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Array (ARRY) Presents Positive Cardiovascular Trial Data

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Array BioPharma (ARRY - Free Report) presented results from a phase II study on its pipeline candidate, ARRY-797, at the European Society of Cardiology Congress 2016 in Rome, Italy.

ARRY-797 is an oral, selective p38 mitogen-activated protein kinase inhibitor, which is being evaluated in patients with lamin A/C-related dilated cardiomyopathy (LMNA-related DCM).

Patients enrolled in the trial were randomized to receive twice daily doses of either ARRY-797 100 mg (n=6) or 400 mg (n=6). Results demonstrated an absolute mean change from baseline of 69 meters on the six-minute walk test (6MWT) at week 12, the study's primary endpoint (baseline 6MWT ranged from 246 to 412 meters). In addition, the magnitude of improvement exceeded historical benchmarks for 6MWT, which recently have served as the basis of approval of other drugs in rare diseases.

In addition, treatment with ARRY-797 resulted in sustained improvements in N-terminal pro-brain natriuretic peptide (NT-proBNP), functional capacity and cardiac function through 48 weeks in LMNA-related DCM patients. Results related to the secondary endpoints — echocardiographic measures of left and right ventricular function, and patient-reported outcomes using the Kansas City Cardiomyopathy Questionnaire (KCCQ) — were also favorable.

 

Data also showed that a 400 mg dose of ARRY-797 resulted in higher improvement in functional capacity and cardiac function compared to the 100 mg dose.

Array BioPharma has met with regulatory bodies to discuss the design of a study that could be the basis for a marketing approval. The company is currently evaluating different options to advance the ARRY-797 program — advancing it on its own, partnering on the program for further development and commercialization, or creating a separate company based on this candidate.

We note that Array BioPharma is focused on the discovery, development and commercialization of targeted small-molecule drugs to treat patients suffering from cancer. Five registration studies on three cancer candidates – binimetinib (MEK162), encorafenib (LGX818) and selumetinib are currently underway.  Selumetinib is being developed under a partnership with AstraZeneca, Inc. (AZN - Free Report) .

Shares were up 4.65% on the news.

Array BioPharma currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector include ANI Pharmaceuticals, Inc. (ANIP - Free Report) and Actelion Ltd. . Both the stocks sport a Zacks Rank #1 (Strong Buy).

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