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Find Musculoskeletal Drugs in Phase II Clinical Development in UNITED STATES

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            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 May 21, 2020

            Details:

            Fulcrum Therapeutics have identified a set of stable DUX4-regulated gene transcripts that provide a pharmacodynamic biomarker endpoint to measure the treatment effect of losmapimod in FSHD.

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            Lead Product(s): Dexamethasone Sodium Phosphate

            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 May 18, 2020

            Details:

            Subgroup analyses of Phase II data confirm robustness of TLC599’s efficacy response of greater pain reductions than placebo through 24 weeks.

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            Lead Product(s): TPX-100

            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 May 12, 2020

            Details:

            TPX-100-treated knees demonstrated clinically meaningful and statistically significant improvement in critical knee functions as compared to placebo-treated knees.

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            Lead Product(s): UBX0101

            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 March 31, 2020

            Details:

            UNITY has completed its Phase 1b study to explore the safety, tolerability and initial efficacy of a single 8.0 mg dose or multiple doses of UBX0101.

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            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 March 24, 2020

            Details:

            Phase 1 trial data support the use of the 15 mg losmapimod dose taken orally twice daily in the Company's current phase 2b clinical trial, ReDUX4, as well as its open label Phase 2 analysis.

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            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 February 26, 2020

            Details:

            An open label extension for participants in ReDUX4 who have completed 24 weeks of dosing has also initiated, providing the opportunity for patients randomized to losmapimod to continue treatment.

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            Lead Product(s): DYV-700

            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 February 20, 2020

            Details:

            Dyve’s Phase 2 trial is designed to enroll 300 subjects across 20 trial centers in the U.S.

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            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.

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            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.

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            Lead Product(s): Edasalonexent

            Therapeutic Area: Musculoskeletal

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Duchenne UK

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Partnership January 08, 2020

            Details:

            The partnership is to evaluate Edasalonexent a novel NF-kB inhibitor, in a Phase 2 Non-Ambulatory Duchenne Muscular Dystrophy Trial.