Product Description
Dynacure is developing DYN101, an investigational antisense product candidate designed to reduce the expression of dynamin 2 protein for the treatment of Myotubular and Centronuclear Myopathies, in strategic collaboration with Ionis Pharmaceuticals.
Mechanisms of Action: DNM2 Inhibitor
Novel Mechanism: Yes
Modality: Nucleic Acid
Route of Administration: N/A
FDA Designation: Fast Track - X-linked myotubular myopathy *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: Dynacure
Company Location:
Company CEO:
Additional Commercial Interests: None
Clinical Description
Countries in Clinic:
Active Clinical Trial Count:
Recent & Upcoming Milestones
Highest Development Phases
Phase 2: Myopathies, Structural, Congenital
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT04743557 |
DyNaMic | P2 |
Withdrawn |
Myopathies, Structural, Congenital |
2025-09-01 |
33% |
2022-07-13 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments|Trial Status |
NCT04033159 |
Unite-CNM | P2 |
Terminated |
Myopathies, Structural, Congenital |
2022-06-22 |
17% |
2023-06-28 |
Patient Enrollment|Primary Endpoints|Treatments |
2018-004089-33 |
Research Using an Investigational Treatment for CNM (Unite-CNM) | P2 |
Completed |
Unknown |
2021-10-27 |
2025-05-06 |
Treatments|Trial Status |
|
2020-004608-32 |
Research Using an Investigational Treatment for CNM (DyNaMic) | P2 |
Unknown status |
Unknown |
None |
33% |
2022-03-13 |
Treatments |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
01/06/2022 |
News Article |
Dynacure Receives Fast Track Designation for DYN101, an Investigational Antisense Oligonucleotide for the Treatment of Myotubular and Centronuclear Myopathies |
|
01/03/2022 |
News Article |
Dynacure to Present at 40th Annual J.P. Morgan Healthcare Conference |
|
11/10/2021 |
News Article |
Dynacure Announces Strategic Collaboration and Option Agreement with Nippon Shinyaku |
|
09/16/2021 |
News Article |
Dynacure to Present Preclinical Data on Disease Progression Modelling and ASO-Mediated Dynamin 2 Knockdown at World Muscle Society (WMS) Meeting |