La Jolla Pharmaceutical (LJPC) shares jumped 21% in early trading on Tuesday following news that pipeline candidate LJPC-1010 demonstrated positive activity in a pre-clinical model of non-alcoholic steatohepatitis (NASH). NASH is similar to alcoholic liver disease but appears in people who drink little or no alcohol. Recall that early this year shares of Intercept Pharmaceuticals (ICPT) rocketed on mid-stage positive results for its own NASH drug, an unmet medical need and one expected to become a multi-billion dollar indication.
LJPC-1010 is a more potent form of GCS-100, the company’s lead drug candidate and a carbohydrate inhibitor of galectin-3. According to the company, -1010 at 50 mg/kg orally showed significant activity in NASH when compared to GCS-100 at 300 mg/kg given orally, which showed atrend towards improvement but did not reach statistical significance. Oral LJPC-1010 was comparable to an equivalent dose of GCS-100 given intravenously.
Additionally, La Jolla announced last week that the FDA had signed off on the launch of a phase 3 clinical trial for LJPC-501, a synthetic angiotensis II, for the treatment of catecholamine-resistant hypotension (CRH). LJPC and FDA agreed that blood pressure was an appropriate primary endpoint for approval in the indication.
LJPC is up 40% in the last 5 days.
Hypotension, or low blood pressure, is life-threatening and is the result of numerous conditions, including most often poor heart function, drug reactions, or septic shock. Though effective, there are patients that are resistant to the current standard of care, catecholamine infusion. In addition, high doses of catecholamines have severe side effects, including cardiac toxicity. CRH is considered an unmet need, with 75,000 to 100,000 patients who suffer from the disorder with a poor prognosis.
La Jolla plans to file an IND and start a phase 1/2 NASH trial in 1H15.
