stage biotechnology company focused on developing novel medicines for immune and inflammatory disorders, today announced the final closing of a private placement resulting in gross proceeds to Zura Bio of approximately $80 million.
  • The safety profile to date appears to be acceptable, with no new findings relative to known IL-17 and BAFF inhibitors.
  • The Offering resulted in gross proceeds to Zura Bio of approximately $80 million cash, before deducting placement agent fees and other offering expenses payable by Zura Bio.
  • Zura Bio has approximately $120 million in cash and cash equivalents, which it believes will be sufficient to fund its planned operating expenses and capital expenditure requirements through 2026.