Crystalys Therapeutics Appoints Former Horizon CEO Tim Walbert to Board as Gout Drug Advances Through Phase 3 Trials
Key Insights
Crystalys Therapeutics (search) has appointed Tim Walbert, former CEO of Horizon Therapeutics (search), as an independent board director to provide commercial leadership expertise.
Walbert brings significant experience in gout therapeutics and led Horizon's transformation into a rare disease leader before its $28 billion acquisition by Amgen.
The appointment comes as Crystalys advances dotinurad, a next-generation URAT1 (search) inhibitor, through global Phase 3 registration trials for gout treatment.
Crystalys Therapeutics (search) announced the appointment of Tim Walbert, former Chairman, President and CEO of Horizon Therapeutics (search), as an independent board director. The clinical-stage biopharmaceutical company, which focuses on addressing unmet medical needs in gout treatment, made the announcement as it advances its lead candidate dotinurad through global Phase 3 registration trials.
Strategic Leadership Addition
Walbert brings extensive biopharmaceutical industry experience, having led Horizon Therapeutics (search) from 2008 to 2023 through its transformation into a leading rare-disease biopharmaceutical organization. Under his leadership, Horizon was acquired by Amgen in a transaction valued at approximately $28 billion. His career also includes serving as President, CEO and Director of IDM Pharma Inc., which was acquired by Takeda (search), and senior commercial leadership roles at NeoPharm Inc. and Abbott (now AbbVie (search)), where he led the global development and launch of HUMIRA across multiple indications.
"We are delighted to welcome Tim to our Board of Directors at this exciting time for the company," said BT Slingsby, M.D., Ph.D., M.P.H, Co-Founder and Chairman of Crystalys Therapeutics (search). "With his extensive industry experience and recent commercial leadership in the gout space, Tim brings a valuable perspective that will complement our scientific and clinical expertise and help guide the company as we advance our two Phase 3 registration trials and prepare for commercialization."
Dotinurad Development Program
Crystalys is developing dotinurad, a next-generation, once-daily oral URAT1 (search) inhibitor designed as a second-line therapy for reducing uric acid levels, gout flares and tophi. The compound was invented by Fuji Yakuhin (search) and has obtained regulatory approval in Japan, China, Philippines and Thailand. The drug is supported by clinical data from multiple Asian markets where it has received approval.
"Tim's experience developing and commercializing medicines along with his significant experience in the gout disease area will be highly relevant as we advance dotinurad through global Phase 3 development and prepare for the next stages of execution," said James M. Mackay, Ph.D., Co-Founder, Chief Executive Officer and President of Crystalys Therapeutics (search).
Addressing Treatment Gaps in Gout
Gout represents the most common form of inflammatory arthritis, characterized by sudden, severe attacks of pain, swelling, redness and tenderness in joints. The condition arises from excess uric acid in the body, known as hyperuricemia, which causes buildup of uric acid crystals and inflammation, leading to tophaceous gout in people with chronic or undertreated disease.
Despite available therapies that aim to reduce uric acid levels below the target 6 mg/dL, a major treatment gap exists between first-line xanthine oxidase inhibitors (XOIs) and last-line uricase therapy. Currently, no suitable second-line options exist in the U.S. or E.U., creating a critical unmet need for patients who fail to respond to first-line treatments.
Company Background
Crystalys Therapeutics (search) is headquartered in San Diego, California, and was co-founded by Catalys Pacific (search) and Novo Holdings (search). The company has assembled a team with expertise in gout drug development, focusing on delivering more effective treatment options for people living with gout. Dotinurad is positioned as having best-in-class potential for both safety and efficacy as the company advances toward regulatory approval and commercial launch.