Musculoskeletal | Phase II Developments | UNITED STATES

Selecta Biosciences

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Chinaplas 2020

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Sobi and Selecta Announce Strategic Licensing Agreement for SEL-212, a Phase 3-ready Novel Treatment for Chronic Refractory Gout

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.

Neurana Pharmaceuticals

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Chinaplas 2020

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Neurana Pharmaceuticals Announces First Patient Enrolled in CNS Effects Clinical Study

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.

Longeveron LLC

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Longeveron Announces Japanese Approval of Clinical Trial for Treatment of Aging Frailty With Longeveron's Stem Cells

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.

Fulcrum Therapeutics

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Chinaplas 2020

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Fulcrum Therapeutics Announces Multiple Presentations at the 2020 American Academy of Neurology (AAN) Science Highlights Virtual Platform

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.

Tlc Therapeutics

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Chinaplas 2020

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TLC Highlights Findings in Abstract Accepted at OARSI 2020 and Published in Osteoarthritis and Cartilage

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.

OrthoTrophix

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Chinaplas 2020

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OrthoTrophix Presents More Evidence on TPX-100 for Disease Modification in Knee Osteoarthritis in a New Abstract Published in a Journal

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.

Unity Biotechnology

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Chinaplas 2020

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UNITY Biotechnology Completes Enrollment in Phase 1b Study of UBX0101

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.

Fulcrum Therapeutics

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Fulcrum Therapeutics Announces Complete Data from Phase 1 Trial with Losmapimod in Facioscapulohumeral Muscular Dystrophy (FSHD)

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.

Fulcrum Therapeutics

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Fulcrum Therapeutics Announces Completion of Enrollment in Phase 2b Trial of Losmapimod in FSHD

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.

Dyve Biosciences

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Dyve Biosciences Announces First Patient Enrolled in TARGETS Study for Treatment of Acute Gout

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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Find Musculoskeletal Drugs in Phase II Clinical Development in UNITED STATES

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Companies

Selecta Biosciences

Sobi and Selecta Announce Strategic Licensing Agreement for SEL-212, a Phase 3-ready Novel Treatment for Chronic Refractory Gout

Neurana Pharmaceuticals

Neurana Pharmaceuticals Announces First Patient Enrolled in CNS Effects Clinical Study

Longeveron LLC

Longeveron Announces Japanese Approval of Clinical Trial for Treatment of Aging Frailty With Longeveron's Stem Cells

Fulcrum Therapeutics

Fulcrum Therapeutics Announces Multiple Presentations at the 2020 American Academy of Neurology (AAN) Science Highlights Virtual Platform

Tlc Therapeutics

TLC Highlights Findings in Abstract Accepted at OARSI 2020 and Published in Osteoarthritis and Cartilage

OrthoTrophix

OrthoTrophix Presents More Evidence on TPX-100 for Disease Modification in Knee Osteoarthritis in a New Abstract Published in a Journal

Unity Biotechnology

UNITY Biotechnology Completes Enrollment in Phase 1b Study of UBX0101

Fulcrum Therapeutics

Fulcrum Therapeutics Announces Complete Data from Phase 1 Trial with Losmapimod in Facioscapulohumeral Muscular Dystrophy (FSHD)

Fulcrum Therapeutics

Fulcrum Therapeutics Announces Completion of Enrollment in Phase 2b Trial of Losmapimod in FSHD

Dyve Biosciences

Dyve Biosciences Announces First Patient Enrolled in TARGETS Study for Treatment of Acute Gout