Hyperuricemia

ZWI Therapeutics, Inc. Announces a Series A Financing, Two Accomplished Biopharmaceutical CEOs Join the Board of Directors, and Appointment of Chief Executive Officer

Retrieved on: 
Wednesday, January 24, 2024

Larry Miller and Ron Cohen as Independent Directors to the company's Board of Directors, and Dr. Ed Mascioli as Chief Executive Officer and Board Director.

Key Points: 
  • Larry Miller and Ron Cohen as Independent Directors to the company's Board of Directors, and Dr. Ed Mascioli as Chief Executive Officer and Board Director.
  • Ed Mascioli's significant experience leading multiple biotech companies is important in our Company's growth" said Dr. Shaoyi Jiang, the Robert Langer '70 Family and Friends Professor at Cornell University, ZWI Board member, and co-founder.
  • "As board members, Ron and Larry collectively bring decades of successful pharmaceutical industry experience to ZWI.
  • ZWI has gained meaningful guidance on CMC, non-clinical, and clinical plans from the FDA via an INTERACT meeting and is progressing toward filing an IND.

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.

U.S. Food and Drug Administration Approves Augtyro™ (repotrectinib), a Next-Generation Tyrosine Kinase Inhibitor (TKI), for the Treatment of Locally Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer (NSCLC)

Retrieved on: 
Thursday, November 16, 2023

Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Augtyro™ (repotrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).1 Administered as an oral therapy, Augtyro is a tyrosine kinase inhibitor (TKI) targeting ROS1 oncogenic fusions.1

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Augtyro™ (repotrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).1 Administered as an oral therapy, Augtyro is a tyrosine kinase inhibitor (TKI) targeting ROS1 oncogenic fusions.1
    The approval is based on the TRIDENT-1 study, an open-label, single-arm, Phase 1/2 trial that evaluated Augtyro in TKI-naïve and TKI-pretreated patients.2 In TKI-naïve patients (n=71), the primary endpoint of objective response rate (ORR), defined as the percentage of people treated within a certain period of time whose tumor size decreased (partial response) or who no longer have signs of cancer (complete response), was 79% (95% Confidence Interval [CI]: 68 to 88).1,3 The median duration of response (mDOR) was 34.1 months.
  • Among patients pretreated with one prior ROS1 TKI and no prior chemotherapy (n=56), the ORR was 38% (95% CI: 25 to 52) and the mDOR was 14.8 months.1 Among those who had measurable central nervous system (CNS) metastases at baseline, responses in intracranial lesions were observed in 7 of 8 TKI-naïve patients (n=71) and 5 of 12 of those who were TKI-pretreated (n=56).1
    “New treatment options continue to be needed for patients with ROS1 fusion-positive NSCLC that support important clinical goals, including achieving durable therapeutic responses,” said Jessica J. Lin, MD, TRIDENT-1 primary investigator and attending physician at the Center for Thoracic Cancers at Massachusetts General Hospital and Assistant Professor of Medicine at Harvard Medical School.4,5,6,7 “Based on the data we have seen in the TRIDENT-1 trial, repotrectinib has the potential to become a new standard of care option for patients with locally advanced or metastatic ROS1 fusion-positive lung cancer.”1
    Augtyro is associated with the following Warnings & Precautions: central nervous system (CNS) effects, interstitial lung disease (ILD)/pneumonitis, hepatotoxicity, myalgia with creatine phosphokinase elevation, hyperuricemia, skeletal fractures, and embryo-fetal toxicity.1 Please see Important Safety Information below.
  • “While progress has been made in the treatment of NSCLC over the past decade, there is still a need to address this particularly difficult-to-treat form of the disease with innovative science and a targeted approach,” said Samit Hirawat, MD , executive vice president, chief medical officer, Global Drug Development, Bristol Myers Squibb.6,7 “As the only approved next-generation TKI for ROS1-positive NSCLC patients, Augtyro builds on our legacy of delivering transformational therapies for patients with thoracic cancers.”6,8,9
    “ROS1-positive NSCLC patients and their families face a stressful journey because our cancer can be difficult to treat, especially when it spreads to the brain,” said Janet Freeman-Daily, co-founder and president of The ROS1ders, a patient advocacy organization.10 “Today’s approval brings a new treatment option for the ROS1-positive patient community, which gives us hope for more time with loved ones.”
    Augtyro is designed to minimize interactions that can lead to certain forms of treatment resistance in ROS1-positive metastatic NSCLC patients.6,8,11 It is expected to be available to patients in the U.S. in mid-December 2023.
  • Bristol Myers Squibb thanks the patients and investigators involved in the TRIDENT-1 clinical trial program.

