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Clinical trial updates

MWTX-003

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  • Product Information

    Product Information

    Scientific name: MWTX-003
    Brand name: DISC-3405
    RESPONSIBLE: Disc Medicine Inc and Mabwell Therapeutics

  • Clinical Trial/Study Information

    Clinical Trial/Study Information

    Trial Name: N/A
    Code: NCT06050915 
    Phase: 1 (Proof-of Mechanism)
    Eligible patient diagnosis: Healthy Volunteers
    No. of Patients enrolled: 64 [anticipated] (Last update: 20/12/2023)
    Study Sites: 1 Sites per country

    Anticipated completion date: 2024
    Scope of the Study / Aim: Targets TMPRSS6 with an antibody to enable the increase of hepcidin and reduction of iron

  • Regulatory Information

    Regulatory Information

    Status: Not Authorised

    Additional notable points:

    • EMA: N/A
    • FDA: Received acceptance of an Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) in November 2022.
    • MHRA: N/A

Update: 19 December 2024

New data

  • Data presented at the 66th ASH Annual Congress (7 – 10 December 2024) in San Diego (USA):
    • Preliminary findings in healthy volunteers in both single ascending dose (SAD) and multiple ascending dose (MAD) groups showed meaningful and sustained serum iron reductions, a safe and tolerable profile and no serious adverse events.
    • These results support Disc’s plans to advance the DISC-3405 program into a Phase 2 study in polycythemia vera in 2025.

Sources:
Phase 1 Healthy Volunteer Study of DISC-3405, a Recombinant Humanized Antibody Targeting TMPRSS6
https://ir.discmedicine.com/news-releases/news-release-details/disc-medicine-presents-positive-clinical-and-translational-data

 

Update: 30 September 2024

Data from multiple ascending doses expected by the end of the year.

Source: https://ir.discmedicine.com/news-releases/news-release-details/disc-medicine-reports-second-quarter-2024-financial-results-and

 

Update: 30 June 2024

  • Data presented at the 29th EHA Annual Congress (13 – 16 June 2024) in Madrid (Spain) showed that the Phase 1 trial in healthy volunteers demonstrated >50% serum iron suppression and sustained hepcidin induction, thus demonstrating clinical proof-of-mechanism as an iron restriction agent.

Source: https://www.stocktitan.net/news/IRON/disc-medicine-presents-positive-clinical-data-across-portfolio-at-7o4rwuahev00.html

 

Update: 31 March 2024

No update available.

 

Update: 20 December 2023

DISC-3405 (formerly MWTX-003) was in-licensed from Mabwell Therapeutics. It received IND approval from the US FDA in November 2022 and was fast-tracked by the FDA for polycythemia vera in September 2023.

Preclinical studies of DISC-3405 have demonstrated an increase in hepcidin production and suppression of serum iron levels in animal models of beta-thalassemia and polycythemia vera.

A Phase 1 clinical study in healthy volunteers was initiated in October 2023.

DISC-3405 could potentially treat multiple iron overload disorders, such a polycythemia vera, beta thalassemia, and other indications. By inhibiting TMPRSS6, DISC-3405, an anti-TMPRSS6 antibody, is designed to increase the production of hepcidin to therapeutically reduce iron.

Sources: https://www.discmedicine.com/our-pipeline/mat-2-inhibitor/
https://ir.discmedicine.com/news-releases/news-release-details/disc-medicine-reports-third-quarter-2023-financial-results-and
https://ir.discmedicine.com/news-releases/news-release-details/disc-medicine-initiates-phase-1-study-disc-3405-anti-tmprss6-mab

 

Update: 30 September 2023

No update available.

 

Update: 30 June 2023

  • Phase 1 trial to begin in second half of 2023 with a focus on polycythemia vera to prove therapeutic hypothesis and assess safety. Subsequently, Phase 1b proof-of-concept studies can be undertaken in thalassaemia.

Source: https://ir.discmedicine.com/static-files/549caf12-e7be-45ff-8667-86908e4e6bdd

 

Update: 31 March 2023

  • Disc Medicine Inc and Mabwell Therapeutics have entered into an agreement to obtain an exclusive license to a portfolio of monoclonal antibodies targeting TMPRSS6 (Transmembrane Serine Protease 6, also known as Matriptase-2) including the phase 1-ready drug candidate MWTX-003.
  • Disc plans to initiate a phase 1 trial in healthy volunteers in the second half of 2023. MWTX-003 has the potential to address a wide range of hematologic disorders including polycythemia vera and beta-thalassemia by controlling iron homeostasis. Genetic studies show that TMPRSS6 affects red blood cell formation by controlling the level of iron that is available for erythropoiesis.
  • Clinical and non-clinical evidence has shown that increasing hepcidin and reducing iron levels by inhibiting TMPRSS6 has potential to treat hematologic disorders.
  • MWTX-003 is phase 1-ready and received acceptance of an Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) in November 2022.

Sources: https://ir.discmedicine.com/news-releases/news-release-details/disc-medicine-announces-exclusive-licensing-agreement-mabwell
https://ir.discmedicine.com/news-releases/news-release-details/disc-medicine-reports-first-quarter-2023-financial-results-and

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