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Our Pipeline

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*Clearance from FDA

to start the clinical program directly by a Phase 2 study

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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

Ancre 1

A breakthrough treatment in gout flares 

  • Gout: An excruciatingly painful arthritis 
     

  • A frequent disease (more than 10 millions gout patients in the US) with
    numerous comorbidities making patients difficult to treat
     

  • Existing treatments are slow acting, poorly effective and often contraindicated

A fast acting, very effective and safe treatment

  • PKM-01 is an intra-articular combination of a fast-acting anesthetic and a controlled-release form of a powerful anti-inflammatory agent (colchicine)​

​

  • PKM-01 enables

    • a fast pain relief (within minutes)

    • a strong efficacy through high local drug concentration 

    • a favorable safety profile by limiting systemic exposure, making PKM-01 suitable for all patients

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

  • An abbreviated and derisked development program

    • 505(b)(2) or hybrid application regulatory pathway

    • Already known compounds with established profiles

    • Clearance from FDA to initiate the clinical program directly by a Phase 2 study [Type B pre-IND meeting held on Dec. 2023]​

​

  • 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

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PKM-011

A potential Disease Modifying OsteoArthritis Drug (DMOAD)

  • A common degenerative disease affecting 500 million people worldwide (including 70 millions and 32 millions patients in Europe and in the US) 

  • 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) 

  • Limited population eligible to HSCT

    • Allogenic HSCT can cure and/or prolong life in a broad range of hematologic disorders

    • About 3000-5000 allogenic HSCT/year in the US or EU​

    • However, many patients are not eligible, due to limited donor matching and aggressive conditioning regimen

PKM-02, a unique cell homing technology to enhance HSCT

  • Local injection before HSCT to foster cell homing and engraftment 

  • Promising in-vitro results

  • First indication: hemoglobinopathies

    • Increase the probability of finding matched donors

    • Curative treatment in adults

  • Other applications in tissue regeneration

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