Polyneuron has been granted the orphan drug designation by the US FDA to PN-1007 in the treatment of anti-MAG neuropathy, a disabling chronic disorder of the peripheral nervous system. This announcement follows the same designation from the European Medicines Agency in July 2017.
The orphan drug designation can only be granted for treatments on rare diseases to advance the developments of safe and effective therapies and the FDA may provide grant funding and other benefits to support Polyneuron’s efforts.
The team moves one step closer to the clinics as the phase I/II study in anti MAG neuropathy will start in patients later in 2020, following successful in vivo efficacy and safety studies in mice.
For more details, you can have access to the press release here.