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Metabasis Comments on Positive Data Reported By Valeant Pharmaceuticals From Pradefovir Mesylate Phase 2 Study

Posted on: Tuesday, 19 July 2005, 09:00 CDT

SAN DIEGO, July 19 /PRNewswire-FirstCall/ -- Metabasis Therapeutics, Inc. commented today on the 24-week interim data reported by Valeant Pharmaceuticals International from a Phase 2 study of the oral anti-viral compound, pradefovir. Valeant is evaluating the safety and efficacy of pradefovir for the treatment of compensated chronic hepatitis B. Pradefovir is a pro-drug of adefovir that was that was discovered by Metabasis and uses Metabasis' HepDirect(TM) technology which allows for higher concentrations of the drug in the liver, the primary site of hepatitis B (HBV) replication. Metabasis has licensed pradefovir to Valeant.

The Phase 2 study conducted by Valeant is an open-label, randomized, multiple dose study with 242 patients enrolled at 21 sites in the United States, Taiwan, Singapore and South Korea. Approximately half of the patients had been previously treated ineffectively with other drugs and 70 percent of the patients were HBeAg positive. Patients that have been previously treated ineffectively are considered to be more difficult to treat. The Phase 2 study consists of five treatment groups: pradefovir -- 5, 10, 20 and 30 mg/day, and Hepsera(R) (adefovir dipivoxil) -- 10 mg/day, with an overall treatment duration of 48 weeks.

The interim 24-week data reported by Valeant indicates that pradefovir demonstrated a significant decline in HBV DNA summarized as follows:

Pradefovir Phase 2 - Interim Week 24 Results Mean Log10 HBV DNA Decline From Baseline (Intent-to-Treat Analysis) Week 24 P-Value Baseline Mean Mean Compared HBV DNA Decline to Number of (Log10 in Hepsera Dose Patients copies/mL) HBV DNA Control Hepsera 10 mg QD 50 8.0 -3.66 N/A Pradefovir 5 mg QD 47 7.9 -3.39 0.262 10 mg QD 49 7.9 -4.22 0.012 20 mg QD 48 8.0 -4.33 0.004 30 mg QD 48 8.2 -5.02 <0.001

The interim results have shown no evidence of nephrotoxicity. There were no serious adverse events related to treatment. The most frequently reported adverse events were similar across all treatment groups, including Hepsera. No dose-related trends regarding safety were identified and no events resulted in a patient being withdrawn prematurely from treatment.

Paul Laikind, Ph.D., Metabasis' chairman, president and chief executive officer said, "We couldn't be more pleased with these results. The data reported to us by Valeant show that pradefovir gave a robust and significant reduction in viral load after only 24 weeks of treatment. This promising result coupled with the apparent safety and lack of nephrotoxicity suggests that this product could turn out to have a significant competitive advantage in the marketplace. If the results reported today are confirmed in future studies, pradefovir could provide physicians and patients with a new therapeutic approach that may significantly improve the treatment of this difficult disease."

Mark Erion, Ph.D., executive vice president, research and development said, "The fact that the majority of patients' in this study had failed on previous therapy makes the interim results with pradefovir all the more impressive. Many current treatment medicines have limitations which may include resistance after prolonged use and/or dose-limiting adverse events. We believe that pradefovir, due to its unique liver targeting, may avoid these problems and the findings to date support that belief."

Dr. Laikind stated further, "Beyond the importance of these results for the development of pradefovir, they also help validate Metabasis unique capabilities for discovering and developing important therapeutic agents that target the liver and liver-related pathways. Pradefovir uses our proprietary HepDirect(TM) liver targeting technology and these results strongly support the effectiveness of the HepDirect technology. This bodes well for the other programs and products that employ the HepDirect technology including MB07133, our drug candidate for primary liver cancer that we are currently testing in the clinic, the hepatitis C project we are conducting with Merck and certain metabolic disease targeted candidates we are working on."

The detailed Phase 2 interim results are expected to be submitted by Valeant for presentation at the 56th Annual Meeting of the American Association for the Study of Liver Diseases in November 2005. The Phase 2 trial is expected to be completed later this year. Valeant plans to review the interim results and discuss plans for continued development with the Food and Drug Administration (FDA).

About Hepatitis B

Hepatitis B is a potentially fatal disease that can lead to complications such as cirrhosis and liver cancer. Approximately two billion people worldwide are estimated to have hepatitis B, with 350-400 million people estimated to be chronically infected. According to a recent study, the HBV market currently represents more than $1 billion in annual sales, and is expected to grow to over $2.8 billion by 2012.

Pradefovir and MB07133 are investigational compounds which have not been found by the FDA or any other regulatory agency to be safe or effective in the diagnosis, mitigation, treatment or cure of any disease or illness. They may not be sold or promoted in the United States unless and until FDA has approved their respective New Drug Application. Similar restrictions apply in other countries.

About Metabasis (http://www.mbasis.com)/

Metabasis Therapeutics is a biopharmaceutical company focused on the discovery, development and commercialization of novel small molecule drugs principally to treat metabolic diseases, cancer and certain other diseases linked to pathways in the liver. Metabasis has established a pipeline that includes clinical and preclinical product candidates targeting large markets with significant unmet medical needs. Metabasis has developed several proprietary technologies for use in discovering and optimizing drugs, including the NuMimetic(TM) and HepDirect technologies. Metabasis is continuing to identify and develop new product candidates using its proprietary technologies and expertise.

Forward-Looking Statements:

Statements in this press release that are not strictly historical in nature constitute "forward-looking statements." Such statements include, but are not limited to, references to the efficacy, safety and potential further development of pradefovir and MB07133, as well as the potential and progress of the Company's other clinical and preclinical compounds. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause Metabasis' actual results to be materially different from historical results or from any results expressed or implied by such forward-looking statements. These factors include, but are not limited to, risks and uncertainties related to Metabasis' dependence on Valeant and its other licensees and collaborators for the clinical development and registration of its product candidates, among other things; the progress and timing of clinical trials for Metabasis' product candidates; the ability to duplicate results from early stage clinical trials in later stage trials; serious adverse side effects of, or serious adverse events related to, Metabasis' product candidates or proprietary technologies; difficulties or delays in development, testing, obtaining regulatory approval, producing and marketing Metabasis' product candidates; the potential and progress of preclinical compounds and programs; and other factors discussed in the "Risk Factors" section of Metabasis' Quarterly Report on Form 10-Q for the quarter ended March 31, 2005. All forward-looking statements are qualified in their entirety by this cautionary statement. Metabasis is providing this information as of this date of this release and does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise.

Metabasis Therapeutics, Inc.

CONTACT: Paul Laikind, Ph.D., of Metabasis Therapeutics, Inc.,+1-858-622-5550

Web site: http://www.mbasis.com/

Source: PRNewswire-FirstCall

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