Mr. King: Alexza Pharmaceuticals was founded in 2000 by world-renowned biotechnology and drug delivery serial entrepreneur, Dr. Alejandro Zaffaroni. And he brought together two important concepts to the founding of the company — one was the treatment of acute and intermittent medical conditions. Dr. Zaffaroni thought this was an area of medicine that had been mostly overlooked in drug development. And secondly, the concept of what we essentially now call Staccato® aerosol technology, which is using energy — in our case, heat — to create very pure aerosols for administration of drugs into the lungs. And it was those two concepts that provided the initial foundation for the company. In the nine years since the company was founded, we’ve moved the technology concept forward to an operational device. We actually have two different Staccato platforms, a single-dose and a multiple-dose device. Since 2004 we’ve filed six INDs on five different drug compounds, completed 22 clinical trials and dosed more than 2,600 subjects. Our lead product candidate is on track for our first NDA submission early next year. And so the company has evolved very quickly into a company developing new medicines for the treatment of acute and intermittent conditions, with a current focus in the CNS area. That focus is on drugs where you desire a rapid speed of onset combined with a patient’s ease of use, both enabled by our Staccato technology.
TWST: Please comment on your lead candidate as well as the other candidates in your clinical and pre-clinical pipeline.
Mr. King: Our lead compound is called AZ-004. AZ-004 is a condensation aerosol version of loxapine, which is a drug that was initially approved in the United States for general use in psychiatry in the mid-1970s. Our scientists felt that loxapine might be an ideal drug to be administered with our technology to develop a product specifically designed to rapidly treat agitation in patients with schizophrenia or bipolar disorder. The unmet medical need in treating agitation is the gap between the ideal treatment, as outlined in the consensus treatment guidelines, and the currently available products. Specifically, you can give these patients an injection, which works somewhat fast, but the injection is very invasive — patients don’t like it and clinicians don’t like to administer them. Alternatively, you can give these patients an oral tablet, which is more agreeable to the patients, but then you sacrifice both speed of onset and predictability of drug effect. As such, every time a patient is treated for agitation, a physician has to make a compromise on whether they are going to go with convenience and patient preference, or with speed and predictability. What we believe we have with AZ-004 is a product that will be the first time a physician will not have to make this compromise. That is, a patient with agitation can be treated with AZ-004 and have both rapid speed of onset — we’ve showed speed of onset in our pivotal studies as fast as 10 minutes — and a very predictable reduction in their agitation, all combined in a simple, patient-friendly, easy-to-use inhalation device. I think this finding illustrates the foundation on which Alexza was founded. Even though we are using a well-characterized compound that has had years of safe clinical use, the combination of this compound with our Staccato technology allows us to create a new medicine and, in this particular case, we actually believe we are going to fundamentally change the practice of medicine by the way agitation can be treated with AZ-004.
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