Phase 1 clinical trial results expected on January 31, 2010 (Nasdaq:ACHN)

On December 15, 2009, Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) disclosed some crucial information from the initial results of the second stage of the Phase 1 trial. This trial is being conducted by Achillion Pharma to measure the effectiveness and the safety of the ACH-1625, which is a drug that is being developed by the pharmaceutical company to treat patients who are suffering from Hepatitis C (HCV). The results showed that if a patient receives a monotherapy (that is, a therapy that includes only ACH-1625) for five days, then he or she can experience an average of “3.94 log10 reduction in HCV RNA”. This meant that a treatment with ACH-1625 can significantly improve the conditions of people diagnosed with Hepatitis C virus. It has also been found that patients can tolerate well the doses of ACH-1625. Moreover, the drug ACH-1625 is considered to be completely safe. Achillion Pharmaceuticals plans to disclose other detailed information on the second stage of the Phase 1 trial by January 31, 2010. The company is thinking of arranging a conference with investors. Apart from disclosing information on the second stage of the Phase 1 trial, the company also plans to talk about both stage A and stage B of the trial. Also, the company wants to do the same in the European Association for the Study of Liver Disease (EASL) meeting that will take place in Vienna in April 2010.

The Phase 1 trial was started by Achillion Pharmaceuticals on June 2009. The trial consists of two stages: stage A and stage B. Both these stages have been completed by the pharmaceutical company. The Phase 1 trial is a “randomized, double-blind, placebo-controlled phase” that measured how safe and tolerable the drug ACH-1625 is. Moreover, the trial wanted to find how effective the drug is in combating the fatal HCV. The trial was conducted in Europe. About 54 people participated in the trial. A few of the participants were healthy (that is, they were not infected with HCV) while the others were infected with HCV. These patients were administered double and single doses of ACH-1625 for 5 days.

In September 2009, Achillion Pharmaceuticals confirmed that it had received favorable results from Stage A of the Phase 1 trial. After the announcement, the company started the second stage, which also achieved encouraging results.

Dr. Elizabeth Olek, who is the Chief Medical Officer (CMO) of Achillion Pharmaceuticals, said:

“In addition to the dramatic reduction in viral load after 5 days of monotherapy, ACH-1625 demonstrates slow viral rebound, which is an important differentiating characteristic, as this continued suppression of viral load after discontinuation of the drug may translate into a more durable antiviral response. These positive proof-of-concept results corroborate our findings from pre-clinical studies with ACH-1625, which demonstrated high potency, unique pharmacokinetic properties, and an excellent safety profile.”

Michael Kishbauch, who is the Chief Executive Officer and also the President of Achillion Pharmaceuticals, credited the companies R&D department for favorable results. He said:

“These compelling interim results are very encouraging as we continue to advance the clinical development of this compound for the treatment of HCV. Not only are the results especially robust, but they give us proof-of-concept ahead of schedule. This is a credit to our top-notch research and development team, which deserves recognition for its scientific excellence and tireless efforts.”