Health and Healthcare

Ocera Therapeutics Rises on Positive Phase 1 Results

Chris Lange

Published: November 17, 2015 11:45 am

Last Updated: January 13, 2020 5:06 pm

Ocera Therapeutics Inc. (NASDAQ: OCRX) was breaking out in Tuesday’s session following positive results from a clinical study. The biopharma company announced positive results from its Phase 1 study of the oral formulation of OCR-002, ornithine phenylacetate, in healthy subjects. OCR-002 exhibited encouraging extended-release properties, demonstrated a desirable pharmacokinetic (PK) profile and was well-tolerated.

For some background: OCR-002 is an ammonia scavenger and has been granted orphan drug designation and Fast Track status by the U.S. Food and Drug Administration (FDA) for the treatment of hyperammonemia and resultant hepatic encephalopathy in patients with acute liver failure and acute-on-chronic liver disease.

At the same time, the results demonstrated a robust, extended-release pattern for all three pilot OCR-002 extended-release formulations, with mean plasma phenylacetate (PAA) concentrations exceeding those achieved with RAVICTI at all time points for at least 12 hours post-dose.

Linda Grais, M.D., president and CEO of Ocera, said:

We are extremely encouraged by both the PAA exposure profiles and urinary PAGN excretion of the extended-release oral forms of OCR-002 in this evaluation, and believe these findings support the potential for convenient twice-daily dosing. The strength of these results and the prior clinical proof of concept established with RAVICTI in preventing hepatic encephalopathy (HE) in patients suffering from liver cirrhosis provide clear validation for the continued development of oral OCR-002 in this indication. Our next step will be to further optimize the formulations to enhance controlled delivery of the drug under various conditions.

So far in 2015, Ocera has vastly underperformed the market, with the stock down about 47% year to date. However over the past 52 weeks, the stock is only down about 38%.

Shares of Ocera were trading up 17.5% at $3.97 Tuesday morning, with a consensus analyst price target of $12.67 and a 52-week trading range of $2.88 to $8.10.

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