Musculoskeletal | Phase II Developments

Virios Therapeutic

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Fibromyalgia biotech Virios Therapeutics files for a $35 million IPO

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.

Unity Biotechnology

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Unity Biotechnology Announces 12-Week Data From Ubx0101 Phase 2 Clinical Study In Patients With Painful Osteoarthritis Of The Knee

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.

Fulcrum Therapeutics

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Fulcrum’s losmapimod Fails Interim Analysis in Muscle Wasting Trial

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.

EnteraBio Ltd

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Entera Bio Announces Management Changes

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.

Selecta Biosciences

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Sobi And Selecta Announce Closing of Previously Announced Strategic Licensing Agreement For Sel-212

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.

EnteraBio Ltd

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Entera Bio Ltd Provides Update on Phase 2 Clinical Trial of EB613 in Postmenopausal Women With Osteoporosis

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.

Selecta Biosciences

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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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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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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.

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Find Musculoskeletal Drugs in Phase II Clinical Development

Phase II

Product Type

Companies

Virios Therapeutic

Fibromyalgia biotech Virios Therapeutics files for a $35 million IPO

Unity Biotechnology

Unity Biotechnology Announces 12-Week Data From Ubx0101 Phase 2 Clinical Study In Patients With Painful Osteoarthritis Of The Knee

Fulcrum Therapeutics

Fulcrum’s losmapimod Fails Interim Analysis in Muscle Wasting Trial

EnteraBio Ltd

Entera Bio Announces Management Changes

Selecta Biosciences

Sobi And Selecta Announce Closing of Previously Announced Strategic Licensing Agreement For Sel-212

EnteraBio Ltd

Entera Bio Ltd Provides Update on Phase 2 Clinical Trial of EB613 in Postmenopausal Women With Osteoporosis

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