Targacept‘s (NASDAQ:TRGT) first quarter dealt the company several blows with a phase 3 clinical trial failure for its lead drug candidate and a missed target in another clinical program.
Failure of depression candidate TC-5214 led to the formal termination of the company’s partnership with AstraZeneca (NYSE:AZN) on that compound. Rights to TC-5214 revert to Targacept and the company will not incur early termination fees. But Targacept must now realign its resources to focus on its other programs, including an experimental Alzheimer’s disease treatment that remains partnered with AstraZeneca.
Winston-Salem, North Carolina-based Targacept releases first-quarter earnings today after the markets close. The failure of TC-5214 led the company to announce a restructuring that included layoffs of nearly half of its workforce. On Targacept’s first-quarter conference call, expect CEO Don deBethizy to talk about the company’s plans on its remaining drug programs and its strategy going forward. With TC-5214 now on the shelf, here’s what Targacept has left in its drug pipeline:
AZD1446: This experimental Alzheimer’s disease treatment is currently in phase 2 clinical trials with drug partner AstraZeneca. The compound emerged from a preclinical partnership between the two companies. Based on the results, AstraZeneca in January agreed to pursue the compound as a potential new Alzheimer’s disease treatment. AstraZeneca is financing and conducting those studies.
AZD3480: Another Alzheimer’s disease candidate that emerged from the AstraZeneca partnership, AZD3480 is in phase 2 clinical trials comparing the compound to Eisai’s blockbuster Alzheimer’s drug Aricept. A previous three-month study was inconclusive, but the company believes it can get different results from a longer clinical study. This second phase 2b study of AZD3480 will last one year.
TC-5619: TC-5619 is a compound that AstraZeneca last year declined to license. Targacept decided to continue clinical development of the compound on its own. Targacept last December started two clinical trials on the compound, one a phase 2b study evaluating its potential to treat symptoms and cognitive dysfunction in patients with schizophrenia. TC-5619 is also in a phase 2 study as an attention-deficit/hyperactivity disorder (ADHD) treatment. Alzheimer’s disease is another disease target that the company is evaluating for TC-5619.
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.
TC-6987: In March, Targacept released top-line results for a separate phase 2 trial studying the compound in diabetes and asthma. TC-6987 missed targets in the diabetes trial. While Targacept initially said the compound met endpoints in the asthma trial, the company later said that a reanalysis showed that the compound hit just one target.
