FDA Awards IC14 as Orphan Drug for MND

January 12, 2021
Posted in Company News
January 12, 2021 Implicit Bioscience

The FDA has designated Brisbane biotech Implicit Bioscience’s biologic IC14 an Orphan Drug for the treatment of motor neurone disease.

Orphan Drug status provides seven years of commercial exclusivity for drugs developed to treat rare disorders.

In 2017, Implicit Bioscience was awarded a $1m grant to commence development by FightMND and completed a study in acute dosing of 10 patients at Royal Brisbane & Women’s Hospital with Professors Rob Henderson and Pam McCombe.

This was followed by an Expanded Access Protocol in the largest clinical research centre working in this disease – the Healey Center for ALS at Massachusetts General Hospital.

Professor Merit Cudkowicz has treated nine patients with several now dosed out beyond 12 months.

Implicit is also collaborating with Professor Stanley Appel at the Houston Methodist Neurological Institute and expects to shortly start enrolling patients there, ahead of a large phase 2b study across the US on the Healey Center clinical platform scheduled to begin in August.