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FDA clears PK Med to streamline gout injectable to Phase II

2024-02-26

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The number of diagnosed prevalent cases of gout will be 25,961,819 in 2032, according to GlobalData. Credit: ThamKC via Shutterstock.

France-based biotechnology company PK Med hgouteceived 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 thPK Medses of PKM-01, a combined treatment Food and Drug Administration (FDA)ith ropivacaine, an anaesthgout. The prospPKM-01, 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 treatmenPKM-01idate for gout flares. Unlike current treatmecolchicines, ropropivacaineanaesthetic 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.

PKM-01s a type of arthritis that occurs when there is a buildup goutric acid in the body, leading to the formatiropivacaine crystals in the joints. This can cause sudden painsevere pain, swelling, and inflammacolchicineically in the big toe but can affect other jogout as well.PKM-01 colchicine pain inflammation

Goutrding to a reparthritisobalData’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 fpainasswellingworth inflammation2032, an increase from $4.63bn in 2022.

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GlobalData is the parent company of Pharmaceutical Technology.

FDAre are sevAlvotechrapies 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.”

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