Alder BioPharmaceuticals has dosed the first participant in a Phase I clinical trial being conducted to assess its investigational monoclonal antibody (mAb) ALD1910 for the prevention of migraine.
ALD1910 inhibits pituitary adenylate cyclase-activating polypeptide (PACAP), which is a key signalling molecule in the pathophysiology of migraine.
PACAP and its receptors are known to be located across the pain-processing pathway. Elevated PACAP levels are also said to be present in blood samples of patients having a migraine attack.
Preclinical studies found that ALD1910 possesses selectivity and high-affinity for in vivo engagement of PACAP.
Alder BioPharmaceuticals chief medical officer Paul Streck said: “PACAP is an attractive pathway in addressing migraine and the preclinical work has been very encouraging as it demonstrated ALD1910 prevents the signalling of PACAP with all three known receptors.”
During the double-blind, placebo-controlled Phase I trial, ALD1910’s safety, tolerability and pharmacokinetic profile will be investigated in 100 healthy volunteers aged 18-55.
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Alder expects to report initial data from the trial in the second half of next year.
The drug candidate is expected to help prevent migraine in individuals who do not experience an adequate response to other therapies, offering a mechanism-specific therapy.
Alder BioPharmaceuticals president and CEO Bob Azelby said: “More than 70% of the 14 million people with migraine who experience more than four headache days per month are not being treated with preventive therapies.
“We believe that no single treatment mechanism is going to benefit every person living with this disease. ALD1910 has the potential to provide a new mechanism-specific therapeutic approach for people with migraine and their physicians.”
Migraine is a neurological disease that causes recurrent, moderate to severe headache episodes. It is estimated to affect more than 134 million people per year.
The condition is also characterised by nausea, vomiting, and sensitivities to light and sound.