URAT1

Atom Bioscience Receives FDA IND Clearance for Clinical Trial of ABP-745 for Acute Gout

Retrieved on: 
Tuesday, January 2, 2024

Atom Bioscience (Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.), a clinical stage biotechnology company developing best-in-class treatments for inflammatory and metabolic diseases, announced today the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for a Phase 1 clinical trial of ABP-745, an anti-inflammatory oral small molecule drug, for the treatment of acute gout.

Key Points: 
  • Atom Bioscience (Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.), a clinical stage biotechnology company developing best-in-class treatments for inflammatory and metabolic diseases, announced today the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for a Phase 1 clinical trial of ABP-745, an anti-inflammatory oral small molecule drug, for the treatment of acute gout.
  • Atom also has submitted an IND application for a Phase 1 clinical of ABP-745 in China.
  • Dr. William Dongfang Shi, Founder, Chairman and CEO of Atom Biosciences, said, “The IND clearance of ABP-745 is important progress in the anti-inflammatory research field of Atom Bioscience’s clinical development.
  • We expect to begin the Phase 1 trial for acute gout in the U.S. soon.

Latest Updates of Viva's Portfolio Companies

Retrieved on: 
Monday, December 4, 2023

TORONTO & WALTHAM, Mass.--(BUSINESS WIRE)--On Nov. 29th, Phenomic AI ("Phenomic"), invested and incubated by Viva BioInnovator (VBI), announced that they have entered into a strategic collaboration and licensing agreement with Boehringer Ingelheim to discover targets important in stroma-rich cancers. The partners will leverage Phenomic's expertise in target identification and stromal biology based on its scTx® single-cell transcriptomics platform which will greatly enhance Boehringer's efforts to develop first-in-class medicines to transform the lives of people with cancer by delivering meaningful advances with the ultimate goal to cure a range of cancers. Phenomic will receive upfront and near-term payments of approximately $9 million including research funding and collaboration milestones. Phenomic is also eligible to receive more than USD $500 million in licensing fees as well as clinical, regulatory and commercial milestones in addition to royalties on future product sales.

Key Points: 
  • HONG KONG, Dec. 4, 2023 /PRNewswire/ -- Even with the ever-changing situation, technological innovation is still the most critical component for biopharmaceutical companies' long-term development.
  • This continuous innovation keeps companies up to date and promotes the evolution of R&D and the success of commercialization.
  • Recently, Viva's portfolio companies have new updates.
  • Phenomic will receive upfront and near-term payments of approximately $9 million including research funding and collaboration milestones.

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.

Arthrosi Announces Multiple Presentations at the American College of Rheumatology (ACR) Convergence 2023

Retrieved on: 
Monday, October 16, 2023

SAN DIEGO, Oct. 16, 2023 /PRNewswire/ -- Arthrosi Therapeutics, Inc., a clinical-stage biotechnology company developing treatments to reduce uric acid levels, dissolve uric acid crystals and prevent joint damage in gout patients, today announced the acceptance of three poster presentations and one late breaking oral presentation at the American College of Rheumatology (ACR) Convergence 2023 meeting, being held in San Diego, CA on November 10-15, 2023.

Key Points: 
  • SAN DIEGO, Oct. 16, 2023 /PRNewswire/ -- Arthrosi Therapeutics, Inc., a clinical-stage biotechnology company developing treatments to reduce uric acid levels, dissolve uric acid crystals and prevent joint damage in gout patients, today announced the acceptance of three poster presentations and one late breaking oral presentation at the American College of Rheumatology (ACR) Convergence 2023 meeting, being held in San Diego, CA on November 10-15, 2023.
  • Details for the presentations are as follows:
    Title: AR882, an Efficacious and Selective URAT1 Inhibitor for Patients with Chronic Gouty Arthritis and Subcutaneous Tophi: Results from a Global, Prospective, Proof-of-Concept Trial Using Dual Energy Computed Tomography
    Title: Efficacy and Safety of AR882, a Selective Uric Acid Transporter 1 (URAT1) Inhibitor, in Gout Patients with Various Baseline Characteristics Following 12-Week Treatment in Patients

Latest Updates of 7 Viva's Portfolio Companies

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Friday, July 28, 2023

WATERTOWN, Mass.-- Riparian Pharmaceuticals, a Viva Biotech portfolio company, is a biotechnology company focused on discovering novel therapeutics for cardiovascular diseases. Riparian today announced it has entered into an exclusive license agreement and research agreement with Pfizer.

