Shooting for IPO glory, Alder cites trial success with migraine drug

A few weeks after Seattle-based Alder Biopharmaceuticals spelled out plans to raise $115 million in an IPO designed to propel them into the ranks of a fully diversified biotech company, the biotech has released some key data points from its proof-of-concept study on its experimental migraine therapy.

ALD403 met the primary endpoint on reducing the number of days a patient is afflicted with migraines compared with the placebo arm, says Alder. On any given month the drug eliminated all migraines for anywhere from 27% to 41% of all the patients in the drug arm. About one in 8 patients had no migraines over a period of three months after a single injection. And there was no difference in the safety profile when compared with a placebo.

Researchers for Alder will now detail the results of the 163-patient PoC study at a meeting of the American Academy of Neurology on May 2 in Philadelphia.

The study marks another key step forward for Alder, which is setting up a Phase IIb dose-ranging trial of the migraine drug in the second half of this year. Success there would put the biotech on the threshold of a pivotal Phase III trial, which is intended to provide the company with a product it can launch in 2016 with its own sales force.

And there's more to this company than a migraine drug.

Alder's S-1, filed in March, states that the biotech has grabbed $103.5 million in its deal with Bristol-Myers ($BMY), which is planning to wrap a Phase IIb study of its anti-IL-6 drug clazakizumab in rheumatoid arthritis patients in the second half of this year. If it is successful, a late-stage study aimed at putting the company on track to a new first-line anti-inflammatory could start in 2015, which would be worth a $40 million milestone. A total of $746 million in biobucks remains to be earned. Bristol-Myers and Alder outlined positive Phase IIb data for the drug in the fall of 2013.

"The results of this study represent an important milestone for the development of new treatments for patients disabled by migraine," noted Peter J. Goadsby, director of the NIHR-Wellcome Trust Clinical Research Facility, King's College London. "I am delighted that AAN selected this study evaluating ALD403 for the prevention of frequent episodic migraine as one of the emerging science abstracts for the conference this year."

- here's the release