Systemic scleroderma

aTyr Pharma Announces Commencement of Public Offering of Common Stock

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星期三, 二月 8, 2023
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In addition, aTyr expects to grant the underwriters a 30-day option to purchase additional shares of its common stock in an amount up to an additional 15% of the shares sold in the public offering.

Key Points: 
  • In addition, aTyr expects to grant the underwriters a 30-day option to purchase additional shares of its common stock in an amount up to an additional 15% of the shares sold in the public offering.
  • All of the shares to be sold in the offering are to be sold by aTyr.
  • The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering.
  • These forward-looking statements include statements regarding the timing, terms and completion of the proposed public offering and anticipated use of proceeds from the offering.

Emerald Health Pharmaceuticals Receives Safety Review Committee Approval to Proceed to Final Cohorts of EHP-101 Phase 2a Systemic Sclerosis Trial

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星期三, 一月 11, 2023
Emerald, Disease, Pharmacokinetics, Safety, FDA, Skin, SRC, Plasma, Patient, Physician, Fibrosis, SAN, Pharming, Systemic scleroderma, Scleroderma, EHP, Pharmaceutical industry

The SRC is comprised of two physicians, one independent and the other the principal investigator in the trial.

Key Points: 
  • The SRC is comprised of two physicians, one independent and the other the principal investigator in the trial.
  • This SSc Phase 2a trial is a double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of EHP-101 in patients with SSc.
  • EHP has completed the first two cohorts, each with nine SSc patients, administering two doses either once daily or twice daily.
  • The Company applied for this amendment to create a pathway to possibly advance directly into a Phase 3 clinical trial of EHP-101 in patients suffering from SSc once the Phase 2a trial is completed, rather than first conducting a Phase 2b before continuing to a Phase 3 trial.

Chemomab Reports Top-Line Results from CM-101 Phase 2a Liver Fibrosis Biomarker Trial in NASH Patients

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星期二, 一月 3, 2023
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TEL AVIV, Israel, Jan. 3, 2023 /PRNewswire/ -- Chemomab Therapeutics, Ltd. (Nasdaq: CMMB) (Chemomab), a clinical-stage biotechnology company focused on the discovery and development of innovative therapeutics for fibrotic and inflammatory diseases with high unmet need, today reported top-line results from its Phase 2a trial assessing CM-101, its first-in-class CCL24-neutralizing monoclonal antibody, in non-alcoholic steatohepatitis (NASH) patients. The trial met its primary endpoint of safety and tolerability, and CM-101 achieved reductions in secondary endpoints that include a range of liver fibrosis biomarkers and physiologic assessments measured at baseline and at week 20.

Key Points: 
  • The randomized, placebo-controlled trial enrolled 23 NASH patients with stage F1c, F2 and F3 disease who were randomized to receive either CM-101 or placebo.
  • Dr. Pfost continued, "This is the third clinical trial in patients demonstrating the activity of CM-101 as measured by fibro-inflammatory biomarkers and physiological assessments.
  • A Phase 2 liver fibrosis biomarker study in NASH patients was recently completed and a Phase 2 trial in primary sclerosing cholangitis patients is ongoing.
  • Chemomab expects to begin enrolling patients in a Phase 2 trial in systemic sclerosis early in 2023.

aTyr Pharma Announces Third Quarter 2022 Results and Provides Corporate Update

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星期四, 十一月 10, 2022
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SAN DIEGO, Nov. 10, 2022 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced third quarter 2022 results and provided a corporate update.

Key Points: 
  • Ended the third quarter 2022 with $79.6 million in cash, restricted cash, cash equivalents and investments.
  • SAN DIEGO, Nov. 10, 2022 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced third quarter 2022 results and provided a corporate update.
  • Announced the publication of results of the Phase 1b/2a study of efzofitimod in patients with pulmonary sarcoidosis in the peer-reviewed medical journal CHEST.
  • G&A Expenses: General and administrative expenses were $3.6 million for the third quarter of 2022.

Chemomab Presents Clinical Data from Investigator-Initiated Study Showing CM-101 Reduced Inflammatory and Fibrogenesis-Related Biomarkers in Patients with Severe Lung Injury Derived from Covid-19

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星期三, 十一月 9, 2022
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TEL AVIV, Israel, Nov. 9, 2022 /PRNewswire/ -- Chemomab Therapeutics, Ltd. (Nasdaq: CMMB) (Chemomab), a clinical-stage biotechnology company focused on the discovery and development of innovative therapeutics for fibrotic and inflammatory diseases with high unmet need, announced that clinical data presented today showed that CM-101 was safe and well-tolerated and achieved reductions in biomarkers associated with lung inflammation and fibrogenesis in a clinical study in patients hospitalized with COVID-19-derived lung injury. CM-101 is a first-in-class monoclonal antibody that neutralizes CCL24, a soluble protein with pro-fibrotic and pro-inflammatory effects. It is in development for the treatment of fibro-inflammatory disorders, including primary sclerosingcholangitis (PSC) and systemic sclerosis (SSc).

Key Points: 
  • The presentation, Treatment with CM-101 Reduced Inflammatory & Fibrotic Biomarkers in Patients with COVID-19-Derived Lung Damage, was discussed by Chemomab co-founder and Chief Scientific Officer Dr. Adi Mor at the Union World Conference on Lung Health 2022.
  • The objective of the study was to evaluate the drug's safety and activity in hospitalized COVID-19 patients with severe pneumonia, including its impact on biomarkers related to lung inflammation that are also relevant in systemic sclerosis.
  • The open label, single arm trial enrolled 16 adult COVID-19 patients with severe respiratory involvement.
  • CM-101 exposures and target engagement profiles were similar to what Chemomab researchers have seen in previous clinical studies of CM-101.

