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Gout has become the “fourth highest disease”. Can it become the next tens of billions market for innovative drugs?

Gout, a prevalent and complex form of arthritis, can affect individuals of all ages, with a higher incidence in males than females. Characterized by sudden joint pain, swelling, redness, and inflammation, gout often strikes at night and can last for days or weeks.

According to a report by Huan An Securities, hyperuricemia, a high level of uric acid in the blood, has become the “fourth highest” health concern. The global prevalence of gout and hyperuricemia is on the rise, with a noticeable trend towards younger patients. Hyperuricemia is the primary cause of gout, with global incidence ranging from 2.6% to 36%, while gout affects 0.03% to 15.3% of the population.

Frost & Sullivan estimates that, as of 2020, the worldwide number of individuals suffering from hyperuricemia and gout is approximately 930 million.

In the face of this increasing prevalence, what is the current status of drug development for gout? But before delving into that, let’s understand the causes of gout.

Causes of Gout:

Gout is a crystal-related joint disease caused by the deposition of monosodium urate crystals. Its onset is related to the concentration of uric acid in the body, leading to the formation of urate crystal deposits in joint spaces, triggering acute joint pain. Gout encompasses acute attacks, formation of gouty crystals, chronic gouty arthritis, urate nephropathy, uric acid urinary stones, joint disability, and renal failure.

The main trigger for gout is the consumption of foods rich in purines. Currently, gout management involves two primary approaches: pharmaceutical treatment and dietary adjustments.

Pharmaceutical treatments for gout include non-steroidal anti-inflammatory drugs (NSAIDs) and corticosteroids, though their usage is limited. Dietary strategies commonly involve reducing the intake of high-purine and high-fat foods, such as meats, game, seafood, yeast-containing foods, and beverages, while increasing the consumption of low-purine foods to facilitate uric acid elimination through urine.

Now, let’s explore the existing medications used in the treatment of gout.

Current Medications:

Gout presents certain clinical challenges, notably a significant need for early education, and there is currently no curative drug for primary gout. Existing treatment medications generally pose safety concerns.

During acute episodes, anti-inflammatory drugs such as NSAIDs and colchicine are the first-line treatments. For recurrent or chronic gout, first-line treatment involves urate-lowering medications, mainly xanthine oxidase (XO) inhibitors like allopurinol and febuxostat, and drugs promoting renal excretion of uric acid, such as probenecid.

Secondary treatment options include uric acid-decomposing drugs like pegloticase and IL-1 antagonists.

However, existing gout medications carry certain safety risks. Allopurinol may cause skin allergies and liver or kidney damage, febuxostat may increase the risk of heart attacks and severe liver damage, and probenecid may pose a risk of acute hepatitis.

According to statistics from relevant organizations, in 2021, febuxostat, pegloticase, and allopurinol were the top three best-selling drugs in the global anti-gout drug market, accounting for 33%,25%, and 17% of sales, respectively.

Despite the vast market size, currently available drugs do not fully meet clinical needs in terms of safety and efficacy. Gout patients are expressing a strong demand for new, safer uric acid excretion-promoting drugs.

Ongoing Research on New Drugs:

Globally, there are 147 clinical-stage drugs for hyperuricemia and gouty arthritis, with 43 already on the market. Among them,18 have indications for hyperuricemia, including 4 combination drugs. One drug is awaiting market approval,13 are in phase III clinical trials,7 are in phase II/III clinical trials, and 21 are in phase II clinical trials.

URAT1 is the most researched target for anti-gout drugs, with 37 URAT1 projects worldwide, including combination drugs.

Several pharmaceutical companies are in the forefront of URAT1 research. Preliminary phase II clinical data shows excellent results for biologics lowering uric acid, with some drugs exhibiting the potential to dissolve gouty crystals.

From existing clinical data, it is evident that drugs under research for hyperuricemia and gout are showing promising trends. It is anticipated that gout will cease to be a significant concern for many in the near future.

References

[1]Xinhua News

[2]Southwest Securities

[3]Huan An Securities

[4] Various Company Websites

[5]Baidu Baike

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