DB-001 is under clinical development by Direct Biologics and currently in Phase II for Crohn’s Disease (Regional Enteritis). According to GlobalData, Phase II drugs for Crohn’s Disease (Regional Enteritis) have a 48% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how DB-001’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.

DB-001 overview

DB-001 is under development for the treatment of moderate-to-severe acute respiratory distress syndrome (ARDS), post-acute sequelae of covid 2019 (PASC or long covid), refractory crohn disease, refractory ulcerative colitis, chronic degenerated facet low back pain and abdominal solid organ transplant rejection. It is administered by intravenous route. The drug candidate comprises of exosomes isolated from human bone marrow mesenchymal stem (MSCs). It is being developed based on EV platform technology.

It was also under development for the treatment of coronavirus disease 2019.

Direct Biologics overview

Direct Biologics manufactures medical equipments. It provides regenerative biologic products for replacing human cells, tissues, organs to restore normal function. This company is headquartered in Austin, Texas, the US.

For a complete picture of DB-001’s drug-specific PTSR and LoA scores, buy the report here.

Data Insights


The gold standard of business intelligence.

Blending expert knowledge with cutting-edge technology, GlobalData’s unrivalled proprietary data will enable you to decode what’s happening in your market. You can make better informed decisions and gain a future-proof advantage over your competitors.


GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

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.