Clinical trial updates
MWTX-003
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Product Information
Scientific name: MWTX-003
Brand name: Ν/Α
RESPONSIBLE: Disc Medicine Inc and Mabwell Therapeutics -
Clinical Trial/Study Information
Last update: 22/6/2023
Trial Name: N/A
Code: NCT06050915 [To be initiated in October 2023]
Phase: 1 (Proof-of Mechanism)
Eligible patient diagnosis: Healthy Volunteers
No. of Patients enrolled: N/A
Study Sites: N/A Sites per countryAnticipated 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
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: 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.
