Our Pipeline
*Clearance from FDA
to start the clinical program directly by a Phase 2 study
PK MED is dedicated to developing innovative, patented, safe and effective local therapies.
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PK MED has developed a portfolio of early projects in indications with high unmet medical needs, starting with Gout flare (PKM-01), Osteoarthritis (PKM-011) and Hemoglobinopathies (PKM-02).
PKM-01
The first ever intra-articular colchicine drug product
A breakthrough treatment in gout flares
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Gout: An excruciatingly painful arthritis
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A frequent disease (more than 10 millions gout patients in the US) with
numerous comorbidities making patients difficult to treat
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Existing treatments are slow acting, poorly effective and often contraindicated
A fast acting, very effective and safe treatment
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PKM-01 is an intra-articular combination of a fast-acting anesthetic and a controlled-release form of a powerful anti-inflammatory agent (colchicine)​
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PKM-01 enables
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a fast pain relief (within minutes)
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a strong efficacy through high local drug concentration
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a favorable safety profile by limiting systemic exposure, making PKM-01 suitable for all patients
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1
Single administration per flare in all joints
5
min
Rapid onset of relief
7
days
Pain killer over the whole flare duration
Suitable for contraindicated gout patients
all
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An abbreviated and derisked development program
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505(b)(2) or hybrid application regulatory pathway
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Already known compounds with established profiles
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Clearance from FDA to initiate the clinical program directly by a Phase 2 study [Type B pre-IND meeting held on Dec. 2023]​
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Strongly supported by Key Opinion Leaders
This product will fill a much needed gap in gout flare treatments: an effective, safe alternative for all patients but mainly for those who have contraindications to other therapies"
Pr. Angelo Gaffo
Rheumatoglogist
@Birmingham VA Hospital, USA
An
encapsulated colchicine with local release represents a major advance in the management of flares"
Pr. Hang-Korng Ea
Rheumatologist
@Hopital Lariboisière
Paris, France
This new
product is a breakthrough in the treatment of gout flares. The rapid onset should improve patient - physician confidence and adherence to treatments"
Pr. M-C. Boissier
Rheumatologist @AP-HP
Paris, France
An injectable
form of colchicine as a concept is innovative and would represent a very useful
form of therapy for acute gout"
Pr. Geraldine McCarthy
Rheumatologist @University College Dublin, Ireland
PKM-011
A potential Disease Modifying OsteoArthritis Drug (DMOAD)
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A common degenerative disease affecting 500 million people worldwide (including 70 millions and 32 millions patients in Europe and in the US)
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Few pharmacological options, with major limitations in efficacy and safety
A long acting intra-articular colchicine derivated from PKM-01
PKM-02
Changing the paradigm of Hematopoïetic StemCell Transplantation (HSCT)
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Limited population eligible to HSCT
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Allogenic HSCT can cure and/or prolong life in a broad range of hematologic disorders
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About 3000-5000 allogenic HSCT/year in the US or EU​
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However, many patients are not eligible, due to limited donor matching and aggressive conditioning regimen
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PKM-02, a unique cell homing technology to enhance HSCT
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Local injection before HSCT to foster cell homing and engraftment
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Promising in-vitro results
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First indication: hemoglobinopathies
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Increase the probability of finding matched donors
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Curative treatment in adults
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Other applications in tissue regeneration