Emerald Health Pharmaceuticals Reports Data Showing Novel Drug Candidate is First-in-class B55α/PP2A Activator

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星期四, 十月 13, 2022
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SAN DIEGO, CA, Oct. 13, 2022 (GLOBE NEWSWIRE) -- Emerald Health Pharmaceuticals Inc. (“EHP” or the “Company”), a clinical-stage biopharmaceutical company developing a new class of medicines to treat neurodegenerative, autoimmune and other diseases, today announced the publication of a scientific article in the peer-reviewed Journal of Neuroinflammation highlighting additional data supporting the unique mechanism of action of EHP-101, the company’s first-in-class drug candidate for the treatment of systemic sclerosis (SSc) and multiple sclerosis (MS).

Key Points: 
  • This first-in-class activator of the HIF pathway via modulation of B55a provides a new mechanism to treat diseases where vascular integrity is compromised.
  • About Emerald Health Pharmaceuticals Inc.
    Emerald Health Pharmaceuticals is developing novel product candidates for the treatment of CNS, autoimmune, and other diseases.
  • The Companys second product candidate, EHP-102, is in non-clinical development withIND-enabling studiesand is focused on treating Parkinsons disease and Huntingtons disease.
  • Emerald Health Pharmaceuticals' investigational drug products have not been approved or cleared by the FDA

Emerald Health Pharmaceuticals Completes Enrollment of First Two Cohorts of Phase II Systemic Sclerosis Trial

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星期五, 十月 7, 2022
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This study is assessing the effectiveness of EHP-101 in treating patients suffering from systemic sclerosis (SSc).

Key Points: 
  • This study is assessing the effectiveness of EHP-101 in treating patients suffering from systemic sclerosis (SSc).
  • This SSc Phase 2a trial is a double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy in patients with SSc.
  • We look forward to evaluating the interim analysis of the first two cohorts of this Phase 2 trial in early 2023.
  • Emerald Health Pharmaceuticals' investigational drug products have not been approved or cleared by the FDA

aTyr Pharma to Participate in RBC Biotech Expert Insights: Pulmonary/Lung Disease Mini-Symposium

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星期二, 十月 4, 2022
Degenerative disease, Biology, ATyr Pharma, Research, KOL, Scleroderma, Sarcoidosis, Systemic scleroderma, RNA transfection, SAN, LIFE, RBC, GLOBE, Pharmaceutical industry

Details of the presentation appear below:

Key Points: 
  • Details of the presentation appear below:
    The Mini-Symposium will include a series of company presentations and Key Opinion Leader (KOL) sessions in the area of pulmonary/lung disease.
  • Planned KOL interviews include physician experts in pulmonary sarcoidosis and systemic sclerosis (SSc, also known as scleroderma)-associated interstitial lung disease, among other disease indications.
  • To attend the KOL sessions, investors may contact their RBC sales representative to register.
  • aTyr is a biotherapeutics company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform.

aTyr Pharma Receives FDA Fast Track Designation for Efzofitimod for Treatment of Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD)

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星期二, 九月 13, 2022
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SAN DIEGO, Sept. 13, 2022 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: LIFE), a clinical stage biotherapeutics company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced that the U.S. Food and Drug Administration (FDA) has granted the company Fast Track designation for its lead therapeutic candidate, efzofitimod, for the treatment of systemic sclerosis (SSc, also known as scleroderma)-associated, interstitial lung disease (ILD).

Key Points: 
  • Efzofitimod is a first-in-class immunomodulator that downregulates innate and adaptive immune responses in uncontrolled inflammatory disease states via selective modulation of neuropilin-2 (NRP2).
  • We believe this designation further validates efzofitimod and greatly expands the market potential for this first-in-class therapeutic.
  • aTyr is developing efzofitimod as a potential therapeutic for patients with fibrotic lung disease.
  • aTyrs lead indication for efzofitimod is pulmonary sarcoidosis, a major form of interstitial lung disease.

Simulations Plus Releases State-of-the-Art QSP Software for Interstitial Lung Disease

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星期三, 八月 31, 2022
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Simulations Plus , Inc. (Nasdaq: SLP), a leading provider of modeling and simulation software and services for pharmaceutical safety and efficacy, today announced that its DILIsym Services (DSS) division has released ILDsym version 1A, quantitative systems pharmacology (QSP) modeling software.

Key Points: 
  • Simulations Plus , Inc. (Nasdaq: SLP), a leading provider of modeling and simulation software and services for pharmaceutical safety and efficacy, today announced that its DILIsym Services (DSS) division has released ILDsym version 1A, quantitative systems pharmacology (QSP) modeling software.
  • Dr. Lisl Shoda , associate vice president, added: Interstitial lung disease significantly worsens the prognosis for patients with SSc and increases their healthcare costs by roughly 50%.
  • ILDsym and our scientific consulting expertise are positioned to support our clients in the development of novel treatments for SScILD.
  • Serving clients worldwide for more than 25 years, Simulations Plus is a leading provider in the biosimulation market providing software and consulting services supporting drug discovery, development, research, and regulatory submissions.