RLYB-116 is under clinical development by Rallybio and currently in Phase I for Myasthenia Gravis. According to GlobalData, Phase I drugs for Myasthenia Gravis have a 95% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how RLYB-116’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.

RLYB-116 overview

RLYB-116 is under development for the treatment of paroxysmal nocturnal hemoglobinuria and myasthenia gravis. It is administered through subcutaneous route. RLYB-116 is a fusion protein which acts by targeting C5. The Affibody domain of RLYB-116 binds with high affinity to C5, thereby inhibiting terminal complement activation, while the Albumod technology albumin-binding domain (ABD) binds with high affinity to serum albumin, thereby extending the plasma half-life of the protein.

Rallybio overview

Rallybio is a biotechnology company. The company involves in the discovering, developing, manufacturing, and delivering therapies that improve the lives of patients suffering from severe and rare diseases. It also develop transformative medicines for the treatment of severe and rare disorders. Rallybio discovers and develops novel drug candidates including small molecules, engineered proteins, and antibodies. The company conducts pharmaceutical research and development to identify, evaluate and acquire small molecule and protein-based assets for drug development that transforms the lives of patients with devastating diseases. Rallybio is headquartered in Farmington, Connecticut, the US.

For a complete picture of RLYB-116’s drug-specific PTSR and LoA scores, buy the report here.


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 its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.