Array Biopharma Inc (NASDAQ:ARRY) presented data on ARRY-797 from a Phase II study of the candidate at the 2016 European Society of Cardiology Congress in Rome, Italy.
In the Phase 2 trial, the candidate met its primary endpoint, paving the way for Array to go ahead with preparation for the next stage of clinical trials as the company moves closer to seeking approval for the drug.
Array Biopharma is developing ARRY-797 as a treatment for a rare cardiovascular disease called lamin A/C-related dilated cardiomyopathy that results from a gene mutation. The company said that the success that it achieved with the candidate in Phase 2 study exceeded historical benchmarks that have recently been used as the basis of approvals for drugs targeting rare diseases.
Secondary endpoints met
ARRY-797 also met the secondary endpoints in the Phase II study. Secondary endpoints targeted included patient-reported outcomes and improvements in the function of the left and right ventricles of the heart.
Array Biopharma reported that patients who received ARRY-797 registered improvement in cardiac function after 48 weeks of treatment. ARRY-797 is an oral medicine.
Dosing details and side effects
All the subjects that Array Biopharma enrolled in the Phase II trial of ARRY-797 had been on a range of medications for heart failure. The drug was administered at 100 mg and 400 mg dose levels.
Both doses of the drug were well tolerated. However, most patients exhibited mild to moderate adverse events, which included infection of the upper respiratory tract, acne and stomatitis. ARRY-797 was not thought to be linked to the grade 3/4 adverse events that were exhibited by the subjects taking the treatment.
Four patients dropped out of the study on various accounts, including the issue of adverse events and availability of a heart transplant.
The path to approval
Array Biopharma has held discussions with regulators on the design of a study of the candidate that could pave the way for its marketing approval.
Experts on Wall Street are beginning to see bright prospects for Array Biopharma after the company presented the upbeat study outcomes. Analysts at Jefferies have reiterated their buy rating on the stock of Array Biopharma and lifted their price estimate on the stock to $7 from $6. Shares of Array Biopharma are currently changing hands in the vicinity of $3.6.