MACE

Ventyx Biosciences Reports Clinical Data for its NLRP3 Inhibitor Portfolio and Provides Pipeline Updates at Virtual Investor Event

Retrieved on: 
Monday, March 11, 2024

SAN DIEGO, March 11, 2024 (GLOBE NEWSWIRE) -- Ventyx Biosciences, Inc. (Nasdaq: VTYX) (“Ventyx”), a clinical-stage biopharmaceutical company focused on advancing novel oral therapies that address a broad range of inflammatory diseases with significant unmet medical need, will provide clinical and pipeline updates today during its virtual investor event.

Key Points: 
  • We believe these data support the potential for VTX3232 to emerge as a best-in-class CNS-penetrant NLRP3 inhibitor for the treatment of neuroinflammatory diseases.
  • We believe these data establish compelling clinical proof of concept for our peripheral NLRP3 inhibitor VTX2735.
  • At our virtual investor event, we will present data from the ongoing Phase 2 open-label extension.
  • Ventyx will host a virtual investor event today, Monday, March 11, 2024 from 11:00AM to 12:30PM ET.

Mesoblast Reports Financial Results and Operational Update for Half-Year Ended December 31, 2023

Retrieved on: 
Wednesday, February 28, 2024

NEW YORK, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an operational update and reported financial results for the period ended December 31, 2023.

Key Points: 
  • NEW YORK, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an operational update and reported financial results for the period ended December 31, 2023.
  • Reduction in net cash usage for operating activities:
    For the three months ended December 31, 2023, net cash usage was US$12.3 million, a 25% reduction versus the comparative quarter in FY2023.
  • For the six months ended December 31, 2023, net cash usage was US$26.6 million, a 14% reduction versus the comparative period in FY2023.
  • Manufacturing reduced by 47% for the six months ended December 31, 2023, from US$12.8 million to US$6.7 million.

Cleerly® Receives FDA Breakthrough Device Designation for Heart Disease Risk Staging System

Retrieved on: 
Tuesday, March 5, 2024

Cleerly , the company on a mission to create a new standard of care to aid in the diagnosis of heart disease, has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its Coronary Artery Disease (CAD) Staging System.

Key Points: 
  • Cleerly , the company on a mission to create a new standard of care to aid in the diagnosis of heart disease, has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its Coronary Artery Disease (CAD) Staging System.
  • The CAD Staging System is a noninvasive imaging-based investigational software device that analyzes important and actionable features of coronary atherosclerosis, stenosis and ischemia.
  • The FDA’s Breakthrough Device Designation is granted for technologies that have the possibility to encourage more effective diagnosis or treatment for life-threatening or irreversibly debilitating diseases.
  • “This designation from the FDA highlights the critical need for better heart disease risk assessment methods.

ABIONYX Pharma Acknowledges the Clinical Results of the Phase 3 AEGIS-II Study Evaluating the Efficacy and Safety of CSL Behring’s Human-plasma-derived apoA-I, CSL112

Retrieved on: 
Thursday, February 15, 2024

ABIONYX Pharma, (FR0012616852 – ABNX – PEA PME eligible), a new generation biotech company dedicated to the discovery and development of innovative therapies based on the world’s only natural recombinant apoA-I, today acknowledges that the Phase 3 AEGIS-II study evaluating the efficacy and safety of CSL Behring’s human-plasma-derived apoA-I, CSL112, compared to placebo in reducing the risk of major adverse cardiovascular events (MACE) in patients following an acute myocardial infarction (AMI), did not meet its primary efficacy endpoint of MACE reduction at 90 days.

Key Points: 
  • ABIONYX Pharma, (FR0012616852 – ABNX – PEA PME eligible), a new generation biotech company dedicated to the discovery and development of innovative therapies based on the world’s only natural recombinant apoA-I, today acknowledges that the Phase 3 AEGIS-II study evaluating the efficacy and safety of CSL Behring’s human-plasma-derived apoA-I, CSL112, compared to placebo in reducing the risk of major adverse cardiovascular events (MACE) in patients following an acute myocardial infarction (AMI), did not meet its primary efficacy endpoint of MACE reduction at 90 days.

CSL Announces Top-line Results from the Phase 3 AEGIS-II Trial Evaluating the Efficacy and Safety of CSL112 (apolipoprotein A-I [human])

Retrieved on: 
Sunday, February 11, 2024

The study did not meet its primary efficacy endpoint of MACE reduction at 90 days.

Key Points: 
  • The study did not meet its primary efficacy endpoint of MACE reduction at 90 days.
  • As a result, there are no plans for a near-term regulatory filing.
  • There were no major safety or tolerability concerns with CSL112.
  • "We will continue to analyze the findings and share the full results in the coming months."

Aclaris Therapeutics Announces Top-line Results from 4-Week Phase 2b Trial of ATI-1777 for Mild to Severe Atopic Dermatitis

Retrieved on: 
Wednesday, January 10, 2024

WAYNE, Pa., Jan. 10, 2024 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced top-line results from its Phase 2b study of ATI-1777, an investigational topical “soft” JAK 1/3 inhibitor, in patients with mild to severe atopic dermatitis (AD) (ATI-1777-AD-202; NCT05432596). ATI-1777 was generated from Aclaris’ proprietary KINect® drug discovery platform.

