Shares of Array BioPharma Inc. (NASDAQ: ARRY) saw a handy gain in Tuesdays session following the announcement of mid-stage results from its cardiomyopathy trial. These trial results were presented at the European Society of Cardiology Congress 2016 in Italy.
For some background, this was a Phase 2 study for ARRY-797, an oral, selective p38 mitogen-activated protein kinase inhibitor, in patients with lamin A/C-related dilated cardiomyopathy (LMNA-related DCM), a rare, degenerative cardiovascular disease caused by mutations in the LMNA gene and characterized by poor prognosis.
A trend for greater improvement in functional capacity and cardiac function were observed with the 400 mg dose level of ARRY-797 compared to the 100 mg dose level. ARRY-797 was well tolerated at both dose levels, with most patients experiencing mild to moderate adverse events, including stomatitis, acne and upper respiratory tract infection.
The company detailed in its report:
The 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). This magnitude of improvement exceeded historical benchmarks for 6MWT that have served as the basis for recent approvals of other drugs in other rare diseases. ARRY-797 administration also 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.
Other secondary endpoints measured including echocardiographic measures of left and right ventricular function and patient-reported outcomes using the Kansas City Cardiomyopathy Questionnaire (KCCQ), both mirrored the favorable improvements seen with the 6MWT.
Calum MacRae, M.D., PhD, Chief of Cardiovascular Medicine at Brigham and Women’s Hospital, Harvard Medical School, commented:
These data demonstrate promising clinical activity of ARRY-797 in patients with LMNA-related DCM, who typically are diagnosed at a young age and who have a poor prognosis with earlier cardiovascular events, more arrhythmias and a more progressive course than patients with undifferentiated DCM. We are encouraged by the trial results which support further study of this treatment paradigm in patients with this devastating condition.
Excluding Tuesday’s move, Array has underperformed the broad markets, with the stock down 18.5% year to date, and over the past 52 weeks the stock is down about 42%. However in just the past six months the stock has been made a run up nearly 30%.
Shares of Array were last seen up 6.4% at $3.66 on Tuesday, with a consensus analyst price target of $8.00 and a 52-week trading range of $2.38 to $6.01.