Musculoskeletal | Phase II Developments

Fulcrum Therapeutics, Inc

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United States

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Fulcrum Therapeutics Receives Orphan Drug Designation for Losmapimod in Facioscapulohumeral Muscular Dystrophy (FSHD) and Announces Expanded...

Lead Product(s): Losmapimod

Therapeutic Area: Musculoskeletal

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 29, 2020

Details:

The Phase 1 clinical trial of losmapimod in patients with FSHD, indicated that losmapimod was generally well tolerated and achieved dose-dependent concentrations in plasma and muscle.

Medivir AB

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SWEDEN Sweden

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Medivir's Phase II Study of MIV-711 in Patients With Osteoarthritis Published in Annals of Internal Medicine

Lead Product(s): MIV-711

Therapeutic Area: Musculoskeletal

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 20, 2020

Details:

The study demonstrated significant effect on changes in bone and cartilage degradation after six months of treatment with MIV-711.

Ultragenyx Pharmaceutical

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United States

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Ultragenyx and Kyowa Kirin Announce Submission of Supplemental Biologics License Application to U.S. FDA for CrysvitaÂ® (burosumab) for Tu...

Lead Product(s): Burosumab

Therapeutic Area: Musculoskeletal

Highest Development Status: Phase II Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 14, 2020

Details:

The sBLA package includes data from two single-arm Phase 2 studies including 14 adult patients conducted by Ultragenyx in the U.S. and 13 adult patients conducted by Kyowa Kirin in Japan.