Key Points: 
  • For this trial, ATI-1777 was developed as an emollient-containing spray formulation.
  • The trial randomized 250 patients with mild, moderate or severe AD, including adults and children as young as 12 years old, across 30 clinical trial sites in the United States.
  • “The trial demonstrated efficacy results, a pharmacokinetic profile and safety results that were consistent with what was seen in the Phase 2a trial of ATI-1777,” stated Dr. Neal Walker, Aclaris’ Chairman of the Board of Directors.
  • These results are particularly encouraging given the higher than anticipated vehicle response and the mid-study inclusion of a milder patient population.

Tiziana Life Sciences Files New Patent Application for Combination Therapy of anti-CD3 (Foralumab) with GLP-1 Receptor Agonist for Additional Reduction of Obesity - Associated Inflammation

Retrieved on: 
Friday, January 5, 2024

Effectiveness of GLP-1ra non T2D obesity was recently shown in the >17,600 patient SELECT trial by Novo Nordisk (N Engl J Med 2023; 389:2221-2232(NCT03574597).

Key Points: 
  • Effectiveness of GLP-1ra non T2D obesity was recently shown in the >17,600 patient SELECT trial by Novo Nordisk (N Engl J Med 2023; 389:2221-2232(NCT03574597).
  • SELECT showed a 20% reduction of major adverse cardiovascular events (MACE) such as heart attack, stroke, and peripheral vascular disease, with semaglutide.
  • The risk of adverse cardiovascular events could be reduced further by the combination of intranasal foralumab and a GLP-1ra.
  • The patent application describes the potential for foralumab to provide additional risk reduction for heart attack, stroke, and peripheral vascular disease.

Altimmune Announces Positive Topline Results from MOMENTUM 48-Week Phase 2 Obesity Trial of Pemvidutide

Retrieved on: 
Thursday, November 30, 2023

GAITHERSBURG, Md., Nov. 30, 2023 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company (the “Company”), today announced topline results from its 48-week MOMENTUM Phase 2 obesity trial of pemvidutide. The trial enrolled 391 subjects with obesity or overweight with at least one co-morbidity and without diabetes. Subjects were randomized 1:1:1:1 to 1.2 mg, 1.8 mg, 2.4 mg pemvidutide or placebo administered weekly for 48 weeks in conjunction with diet and exercise. The 1.2 mg and 1.8 mg doses were administered without dose titration, while a short 4-week titration period was employed for the 2.4 mg dose. At baseline, subjects had a mean age of approximately 50 years, mean body mass index (BMI) of approximately 37 kg/m2 and mean body weight of approximately 104 kg. Approximately 75% of subjects were female.

Key Points: 
  • The trial enrolled 391 subjects with obesity or overweight with at least one co-morbidity and without diabetes.
  • Subjects were randomized 1:1:1:1 to 1.2 mg, 1.8 mg, 2.4 mg pemvidutide or placebo administered weekly for 48 weeks in conjunction with diet and exercise.
  • More subjects receiving pemvidutide stayed on study compared to those receiving placebo, with 74.1% of pemvidutide subjects completing the trial compared to 61.9% of placebo subjects.
  • If approved, we believe pemvidutide could offer an important option for obesity patients, including those with risk factors for cardiovascular disease.”

FIBROGEN ALERT: Bragar Eagel & Squire, P.C. is Investigating FibroGen, Inc. on Behalf of Long-Term Stockholders and Encourages Investors to Contact the Firm

Retrieved on: 
Wednesday, December 27, 2023

Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, is investigating potential claims against FibroGen, Inc. (NASDAQ: FGEN) on behalf of long-term stockholders following a class action complaint that was filed against FibroGen on April 12, 2021 with a Class Period from December 20, 2018 to July 15, 2021.

Key Points: 
  • Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, is investigating potential claims against FibroGen, Inc. (NASDAQ: FGEN) on behalf of long-term stockholders following a class action complaint that was filed against FibroGen on April 12, 2021 with a Class Period from December 20, 2018 to July 15, 2021.
  • Our investigation concerns whether the board of directors of FibroGen have breached their fiduciary duties to the company.
  • On this news, the Company's share price fell $14.90, or 43%, to close at $19.74 per share on April 7, 2021, on heavy volume.
  • There is no cost or obligation to you.

Esperion Presents CLEAR Outcomes Analysis of Inflammation as Predictor of Cardiovascular Risk at American Heart Association Scientific Sessions 2023

Retrieved on: 
Monday, November 13, 2023

ANN ARBOR, Mich., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced the presentation of results from a pre-specified, exploratory analysis of CLEAR Outcomes at the 2023 American Heart Association (AHA) Scientific Sessions. Results were also simultaneously published in Circulation which can be accessed here.

Key Points: 
  • “In the future, it can be anticipated that virtually all atherosclerosis patients will receive aggressive inflammation inhibition along with aggressive cholesterol reduction,” Ridker added.
  • In CLEAR Outcomes, patients who were randomized to bempedoic acid experienced a 21.6% reduction in hsCRP compared to placebo at 6 months.
  • At Esperion, we discover, develop, and commercialize innovative medicines to help improve outcomes for patients with or at risk for cardiovascular and cardiometabolic diseases.
  • CLEAR Outcomes is part of the CLEAR clinical research program for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet.