Ocera Therapeutics Rises on Positive Phase 1 Results

By Chris Lange Updated Jan 13, 5:06PM EST · Published Nov 17, 11:45AM EST

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Ocera Therapeutics Rises on Positive Phase 1 Results — © Thinkstock

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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About the Author Chris Lange →

Chris Lange is a writer for 24/7 Wall St., based in Houston. He has covered financial markets over the past decade with an emphasis on healthcare, tech, and IPOs. During this time, he has published thousands of articles with insightful analysis across these complex fields. Currently, Lange's focus is on military and geopolitical topics.

Lange's work has been quoted or mentioned in Forbes, The New York Times, Business Insider, USA Today, MSN, Yahoo, The Verge, Vice, The Intelligencer, Quartz, Nasdaq, The Motley Fool, Fox Business, International Business Times, The Street, Seeking Alpha, Barron’s, Benzinga, and many other major publications.

A graduate of Southwestern University in Georgetown, Texas, Lange majored in business with a particular focus on investments. He has previous experience in the banking industry and startups.