BRTX-100 is under clinical development by BioRestorative Therapies and currently in Phase II for Chronic Low Back Pain (CLBP). According to GlobalData, Phase II drugs for Chronic Low Back Pain (CLBP) have a 57% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how BRTX-100’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

BRTX-100 overview

BRTX-100 is under development for the treatment of chronic low back pain caused due to degenerative disc disease related to protruding/bulging discs, pain related to cervical, thoracic, musculoskeletal pain related to hip/knees, extremities, avascular zones. The therapeutic candidate consists of autologous, hypoxic cultured mesenchymal stem cells. The drug candidate uses a needle/catheter stem cell delivery device for the precise delivery of stem cells in the disc region that is damaged. The brtxDISC implantation device uses an internal nitinol catheter and an external nitinol guide cannula. It is administered as an intradiscal injection.

BioRestorative Therapies overview

BioRestorative Therapies (BRT) is a developer of therapeutic products and medical therapies. The company performs stem cell programs which include BRTX-100 and ThermoStem. BRTX-100, a lead therapeutic product, is designed to offer a non-surgical treatment for chronic lumbar disc diseases such as bulging and herniated discs. Its ThermoStem program develops brown fat stem cell-based therapy which is used for the treatment of type 2 diabetes, obesity, and other metabolic disorders. BRT provides identification and treatment of the first stem cell population isolated from a particular brown fat depot in humans. BRT is headquartered in Melville, New York, the US.

For a complete picture of BRTX-100’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 10 June 2024

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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.