Daval receives approval for Phase IIB trial of Aimspro

This double-blind placebo-controlled crossover study will seek to detect a beneficial effect on bladder function in patients with secondary progressive multiple sclerosis, following open-label observations over several years in a number of informed consent ‘compassionate basis’ patients.

Aimspro has an ‘export only’ listing on the Australian Registry of Therapeutic Goods and a TGA orphan status designation for the treatment of Krabbe’s disease. An IND application is being lodged for a further MS trial in the US.

Aimspro is a frozen medication, given as a 1ml sub-cutaneous injection every four days. It is believed to have a pronounced and sustained anti-inflammatory action with an associated, novel effect of lowering sodium channel-triggering voltages in nerve fibres.

MHRA applications for two further clinical trials are to be lodged within the next three months.