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Find Musculoskeletal Drugs in Phase II Clinical Development

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            Lead Product(s): Pegadricase

            Therapeutic Area: Musculoskeletal Product Name: Undisclosed

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Swedish Orphan Biovitrum AB

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Licensing Agreement June 11, 2020

            Details:

            This strategic licensing agreement is for SEL-212, a combination of Selecta's tolerogenic ImmTOR immune tolerance platform and a therapeutic uricase enzyme (pegadricase) for the treatment of chronic refractory gout.

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            Lead Product(s): Tolperisone

            Therapeutic Area: Musculoskeletal Product Name: Undisclosed

            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 June 08, 2020

            Details:

            The study is a randomized, 4-period, crossover study designed to investigate the effects of tolperisone on measures of drowsiness and cognitive function compared to cyclobenzaprine and placebo.

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            Lead Product(s): Longeveron Mesenchymal Stem Cells

            Therapeutic Area: Musculoskeletal Product Name: Undisclosed

            Highest Development Status: Phase II Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 01, 2020

            Details:

            The Phase 2 study will assess the safety and efficacy of Longeveron's stem cell treatment under Japan's accelerated regulatory pathway for regenerative medicine.

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            Lead Product(s): Losmapimod

            Therapeutic Area: Musculoskeletal Product Name: Undisclosed

            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 Product Name: Undisclosed

            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 Product Name: Undisclosed

            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 Product Name: Undisclosed

            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 Product Name: Undisclosed

            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 Product Name: Undisclosed

            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 Product Name: Undisclosed

            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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