Ocera Therapeutics, Inc. (NASDAQ:OCRX) investors should be smiling from ear to ear today after the drug maker disclosed that it will report additional encouraging results from its Phase 2b STOP-HE study of intravenous (IV) OCR-002 in hospitalized patients with Hepatic Encephalopathy (HE) at the Cowen and Company 37th Annual Healthcare Conference at 11:20 AM Eastern Time today.
Ocera shares reacted to the news, jumping over 40% to $0.87 in pre-market trading Wednesday.
“Further analysis of the data from our STOP-HE trial confirms that OCR-002 rapidly and safely lowered ammonia and, importantly, the ammonia reduction correlated statistically with clinical improvement,” said Linda Grais, M.D., Chief Executive Officer of Ocera. “With greater confidence, we believe the most relevant efficacy considerations likely include earlier timing of drug administration, measuring efficacy sooner after drug administration, and administering the appropriate and tolerable dose regimen of OCR-002. We look forward to discussing these data as well as Phase 3 development with FDA later this year.”
“We are very encouraged by the additional study data indicating IV OCR-002 provided clinical benefit over placebo in other parameters as well, such as the Physician Overall Evaluation, Model for End-Stage Liver Disease (MELD) scores, and in renal function as measured by the change from baseline in Blood Urea Nitrogen (BUN) levels,” said Stan Bukofzer, M.D., Chief Medical Officer of Ocera.
Initial STOP-HE results reported in January 2017 included:
- OCR-002 demonstrated a highly statistically significant reduction in ammonia levels over placebo, p=0.028;
- Higher doses (15g, 20g) showed strong evidence of benefit across multiple endpoints;
- Clinical improvement dose trend observed; responder rate increased as dose increased and was superior to placebo at all doses; and
- OCR-002 was safe and well-tolerated; higher doses had a lower percentage of deaths and life threatening adverse events compared to placebo
Additional results to be presented today include:
- Ammonia reduction correlates with clinical improvement, p=0.0006;
- Dose proportional response and pharmacokinetic data indicate some patients were under-dosed;
- Earlier timing of drug administration and efficacy assessment is important:
– Patients who improve within 48 hours are discharged earlier than patients who do not improve within 48 hours;
– Patients on OCR-002 are more likely to respond within 48 hours compared to placebo, p=0.026;
- Pre-defined measures of improvement were statistically significant: ammonia reduction, p=0.017 and Physician overall evaluation, p= 0.026;
- OCR-002 demonstrated improvement in the Model for End-Stage Liver Disease (MELD) scores, p=0.051; and
- OCR-002 showed improvement in renal function as measured by the change from baseline in Blood Urea Nitrogen (BUN) levels, p=0.04
On the ratings front, Ocera Therapeutics has been the subject of a number of recent research reports. In a report issued on January 31, H.C. Wainwright analyst Ed Arce reiterated a Buy rating on OCRX, with a price target of $4.00, which implies an upside of 572% from current levels. Separately, on the same day, JMP’s Liisa Bayko downgraded the stock to Hold.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Ed Arce and Liisa Bayko have a yearly average return of 26.7% and 12.1% respectively. Arce has a success rate of 47% and is ranked #138 out of 4513 analysts, while Bayko has a success rate of 50% and is ranked #490.
Ocera Therapeutics, Inc. is a clinical stage biopharmaceutical company. It engages in development and commercialization of OCR-002 (ornithine phenylacetate0 in intravenous and oral formulations.