XORTX Sponsored Study Presented at the American Society of Nephrology – Kidney Week 2023

Retrieved on: 
Thursday, November 2, 2023

CALGARY, Alberta, Nov. 02, 2023 (GLOBE NEWSWIRE) -- XORTX Therapeutics Inc. ("XORTX" or the “Company”) (NASDAQ: XRTX | TSXV: XRTX | Frankfurt: ANU), a late-stage clinical pharmaceutical company focused on developing innovative therapies to treat progressive kidney disease, is pleased to announce the presentation of new research findings at the American Society of Nephrology meeting being held November 3, 2023 in Philadelphia. The abstract entitled "The Effect of Lowering Uric Acid with a Xanthine Oxidase Inhibitor on PKD in Mice” was reviewed by the ASN review panel for scientific merit and novel discoveries. The studies were conducted at the University of Colorado in the independent laboratory of Dr. Charles Edelstein and were sponsored by XORTX. The studies will be presented at Kidney Week during the Session Title: Genetic Diseases: Cystic - Therapeutic Investigations and Prognosis, November 2, 2023.

Key Points: 
  • The studies were conducted at the University of Colorado in the independent laboratory of Dr. Charles Edelstein and were sponsored by XORTX.
  • The studies will be presented at Kidney Week during the Session Title: Genetic Diseases: Cystic - Therapeutic Investigations and Prognosis, November 2, 2023.
  • This poster reports amalgamated results of studies in either rat and mouse models of polycystic kidney disease (“PKD”) challenged with low to moderate circulating uric acid.
  • The effect of increased uric acid on cyst growth – kidney size - and kidney function, as well as inflammatory markers was measured.

Atom Bioscience Raises $83M in a D-Round Financing to Support Global Pivotal Clinical Trials of ABP-671, a New Treatment for Chronic Gout

Retrieved on: 
Monday, October 16, 2023

After this round of financing, Atom has raised a total of nearly $165 million.

Key Points: 
  • After this round of financing, Atom has raised a total of nearly $165 million.
  • "We appreciate the support of every investment institution involved in the D-round financing and previous investors,” said Dr. William Dongfang Shi, CEO, Chairman and Founder of Atom Bioscience.
  • Maintaining sUA levels of 5 mg/dL to 4 mg/dL in gout patients is recommended by many national gout treatment guidelines.
  • At these levels gout tophi are re-dissolved, tophi size and quantity are reduced and eventually acute gout attacks are reduced.

Atom Bioscience Doses First Patient in Phase 2b/3 Clinical Trial of a New Treatment for Chronic Gout

Retrieved on: 
Monday, October 9, 2023

Atom Bioscience (Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.), a clinical stage biotechnology company developing new treatments for inflammatory and metabolic diseases, announced today the first patient has been dosed in a Phase 2b/3 clinical trial of ABP-671, a novel orally administered URAT1 inhibitor, for the treatment of chronic gout.

Key Points: 
  • Atom Bioscience (Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.), a clinical stage biotechnology company developing new treatments for inflammatory and metabolic diseases, announced today the first patient has been dosed in a Phase 2b/3 clinical trial of ABP-671, a novel orally administered URAT1 inhibitor, for the treatment of chronic gout.
  • Part 2 of the study will be a confirmatory study for dosing regimens of ABP-671 selected from Part 1.
  • “Gout affects more than 50 million people worldwide and is on the rise in many countries,” said Atom Bioscience CEO, Chairman and Founder Dr. William Dongfang Shi.
  • At these levels gout tophi are re-dissolved, tophi size and quantity are reduced and eventually acute gout attacks are reduced.

