Musculoskeletal | Phase II Developments | UNITED STATES

Fulcrum Therapeutics

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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

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

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.

OrthoTrophix

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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

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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UNITY Biotechnology Completes Enrollment in Phase 1b Study of UBX0101

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.

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

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

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

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.

Fulcrum Therapeutics

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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.

Ultragenyx Pharmaceutical

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

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.

Catabasis Pharmaceuticals

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Catabasis Pharmaceuticals and Duchenne UK Announce Partnership to Evaluate Edasalonexent in a Phase 2 Non-Ambulatory Duchenne Muscular Dystr...

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.

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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

Fulcrum Therapeutics

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

Ultragenyx Pharmaceutical

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

Catabasis Pharmaceuticals

Catabasis Pharmaceuticals and Duchenne UK Announce Partnership to Evaluate Edasalonexent in a Phase 2 Non-Ambulatory Duchenne Muscular Dystr...