AbbVie gets orphan drug and fast track status for elezanumab

AbbVie has received orphan drug and fast track designations from the US Food and Drug Administration (FDA) for elezanumab (ABT-555) to treat spinal cord injury (SCI).

Elezanumab is a monoclonal antibody of the human immunoglobulin (Ig) G1 isotype, which attaches to repulsive guidance molecule A (RGMa).

RGMa inhibits axonal outgrowth and is significant in hindering neuronal regeneration and functional recovery after damage to the central nervous system (CNS).

The FDA offers orphan drug designation to a therapeutic meant for the treatment, diagnosis or prevention of a rare disease or condition.

Meanwhile, fast track designation expedites the review of drugs for serious disorders or conditions with an unmet medical need.

AbbVie Neuroscience Development vice-president Michael Gold said: “The FDA’s orphan drug and fast track designation for spinal cord injury patients signals an important step forward in AbbVie’s ongoing commitment to investigating innovative scientific approaches with the hope of bringing new treatment options to patients.”

Studies of elezanumab to treat spinal cord injuries, as well as multiple sclerosis and acute ischemic stroke, are under progress. The drug candidate is undergoing a Phase II clinical trial for SCI.

The randomised, double-blind, placebo-controlled Phase II trial analyses the safety and efficacy of elezanumab in acute traumatic cervical SCI. Its primary outcome is the upper extremity motor score (UEMS) at week 52.

Patients will receive intravenous doses of elezanumab or placebo within 24 hours of injury, given a dose every four weeks until week 48 thereafter.

AbbVie partnered with Shirley Ryan AbilityLab and MC10 on an ongoing pilot study of 20 SCI patients. This study, scheduled for completion in around two months, will help inform the Phase II trial.

Earlier this month, AbbVie signed a deal with I-Mab to develop and commercialise lemzoparlimab, an immuno-oncology therapy.