Key Points: 
  • WATERTOWN, Mass.-- Riparian Pharmaceuticals, a Viva Biotech portfolio company, is a biotechnology company focused on discovering novel therapeutics for cardiovascular diseases.
  • Riparian today announced it has entered into an exclusive license agreement and research agreement with Pfizer.
  • In exchange for exclusive rights to a Riparian preclinical program, Pfizer will make upfront and milestone payments, as well as pay royalties on sales of resulting therapeutics.
  • DTx Pharma utilizes its groundbreaking FALCON™ platform, a conjugated oligonucleotide technology using fatty acid ligands, to tackle the delivery challenges of oligonucleotide therapies.

Atom Bioscience Announces Positive Results of Phase 2a China Clinical Trial of Its URAT1 Inhibitor for Chronic Gout

Retrieved on: 
Wednesday, March 1, 2023

Atom Bioscience (Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.), a clinical stage biotechnology company developing best in class treatments for inflammatory and metabolic diseases, announced today positive results from its China Phase 2a clinical trial of ABP-671.

Key Points: 
  • Atom Bioscience (Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.), a clinical stage biotechnology company developing best in class treatments for inflammatory and metabolic diseases, announced today positive results from its China Phase 2a clinical trial of ABP-671.
  • The randomized, double-blind, placebo-controlled trial enrolled 54 patients with gout or hyperuricemia across six cohorts, with 7 randomized to ABP-671 and 2 to placebo per cohort.
  • At a dose of 1 mg ABP-671 once daily (QD), 86% of patients reached serum uric acid (sUA) levels below 6 mg/dL.
  • The Phase 2a Australian study met its primary objective of lowering sUA levels to below 6 mg/dL and was well tolerated.

Urica Therapeutics Expands Exclusive License Agreement with Fuji Yakuhin Co. Ltd. to Develop Dotinurad in Additional Territories Including Turkey and the Middle East and North Africa

Retrieved on: 
Wednesday, December 14, 2022

The agreement builds upon the exclusive license agreement between Urica and Fuji previously announced in May of 2021 to develop dotinurad in the United States (“US”), United Kingdom, European Union and Canada.

Key Points: 
  • The agreement builds upon the exclusive license agreement between Urica and Fuji previously announced in May of 2021 to develop dotinurad in the United States (“US”), United Kingdom, European Union and Canada.
  • Under the terms of the agreement, the Company acquired exclusive development and marketing rights in MENA and Turkey from Fuji.
  • In May 2021, Fortress announced an exclusive license agreement between its subsidiary, Urica Therapeutics, Inc. (formerly UR-1 Therapeutics, Inc.), and Fuji Yakuhin Co. Ltd. to develop dotinurad in North America and Europe.
  • In November 2022, Urica licensed rights to dotinurad from Fuji for additional territories including MENA and Turkey.

Atom Bioscience to Present Final Data from its Positive Phase 2a Clinical Trial in Chronic Gout at American College of Rheumatology Annual Meeting, Nov. 10 – 14, in Philadelphia, PA

Retrieved on: 
Thursday, November 10, 2022

Mean sUA levels for all three APB-671 dose groups met the primary endpoint of less than 6 mg/dL.

Key Points: 
  • Mean sUA levels for all three APB-671 dose groups met the primary endpoint of less than 6 mg/dL.
  • The final data demonstrates the breadth of sUA reductions observed in the clinical trial.
  • This is a major step forward for the control of chronic gout, said Atom CEO, Chairman, and Founder Dr. William Shi.
  • The companys lead product, ABP-671, is in late stage clinical development for treatment of chronic gout.

Fortress Biotech Announces First Patient Dosed in Phase 1 Clinical Trial Evaluating Dotinurad for the Treatment of Gout in the United States

Retrieved on: 
Tuesday, May 31, 2022

MIAMI, May 31, 2022 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (NASDAQ: FBIO) (“Fortress”), an innovative biopharmaceutical company focused on efficiently acquiring, developing and commercializing or monetizing promising therapeutic products and product candidates, today announced that its subsidiary company, UR-1 Therapeutics, Inc. (“UR-1”), dosed the first patient in a Phase 1 clinical trial evaluating Dotinurad for the treatment of gout in the United States.

Key Points: 
  • The principal objective of this Phase 1 clinical trial is to study the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of Dotinurad in Western subjects.
  • Subjects will be randomized into a placebo-controlled crossover clinical trial design to evaluate a wide range of Dotinurad doses.
  • Dotinurad was efficacious and well-tolerated in more than 500 Japanese patients treated for up to 58 weeks in Phase 3 clinical trials.
  • Dotinurad has been approved to treat gout and hyperuricemia in Japan and is currently in a Phase 1 clinical trial in the United States.