Lots of companies are developing treatments for migraine headaches. A cursory search on the ClinicalTrials.gov website comes up with 476 clinical trials in various stages of development. But when you look at how many companies are specifically targeting the molecule that triggers migraine headaches — calcitonin gene-related peptide — it is just a handful. Of those, Alder Biopharmaceuticals is one of a few in active clinical trials.
Alder, based in Washington state, is developing a monoclonal antibody to go after CGRP. It believes its drug could have a life-changing impact on the lives of chronic migraine sufferers.
In a phone interview with MedCity News, John Latham, a co-founder and chief scientific officer for Alder, said users would inject a dose of the antibodies through its ALD403 therapeutic on a monthly basis that could stay in the blood stream for longer than, say, a small molecule. “If we give our drug to patients we can mitigate the number of headaches they get per month.” The drug is in phase 1 development. Last year it conducted a successful trial to assess the drug’s safety. The next step will be to test it in patients with migraines in a Phase 2a placebo-controlled efficacy trial.
Latham said the company’s goal for the drug is to make it part of a monthly routine in which patients could use a a pen-like device and inject themselves on the upper thigh or abdomen.
About 14 million people are defined as chronic sufferers of migraines because they have them at least twice per month. The debilitating headaches can be accompanied by nausea, sensitivity to light and sound. People at the severe end of the spectrum may have six or more attacks per month. Migraines exact a big cost on the people who have them through their quality of life. It can make them miss work and affect their social life. And so many things can influence them from barometric pressure to red wine, chocolate and strong aged cheese.
The company avoids calling its antibody a cure, but believes it will improve patients’ lives. “In migraine headache management, you want to stop the headache from even developing,” said Latham. “You would like to be able to give a large dose of the drug to neutralize the initiating biology right from the get go.”
It could be a wonderdrug for the company, and is part of a pipeline that includes a Phase 2b rheumatoid arthritis treatment and therapeutic to fight various forms of cancer. It is getting good feedback from investors and raised $38 million in a Series D financing round last year. One challenge rests with its price. At an estimated $5,000 to $8,000 per year the price range rivals Botox injections.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
According to Chemical & Engineering News, only two other companies have CGRP therapeutics in development. Bristol-Myers Squibb and Arteaus Therapeutics, a Cambridge, Massachusetts firm that has licensed technology from Eli Lilly & Co, each has a drug in phase 2 development. Merck and Pfizer discontinued their CGRP therapeutics and although Boehringer-Ingelheim discontinued development of one therapeutic the status of a second is unknown.
