La Jolla’s lead drug hits the primary in PhIII, igniting shares as execs hustle to the FDA
Shares of La Jolla Pharmaceutical surged early Monday after the biotech scored a hit on the primary endpoint in its Phase III of LJPC-501, tested in patients with catecholamine resistant hypotension. But there could be some reservations about this drug, which was expected to make a mark on the primary but needed to achieve key secondary endpoints.
70% of the 163 patients tested with their drug achieved a pre-specified blood pressure response, compared to 23% of the 153 patients on a placebo. That’s a statistically significant impact, setting up the biotech’s plans for a regulatory submission at the FDA.
La Jolla’s shares $LJPC rocketed up 72% on the news.
But there was only a trend toward longer survival, with a 22% drop in mortality risk, which may leave some analysts a little dubious about this drug. And the general lack of insight on key secondaries in general raised persistent questions with analysts who have long covered this company.
Back in January, Jefferies Eun Yang noted:
Ahead of LJPC-501 Ph3 data in 1Q17, we spoke to a critical care physician who expects highly likely success on primary endpoint (blood pressure increase), but skeptical on more clinically meaningful exploratory endpoints (urinary output & mortality), similar to our prior experts’ discussions. As we view potential primary outcome success as largely priced in, exploratory endpoints & safety profile would likely be key to meaningful share appreciation.
The drug is a new version of synthetic human angiotensin II, a natural blood pressure regulator.
“We are grateful to the patients, their families and the dedicated medical teams who contributed to this successful study,” said George F. Tidmarsh, MD., PhD, president and chief executive officer of La Jolla. “We also are very appreciative of the FDA’s advice and contributions in the development of LJPC-501 and look forward to meeting with the FDA to discuss our NDA submission planned for the second half of this year.”