France-based biotechnology company PK Med has received clearance from the US Food and Drug Administration (FDA) to advance its injectable gout treatment PKM-01 into Phase II clinical trials, without undergoing Phase I studies. 

The Phase II trial will evaluate three doses of PKM-01, a combined treatment of controlled-release colchicine with ropivacaine, an anaesthetic. The prospective, randomised study aims to select the optimal dose of the treatment to further advance it into Phase III trials. 

PKM-01 is an intra-articular injectable treatment candidate for gout flares. Unlike current treatment regimens, ropivacaine’s anaesthetic effect is expected to alleviate pain within minutes of injection. Oral colchicine, a standard anti-inflammatory treatment for gout, can only be used in low doses due to toxicity and systemic exposure. PKM-01’s localised colchicine delivery aims to offer potent, lasting pain and inflammation relief without the systemic risks associated with standard-of-care treatments. 

Gout is a type of arthritis that occurs when there is a buildup of uric acid in the body, leading to the formation of urate crystals in the joints. This can cause sudden and severe pain, swelling, and inflammation – typically in the big toe but can affect other joints as well.  

According to a report on GlobalData’s Pharmaceutical Intelligence Center, the number of diagnosed prevalent cases of gout is predicted to be 25,961,819 in 2032. The gout market is forecast to be worth $10.77bn in 2032, an increase from $4.63bn in 2022. 

GlobalData is the parent company of Pharmaceutical Technology.

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There are several therapies in the late-stage pipeline for gout, most of which are urate-lowering therapies or anti-inflammatory therapies, one of which being Dapansutrile, an inflammasome inhibitor forecast to launch in 2026 – potentially offering an improved safety profile for long-term use compared to the current treatment regimen of nonsteroidal anti-inflammatory drugs, corticosteroids, and colchicine, as per a GlobalData analyst. 

In the 26 February announcement accompanying the FDA clearance, PK Med CEO Gauthier Pouliquen said: “This FDA feedback is excellent news for clinicians and patients suffering from gout flares. It should significantly accelerate the time-to-market for PKM-01. PK MED is now entering the fund-raising phase to finance PKM-01 Phase II clinical trials. With robust patent protection and a clear path to deliver Phase II results, PKM-01 represents an attractive and low-risk opportunity for investors and partners.”