La Jolla Pharmaceutical’s experimental drug to treat a deadly blood pressure condition hit its main goal in a Phase 3 clinical trial, boosting the company’s stock price by more than 75 percent on Monday morning.
San Diego-based La Jolla (NASDAQ: LJPC) is studying its drug LJPC-501 in patients who have dangerously low blood pressure, which can lead to distributed shock, a condition in which tissues and organs don’t receive adequate blood flow. La Jolla developed its drug to treat patients who don’t respond to blood pressure regulating drugs currently administered in the standard of care. In early Phase 3 clinical trial results released this morning, La Jolla said its drug met the primary goal of increasing blood pressure three hours after starting on the drug.
As of this writing, shares in La Jolla were up 76 percent to $35.08 on the news.
La Jolla says that an estimated 500,000 distributed shock cases are diagnosed in the United States each year. Of those cases, approximately 200,000 patients don’t respond to catecholamines, drugs that regulate blood pressure. Half of these patients die within 30 days, the company says. The experimental La Jolla drug is made from a synthetic form of human Angiotensin II, a peptide hormone that causes blood vessels to constrict, which increases blood pressure.
La Jolla conducted the clinical trial under a Special Protocol Assessment, an agreement with the FDA on the size and design of a trial, as well as the “efficacy signals” needed to support approval of the drug. The Phase 3 trial enrolled 344 patients randomized to receive an infusion of La Jolla’s drug or a placebo. La Jolla said that 70 percent of patients treated with its drug hit a pre-specified blood pressure target, compared to just 23 percent of patients who received a placebo. The company also observed a trend of improved survival in the patients treated with its drug.
Following the release of this positive early clinical data, La Jolla now says it plans to file for FDA approval in the second half of 2017. The company says it will present and publish more detailed results from the trial later this year.