Alexza Pharmaceuticals Inc has identified two new Staccato-based product candidates for development: AZ-008 and AZ-009, which will incorporate the active pharmaceutical ingredient ropinirole, a dopamine agonist, into Alexza’s proprietary Staccato system. The company plans to develop AZ-008 for the acute treatment of restless legs syndrome (RLS) and AZ-009 for hypomobility during “off periods” in Parkinson’s disease (PD) patients.
James V. Cassella, PhD, says in a release: “On the pipeline side, over the last nine months we have conducted a broad review of medical need in major therapeutic areas. Through this process, we identified a number of product concepts that aligned with our Staccato technology. We selected Staccato ropinirole as the basis of the next product candidates planned in our pipeline, based upon our belief of the need for better therapies for patients with RLS or PD. We feel that AZ-008 and AZ-009 may offer these two distinct patient populations an advantage over products available today.”
Alexza believes that there are potential advantages from the co-development of AZ-008 and AZ-009, as the two product candidates may be able to utilize the same preclinical and toxicology program, Investigational New Drug (IND) submission, and initial Phase 1 clinical trial. Beginning with planned Phase 2 clinical studies, Alexza expects to separate the two product candidates into distinct clinical development programs for the two different patient populations.
Alexza used a variety of tools in its new product identification process, including crowd-sourcing and traditional market research methods, and competitive and clinical analyses for each potential program. The new product candidates will be based on the single dose Staccato platform that is currently being produced in Alexza’s commercial production facility as ADASUVE.
Alexza believes AZ-008 could play a role in treating acute and episodic or breakthrough RLS symptoms in patients who may or may not be taking chronic treatment. Alexza believes the benefits of AZ-008 may include: rapidly treating acute symptoms when they occur at night, which may allow patients to calm their legs and go to or get back to sleep; and providing an acute treatment option for patients who are not yet taking chronic treatment and deferring starting chronic, maintenance therapy that can lead to augmentation of RLS symptoms. There were 41% of physicians surveyed in Alexza’s market research (n=114) who see this product candidate as a potential significant improvement over currently available options for treating these symptoms. Alexza believes that rapidly treating the acute symptoms could address a need in RLS patients for whom the acute symptoms can seriously impair quality of life.