XORTX Submits Orphan Drug Designation Application to the European Medicines Agency (EMA) to Treat Progressive Kidney Disease

Retrieved on: 
Tuesday, August 29, 2023

CALGARY, Alberta, Aug. 29, 2023 (GLOBE NEWSWIRE) -- XORTX Therapeutics Inc. (“XORTX” or the “Company”) (NASDAQ: XRTX | TSXV: XRTX | Frankfurt: ANU), a late-stage clinical pharmaceutical company focused on developing innovative therapies to treat progressive kidney disease, announces that it has submitted an Orphan Drug Designation application for XORLO™ to the European Medicines Agency (the “EMA”). The “orphan-drug designation request is for the use of XORTX’s patented unique proprietary formulation of oxypurinol – XORLO™ – for the treatment of autosomal dominant polycystic kidney disease (ADPKD)”.

Key Points: 
  • CALGARY, Alberta, Aug. 29, 2023 (GLOBE NEWSWIRE) -- XORTX Therapeutics Inc. (“XORTX” or the “Company”) (NASDAQ: XRTX | TSXV: XRTX | Frankfurt: ANU), a late-stage clinical pharmaceutical company focused on developing innovative therapies to treat progressive kidney disease, announces that it has submitted an Orphan Drug Designation application for XORLO™ to the European Medicines Agency (the “EMA”).
  • The “orphan-drug designation request is for the use of XORTX’s patented unique proprietary formulation of oxypurinol – XORLO™ – for the treatment of autosomal dominant polycystic kidney disease (ADPKD)”.
  • The orphan drug designation process (“ODD”) initiated with the submission of this application and is made to the EMA’s COMP (Committee for Orphan Medicinal Products) office.
  • It also follows on receipt of ODD status granted by the U.S. Food and Drug Administration in April 2023.

Esperion Presents Two CLEAR Outcomes Study Late-Breakers at European Society of Cardiology Congress 2023

Retrieved on: 
Saturday, August 26, 2023

ANN ARBOR, Mich., Aug. 26, 2023 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced the presentation of results from two oral presentations at the Late-Breaking Science Session entitled, “Clinical trial updates on prevention and lipid lowering” at the European Society of Cardiology (ESC) 2023 Congress, taking place August 25-28, 2023, in Amsterdam, Netherlands.

Key Points: 
  • “We are pleased to share additional results from our landmark CLEAR Outcomes study in late-breaker presentations at ESC 2023,” said Sheldon Koenig, President and CEO of Esperion.
  • Of the 13,970 patients included in CLEAR Outcomes, 45.6% had diabetes, 41.5% were pre-diabetic, and 12.9% had normoglycemia.
  • 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.

National Winners Named in the 21st Annual eCYBERMISSION STEM Competition

Retrieved on: 
Monday, July 3, 2023

Winners were announced at the National Awards Ceremony , which took place June 29.

Key Points: 
  • Winners were announced at the National Awards Ceremony , which took place June 29.
  • This year’s National Winners are:
    MISSing Monarchs raised awareness of the decline of the monarch butterfly population in their community and provided new efforts to sustain the population.
  • “The initiative of these National Winners, and of all eCYBERMISSION students, to use STEM to address real problems in their communities is a testament to that vision.
  • I offer my sincere congratulations to this year’s National Winners.”
    “Congratulations to the eCYBERMISSION National Winners.

Urica Therapeutics Announces Topline Data from the Phase 1 Clinical Trial Evaluating Dotinurad in Healthy Volunteers in the United States

Retrieved on: 
Thursday, June 29, 2023

MIAMI, June 29, 2023 (GLOBE NEWSWIRE) -- Urica Therapeutics, Inc. (“Urica” or the “Company”), a Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”) subsidiary company focused on the development and commercialization of pharmaceutical products to treat gout and other conditions associated with hyperuricemia, today announced topline data from the Phase 1 clinical trial evaluating dotinurad in healthy volunteers in the United States (“U.S.”).

Key Points: 
  • The randomized, placebo-controlled Phase 1 clinical trial evaluated the safety, tolerability, pharmacokinetics (“PK”) and pharmacodynamics (“PD”) of multiple doses of dotinurad in U.S. healthy subjects.
  • Dotinurad was shown to be safe and well tolerated with no severe adverse events observed at any dose level.
  • Pharmacodynamic data from the Phase 1 trial were also comparable to the Japanese data where over 1,000 subjects were exposed to dotinurad, including rapid and significant serum uric acid (“sUA”) reduction.
  • We are initiating a Phase 1b clinical trial in gout patients in the U.S. this summer and expect to begin pivotal clinical trials in 2024.”