Why Gout's Straightforward Biology and Large Unmet Need Make It an Overlooked Drug Development Opportunity, says Dr James Mackay, Crystalys Therapeutics CEO

At the 2026 BIO International Convention (BIO 2026), James Mackay, PhD, co-founder, president, and CEO of Crystalys Therapeutics, spoke to BioPharm International® about the company's focus on developing a new treatment for gout, a disease he describes as widely misunderstood and significantly underserved despite its high prevalence in the United States.

According to Dr Mackay, gout is the most common form of inflammatory arthritis, affecting an estimated 15 million people in the US, which is more than rheumatoid arthritis or osteoarthritis.¹ Despite its prevalence, Dr Mackay says the condition is frequently overlooked, with many people unaware it remains a significant clinical problem. For him, the effort to develop a therapeutic for this disease at Crystalys Therapeutics is "unfinished business," having previously worked on a gout molecule at a prior company.

Why is gout an overlooked drug development target despite its high disease burden?

Dr Mackay attributes the neglect partly to public perception. Gout, he explains, is often dismissed as an outdated or minor condition. Today, the biopharmaceutical industry is expending great effort toward newer, more complex modalities. He notes, however, that the relative simplicity of gout's underlying biology is a strategic advantage, making the company’s development program easier to communicate to investors and collaborators compared with cell or gene therapy platforms.

"If there's a very significant unmet medical need, then it deserves some focus, and we should try and do something; see if we can help these patients," Dr Mackay emphasizes.

He also addresses the broader industry conversation around drug pricing, noting the importance of educating stakeholders and patients on the costs involved in drug development. He acknowledges the most-favored-nation pricing policy as a relevant industry issue, but says his fundamental focus remains on identifying and addressing unmet medical need as the core driver of the company’s work.

BIO 2026 runs June 22–25 in San Diego.

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About the speaker

James Mackay, PhD, Co-Founder, President, and CEO, Crystalys Therapeutics

Dr Mackay has more than 40 years of development and commercialization expertise in the pharmaceutical industry, including 6 drug product approvals across multiple therapeutic areas. Prior to founding Crystalys Therapeutics, he was CEO and co-founder of Aristea Therapeutics and president and CEO of Ardea Biosciences. Prior to Ardea, Dr Mackay held senior executive positions over a 30 year period at AstraZeneca where he led the development and commercialization of drugs across a range of therapy areas and managed significant global functional departments. Dr Mackay holds a Bachelor of Science in Genetics and a PhD in Medical Genetics from Aberdeen University, Scotland.

Reference

1. Dehlin M, Jacobsson L, Roddy E. Global epidemiology of gout: prevalence, incidence, treatment patterns and risk factors. Nat Rev Rheumatol. 2020;16(7):380-390. doi:10.1038/s41584-020-0441-1