For more than 40 years, John Latham, a veteran researcher, scientist, and biotechnology industry professional, watched his wife, Nanette, suffer the effects of migraine.
The disease, which impacts nearly 40 million people in the United States, is known for its throbbing, pounding pain — sometimes described as an icepick being pushed through one’s forehead or eyeball — and carries ancillary effects, such as anxiety, cognitive issues, depression, fatigue, insomnia, irritability, and nausea.
As a whole, few things disrupt one’s home and work life quite like migraine. Just ask Latham, who first witnessed Nanette suffer the effects while the pair were college students in the 1980s.
“I never understood why she missed classes at least a day a week,” he recalled. “And it got progressively worse from there.”
In 2004, Latham set out to find a medical solution to migraine pain. Along with Randy Schatzman, Dr. Jeffrey Smith, and Mark Litton, Latham co-founded Alder BioPharmaceuticals with that goal in mind. Eight years later, the company started clinical trials of its flagship medicine — ALD403, also known as Eptinezumab — an investigational monoclonal antibody that targets Calcitonin Gene-Related Peptide (CGRP), a small protein that acts as a neurotransmitter, and also triggers the pain and inflammation associated with most migraine episodes.
In simpler terms, during periods of migraine, CGRP is released into the bloodstream, eventually engaging with CGRP receptors and resulting in a cascade of pain. Eptinezumab, a sort of anti-ballistic missile, captures and encapsulates CGRP before it has an opportunity to engage the receptors.
According to information and study results provided by Alder BioPharmaceuticals, two clinical trials involving nearly 2,100 patients who suffer chronic and episodic migraine evaluated Eptinezumab’s safety and efficacy in blocking CGRP.
For study participants who experienced 16 migraines per month, approximately 60 percent reported fewer than eight migraines per month, approximately one-third reported fewer than four per month, and approximately 15 percent of patients did not experience migraine for one month over a three-month period.
“We are really proud of the fact that we saw a really good depth of response in the percentage of patients that were seeing significant reduction,” explained Bob Azelby, CEO of Alder BioPharmaceuticals, a publicly traded company headquartered in Bothell. “It’s game-changing for those patients in terms of reductions in migraine.”
This spring, the Federal Drug Administration (FDA) began its review of the Biologics License Application for Eptinezumab, the final leg of a journey toward FDA approval and the commercial availability of Eptinezumab.
Alder BioPharmaceuticals is not without competitors. The FDA has approved three other anti-CGRP medicines to prevent migraine. Amgen offers Aimovig. Lilly offers Emgality. Teva offers Ajovy. All three drugs involve pre-filled syringes, pens, or auto-injectors, which are prescribed by a doctor and filled at pharmacies.
But Azelby — who started his career as a pharmaceutical representative at Glaxo in the early 1990s, spent 15 years as an executive at Amgen, then another two and a half years as an executive at Juno Therapeutics before he was hired in June 2018 to be CEO of Alder BioPharmaceuticals — believes Eptinezumab has advantages.
If approved by the FDA, patients treated with Eptinezumab would visit a neurologist once every 12 weeks for a 30-minute IV infusion of the medicine, and experience results within 24 hours. Once that 30-minute visit ends, the patient would have 100 percent of the medicine available to block CGRP, according to Azelby.
“That’s the differentiation or the unique characteristics of Eptinezumab — the fact that you are getting really good depth of response, and you can get it starting within 24 hours,” Azelby said.
Azelby is optimistic about the FDA’s decision regarding Eptinezumab, which is expected to be made in early 2020.
Alder BioPharmaceuticals started this year with approximately 200 employees. In anticipation of the FDA’s decision, the company is building a sales force of 75 to 100 people to meet with doctors and clinicians who treat migraine patients, educating them on Eptinezumab’s clinical profile, safety, and efficacy.
“We are really confident that you don’t have to be big to be effective,” Azelby noted. “There’s going to be a nice set of patients that Eptinezumab is going to benefit.”
Until then, Azelby said he is focused on Alder BioPharmaceuticals achieving three key goals in the near future. The first two are to receive FDA approval and to build a well-trained and dedicated sales force.
The third goal, however, speaks directly to co-founder Latham’s original vision for migraine treatment.
“Doctors are accessing Eptinezumab and giving it to their patients, and it’s having a really positive impact on patients,” Azelby said. “That would be a huge win.”