Biotech Values

[Double_Bagel]

http://finance.yahoo.com/news/ocera-announce-additional-encouraging-results-130500369.html

"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