Hyperactivity In La Jolla Pharma Shares As Hypotension Treatment Aces Late-Stage Trial

The capriciousness associated with the biotech space is in the forefront once again with the near doubling in the shares of La Jolla Pharmaceutical Company LJPC on Monday. The shares were on a high in reaction to positive trial results of its treatment option for hypotension.

The Catalyst

La Jolla announced positive top-line results from a late-stage study dubbed ATHOS-3, which evaluated its product candidate LJPC-501 in patients with catecholamine-resistant hypotension, or CRH.

CRH is a life-threatening syndrome in patients with distributive shock, defined as dangerously low blood pressure with adequate cardiac function. These patients cannot achieve mean arterial pressure despite adequate fluid resuscitation and treatment with currently available vasopressors.

LJCP=501 is the company's proprietary formulation of a synthetic human angiotensin II. Angiotensin II, the major bioactive component of the renin-angiotensin system, serves as one of the body's central regulators of blood pressure.

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The Results

The primary efficacy endpoint was patients achieving a pre-specified target blood pressure response. About 70 percent of the LJPC-501-treated patients achieved the primary efficacy endpoint compared to 23 percent for placebo. The company also noted a trend towards longer survival, with 22 percent reduction in mortality risk through day 28.

Elaborating on the safety profile of the product candidate, the company said an independent Data Safety Monitoring Board recommended that the study continue as originally planned.

• Percentage of patients experiencing at least one adverse event was 92 for placebo-treated patients and 87 for LJPC-501-treated patients.
• Percentage of patients who discontinued treatment due to an adverse event is 22 for placebo-treated patients and 14 for LJPC-501-treated patients.

The Study

ATHOS-3 was a multi-center, randomized, double-blind, placebo-controlled Phase 3 clinical trial where 344 patients were randomized across nine countries; 321 of them received study treatment and were included in the primary analysis.

Way Forward

La Jolla said it would present and publish detailed results from the ATHOS-3 study later this year. The company also said it plans NDA submission for the second half of this year.

Analysts Reaction

Sell-side analysts went gaga over the stock, raising their price targets, as they incorporated the development into their models. Suntrust lifted its price target to $57 from $38 and maintains its Buy rating. Meanwhile, JPMorgan raised its price target to $40 from $27 and stayed at Buy.

At last check, La Jolla shares were soaring 85.96 percent to $36, with volumes at 15.92 million, over 79 times their usual turnover.