Find Musculoskeletal Drugs in Phase II Clinical Development

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            Lead Product(s): IMC-1

            Therapeutic Area: Musculoskeletal Product Name: IMC-1

            Highest Development Status: Phase II Product Type: Undisclosed

            Partner/Sponsor/Collaborator: Undisclosed

            Deal Size: $35.0 million Upfront Cash: Undisclosed

            Deal Type: Public Offering August 28, 2020

            Details:

            The company's lead candidate, IMC-1, is a novel combination antiviral therapy designed to synergistically suppress Herpes Simplex Virus-1activation and replication, with the end goal of reducing viral mediated disease burden.

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            Lead Product(s): UBX0101

            Therapeutic Area: Musculoskeletal Product Name: UBX0101

            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 August 17, 2020

            Details:

            There was no statistically significant difference between any arm of UBX0101 and placebo at the 12-week endpoint for change from baseline in WOMAC-A, an established measurement of pain in OA.

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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 August 11, 2020

            Details:

            Results from the interim analysis in the first 29 randomized subjects indicate that DUX4-driven gene expression did not show a separation from placebo at 16 weeks.

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            Lead Product(s): Teriparatide

            Therapeutic Area: Musculoskeletal Product Name: EB613

            Highest Development Status: Phase II Product Type: Peptide

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 10, 2020

            Details:

            Entera's intend to move EB613 development program into a Phase 2b or Phase 3 pivotal clinical trial.

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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: $100.0 million Upfront Cash: $100.0 million

            Deal Type: Licensing Agreement July 28, 2020

            Details:

            The licensing agreement includes the global rights, excluding China, for the product SEL-212. SEL-212 is a combination of Selecta's tolerogenic ImmTOR immune tolerance platform and a therapeutic uricase enzyme that is designed for the treatment of chronic refractory gout.

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            Lead Product(s): Teriparatide

            Therapeutic Area: Musculoskeletal Product Name: EB613

            Highest Development Status: Phase II Product Type: Peptide

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 07, 2020

            Details:

            Entera Bio received an approval from the IRBs at the clinical sites for the amendment to its Phase 2 protocol to include the testing of higher doses of EB613.

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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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