Musculoskeletal | Phase III Developments

Pfizer Inc

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Pfizer’s New Phase 1b Results of Gene Therapy in Ambulatory Boys with DMD Support Advancement into Pivotal Phase 3 Study

Lead Product(s): PF-06939926

Therapeutic Area: Musculoskeletal Product Name: Undisclosed

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

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 15, 2020

Details:

The preliminary data from 9 ambulatory boys with DMD, aged 6 to 12 indicate that the intravenous administration of PF-06939926 was well-tolerated during the infusion period, with encouraging efficacy and manageable safety events.

Pfizer Inc

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Pfizer to Host Free Webinar on Pfizer’s Advancement to Phase III Gene Therapy Clinical Trial

Lead Product(s): PF-06939926

Therapeutic Area: Musculoskeletal Product Name: Undisclosed

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

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 10, 2020

Details:

First ever Phase III gene therapy clinical trial for Duchenne muscular dystrophy.

Samumed

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Samumed Announces Publication of Phase 2 Data on Lorecivivint, Now in Pivotal Trials for Knee Osteoarthritis

Lead Product(s): Lorecivivint

Therapeutic Area: Musculoskeletal Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 22, 2020

Details:

Phase 2a data highlight the disease modifying promise of lorecivivint based on its ability to slow joint space narrowing, while durably improving pain and function over one year.

Tonix Pharmaceuticals Holding Corp

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Tonix Pharmaceuticals Posted Results from Pharmacokinetic Analyses of TNX-102 SL and TNX-601 CR at ASCP 2020 Meeting

Lead Product(s): Cyclobenzaprine Hydrochloride

Therapeutic Area: Musculoskeletal Product Name: Undisclosed

Highest Development Status: Phase III 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:

A poster to be presented includes pharmacokinetic (PK) analyses of TNX-102 SL that is being developed as a bedtime treatment for fibromyalgia, posttraumatic stress disorder (PTSD), agitation in Alzheimer’s disease (ADD) and alcohol use disorder (AUD).

Bone Therapeutics

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BELGIUM Belgium

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Bone Therapeutics Treats First Patients in Pivotal JTA-004 Phase III Knee Osteoarthritis Study

Lead Product(s): Hyaluronic Acid,Plasma proteins,Fast-acting analgesic

Therapeutic Area: Musculoskeletal Product Name: Undisclosed

Highest Development Status: Phase III 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:

The JTA-004 phase III study is a controlled, randomized, double-blind trial that will evaluate the potential of a single, intra-articular injection of JTA-004 to reduce osteoarthritic pain in the knee compared to placebo or Hylan G-F 20.

Tonix Pharmaceuticals Holding Corp

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Tonix Pharmaceuticals Achieves 50 Percent Enrollment in Phase 3 RELIEF Study of TNX-102 SL for Management of Fibromyalgia

Lead Product(s): Cyclobenzaprine Hydrochloride

Therapeutic Area: Musculoskeletal Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 24, 2020

Details:

50 percent of the planned total number of participants have been randomized in the Phase 3 RELIEF trial evaluating TNX-102 SL for the management of fibromyalgia.

Paradigm Biopharmaceuticals

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Australia

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Paradigm Biopharmaceuticals has Significant Clarity on Development Pathway for Zilusol

Lead Product(s): Pentosan Polysulfate Sodium

Therapeutic Area: Musculoskeletal Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Bell Potter Securities

Deal Size: $35.0 million Upfront Cash: Undisclosed

Deal Type: Financing April 20, 2020

Details:

Proceeds will be applied to costs of the second phase 3 osteoarthritis (OA) clinical trial and leaves Paradigm fully-funded through to completion of this trial.

Kolon TissueGene

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United States

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Kolon Tissuegene Announces Plans To Resume US Phase III Clinical Trial For TG-C

Lead Product(s): TissueGene-C

Therapeutic Area: Musculoskeletal Product Name: Undisclosed

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

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 13, 2020

Details:

The trial had been suspended due to product identity concerns. Kolon TissueGene has begun activities to resume the phase III trial and reinitiate enrollment later this year.

Ra Pharmaceuticals

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United States

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UCB Completes the Acquisition of Ra Pharmaceuticals - to Deliver Differentiated Therapies to Patients

Lead Product(s): Zilucoplan

Therapeutic Area: Musculoskeletal Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: UCB Pharma S.A.

Deal Size: $ 2,300.0 million Upfront Cash: Undisclosed

Deal Type: Acquisition April 02, 2020

Details:

The transaction will enhance UCB’s potential to be a leader in myasthenia gravis by adding zilucoplan, currently in phase 3, to the UCB pipeline alongside rozanolixizumab.

Seikagaku

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JAPAN Japan

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Eisai and Seikagaku Enter into Agreement for the Co-development and Marketing Alliance of SI-613

Lead Product(s): Diclofenac conjugated sodium hyaluronate

Therapeutic Area: Musculoskeletal Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Eisai

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement April 01, 2020

Details:

The companies will jointly develop SI-613 in China for knee osteoarthritis. After obtaining approval, Seikagaku will supply products to Eisai, and Eisai will be responsible for distribution.

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Find Musculoskeletal Drugs in Phase III Clinical Development

Phase III

Product Type

Companies

Pfizer Inc

Pfizer’s New Phase 1b Results of Gene Therapy in Ambulatory Boys with DMD Support Advancement into Pivotal Phase 3 Study

Pfizer Inc

Pfizer to Host Free Webinar on Pfizer’s Advancement to Phase III Gene Therapy Clinical Trial

Samumed

Samumed Announces Publication of Phase 2 Data on Lorecivivint, Now in Pivotal Trials for Knee Osteoarthritis

Tonix Pharmaceuticals Holding Corp

Tonix Pharmaceuticals Posted Results from Pharmacokinetic Analyses of TNX-102 SL and TNX-601 CR at ASCP 2020 Meeting

Bone Therapeutics

Bone Therapeutics Treats First Patients in Pivotal JTA-004 Phase III Knee Osteoarthritis Study

Tonix Pharmaceuticals Holding Corp

Tonix Pharmaceuticals Achieves 50 Percent Enrollment in Phase 3 RELIEF Study of TNX-102 SL for Management of Fibromyalgia

Paradigm Biopharmaceuticals

Paradigm Biopharmaceuticals has Significant Clarity on Development Pathway for Zilusol

Kolon TissueGene

Kolon Tissuegene Announces Plans To Resume US Phase III Clinical Trial For TG-C

Ra Pharmaceuticals

UCB Completes the Acquisition of Ra Pharmaceuticals - to Deliver Differentiated Therapies to Patients

Seikagaku

Eisai and Seikagaku Enter into Agreement for the Co-development and Marketing Alliance of SI-613