Tue, Nov. 17, 12:47 PM
Tue, Nov. 17, 9:16 AM
Mon, Nov. 16, 5:43 PM
Mon, Nov. 16, 5:28 PM
- Thinly traded nano cap Ocera Therapeutics (NASDAQ:OCRX) jumps 41% after hours on light volume in response to its announcement of positive Phase 1 results for lead product candidate OCR-002 (ornithine phenylacetate), under development for the prevention of hepatic encephalopathy (HE). The open-label, single-dose, five-treatment, five-period crossover study assessed the pharmacokinetics, safety and tolerability of three prototype extended-release oral formulations of OCR-002 compared to an immediate release oral solution formulation of OCR-002 and the ammonia-lowering agent glycerol phenylbutyrate (Horizon Pharma's RAVICTI), a pre-prodrug of phenylacetate, a component of OCR-002.
- The results showed a robust extended-release pattern for all three pilot OCR-002 extended-release formulations, with average plasma phenylacetate (PAA) concentrations exceeding those achieved with RAVICTI, at all time points for at least 12 hours post dose. Also, mean plasma phenylacetylglutamine (PAGN) concentrations and urinary PAGN excretion were greater for all three OCR-002 extended-release dosage forms compared to RAVICTI at an equivalent molar PAA dose. An end product of the ammonia scavenging activity of PAA is PAGN, formed by the conjugation of PAA with glutamine.
- HE is a condition characterized by confusion and altered consciousness brought about by liver failure caused by the accumulation of toxic substances in the blood (e.g. excess ammonia).
- RAVICTI is a nitrogen binding agent cleared by the FDA in February 2013 for the treatment of urea cycle disorders in which sufferers cannot naturally remove enough ammonia from their blood. OCR-002 is also an ammonia scavenger. An IV formulation is under development for the treatment of acute HE in the hospital setting.
- RAVICTI accounted for $33.4M (14.7%) of Horizon's Q3 total revenues of $226.5M.
Wed, Nov. 4, 6:15 PM
Mon, Aug. 3, 4:36 PM
Thu, Apr. 30, 12:05 PM
- Ocera Therapeutics (OCRX -11.3%) Q1 results: Revenues: $31K (-31.1%); R&D Expense: $4.4M (+76.0%); SG&A: $2.3M (-14.8%); Net Loss: ($6.7M) (-28.8%); Loss Per Share: ($0.34) (unch); Quick Assets: $46.1M (-10.0%).
- 2015 Guidance: Cash burn: $28M - $32M; quick assets on hand sufficient to fund operations through 2016.
Thu, Apr. 30, 8:09 AM
Thu, Apr. 2, 12:45 PM
Wed, Apr. 1, 8:39 PM
- The Phase 2b study evaluating Ocera Therapeutics' (NASDAQ:OCRX) lead product, OCR-002, for the treatment of hepatic encephalopathy (HE) is scheduled to be completed by H2 2016, based on an increased target enrollment of 230 patients from the original 140. The increase was part of the recommendations from the independent Data Monitoring Committee following its pre-planned interim analysis of the data. It recommended that the study continue after it determined that it was not futile and no drug-related safety issues were observed.
- The trial, called STOP-HE, is a randomized, double-blind study assessing intravenously-administered OCR-002 in resolving neurocognitive symptoms of acute HE in hospitalized cirrhotic patients with elevated ammonia. The primary efficacy endpoint is time to meaningful clinical improvement.
- OCR-002 (ornithine phenylacetate) is an ammonia scavenger. HE is a reversible neuropsychiatric disorder observed in patients with acute liver failure or chronic liver cirrhosis in whom the metabolic conversion of ammonia to urea fails. Elevated ammonia levels impairs the function of brain cells and can cause cerebral edema and elevated intracranial pressure. OCR-002 directly lowers circulating ammonia levels by enabling alternate metabolic pathways in the muscle and kidneys.
Wed, Mar. 11, 4:06 PM
Thu, Feb. 19, 9:12 AM
Thu, Feb. 19, 9:06 AM
- Thinly-traded nano cap Ocera Therapeutics (NASDAQ:OCRX) is off 17% premarket on higher-than-normal volume in response to its report of top-line results from a 38-patient Phase 2a study evaluating its lead product candidate OCR-002 (ornithine phenylacetate) in patients with upper gastrointestinal bleeding (UGIB) associated with liver cirrhosis.
- OCR-002 demonstrated an acute ammonia lowering effect in plasma and higher urinary excretion of ammonia compared to placebo, but the differences in plasma ammonia levels did not reach statistical significance due, in part, to higher-than-expected variability in plasma ammonia levels. The differences in ammonia secretion, as measured by the metabolite phenylacetyl glutamine, were statistically significant.
- Elevated ammonia levels are associated with certain severe and life-threatening liver disorders.
- The company believes that a higher dose of OCR-002 will show a greater ammonia-lowering effect. A separate trial evaluating a 2x higher dose of OCR-002 (20 g/day) for the treatment of neurocognitive symptoms of acute hepatic encephalopathy in cirrhotic patients with elevated ammonia is ongoing.
Wed, Feb. 18, 5:38 PM
Nov. 24, 2014, 1:29 PM
- Thinly-traded nano cap Ocera Therapeutics (OCRX +15%) rises on a 10x surge in volume albeit on turnover of only 300K. Shares have jumped 25% over the last two trading days but are still down 66% from the 52-week peak of $19.94 on January 16.
- The only recent news was an upgrade by Zacks to "outperform" with a $6.50 price target on November 19.
- Ocera's lead product is OCR-002, an ammonia scavenger being investigated for the treatment of hepatic encephalopathy, currently in Phase 2 development.
Nov. 24, 2014, 12:46 PM
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