May 3, 2010 / 11:20 AM / 10 years ago

CORRECTED - CORRECTED-UPDATE 3-Raptor's liver disease drug meets mid-stage t

(Corrects paragraph 10 to remove reference to Jeffrey Cohen being the sole analyst covering Raptor)

* Drug reduces level of certain liver enzymes by half

* Study had 11 patients with a progressive liver disease

* Shares up as much as 58 pct (Adds company, analyst comments; updates stock movement)

By Esha Dey

BANGALORE, May 3 (Reuters) - Raptor Pharmaceutical Corp RPTP.O said a mid-stage study of its drug for a progressive form of liver disease met its main goal, sending its shares up as much as 58 percent.

The main goal of the study was to reduce the level of certain liver enzymes by half.

The company is in talks with potential partners to help develop the drug, DR Cysteamine, to treat non-alcoholic steatohepatitis.

It would prefer to go with two separate partners in the United States and Asia, where the disease is quite prevalent, Chief Medical Officer Patrice Rioux told Reuters.

Rioux also said the company is yet to decide on the details of a second mid-stage trial, but expects to enroll around 120 patients in the trial.

“It could be a study in children, or in adults, or both. We don’t know yet,” Rioux added.

Non-alcoholic steatohepatitis (NASH), believed to affect 5 percent to 11 percent of the U.S. population, is the most common cause of chronic liver disease in North America, the company said in a statement.

NASH causes decreased liver function and can lead to cirrhosis, liver failure and end-stage liver disease.

Raptor is also developing DR Cysteamine for genetic disorders like cystinosis and Huntington’s disease.

C.K. Cooper and Co’s Jeffrey Cohen said Monday’s news does not change his “hold” rating on the stock.

“The net-present value of the pipeline is about $2.88,” Cohen said.

“NASH represents a much larger patient population (than cystinosis) so theoretically they would want a larger company that can help with sales and marketing,” he added.

STUDY DATA

The mid-stage study had 11 adolescent patients with non-alcoholic steatohepatitis, who were given oral doses of up to 1,000 mg of Raptor’s drug twice daily for six months, followed by a six-month post-treatment monitoring period.

The patients had at least twice normal levels of two liver enzymes that are often associated with a presence of liver problems.

The patients showed a decline in the level of one enzyme — alanine transaminase (ALT) — during the treatment period, with seven of 11 patients achieving a greater than 50 percent reduction, and in six of 11, the enzyme reduced to within normal range.

Levels of the second enzyme, aspartate aminotransferase (AST), also saw significant improvements with patients seeing 41 percent reduction by the end of the treatment phase.

“While we are very pleased with the substantial impact seen on liver transaminases, we are particularly encouraged by the rapid drug effect we saw during the early phases of the study as well as the sustained liver enzyme reductions following drug withdrawal,” CMO Rioux said.

Shares of the company were up 36 percent at $3.32 in afternoon trade on Nasdaq. They touched a high of $3.88 earlier in the day. (Reporting by Esha Dey in Bangalore; Editing by Maju Samuel, Roshni Menon)

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