Key Developments For Anadys Pharmaceuticals, Inc.
Anadys Pharmaceuticals, Inc. (ANDS.O) (Consolidated Issue listed on NASDAQ Global Market)
Anadys Pharmaceuticals, Inc. Commences Dosing In Phase II Study Of ANA598
Anadys Pharmaceuticals, Inc. announced that dosing has begun in a Phase II trial of ANA598 in patients chronically infected with hepatitis C virus (HCV). The study will evaluate ANA598 over 12 weeks, taken in combination with pegylated interferon-alpha and ribavirin, in treatment naive HCV patients. ANA598 is an investigational, oral, non-nucleoside polymerase inhibitor. In the Phase II study, naive genotype 1 patients will receive ANA598 or placebo in combination with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin, USP) (a current standard of care, or SOC) for 12 weeks at dose levels of 200 mg or 400 mg twice daily (bid), each with a loading dose of 800 mg bid on day one. After week 12, patients will continue to receive SOC. Patients who achieve undetectable levels of virus at weeks 4 and 12 will be randomized to stop all treatment at week 24 or 48. The primary endpoint of the study is the proportion of patients with undetectable virus at week 12 (defined as complete Early Virological Response, or cEVR). Additional endpoints include safety and tolerability as well as the proportion of patients with undetectable virus at week 4 (defined as Rapid Virological Response, or RVR), weeks 24 and 48, and 24 weeks after stopping all treatment (defined as Sustained Virological Response, or SVR). Ninenty patients are planned to be enrolled in this study -- 30 patients receiving ANA598 and 15 receiving placebo at each dose level.
Anadys Pharmaceuticals, Inc. Announces ANA773 Demonstrates Significant Antiviral Response In Early Clinical Trial In Hepatitis C Patients
Anadys Pharmaceuticals, Inc. announced viral load data for the final cohort of hepatitis C patients in a Phase I clinical trial of ANA773, the Company's oral inducer of endogenous interferons that acts via the toll-like receptor 7 (TLR7) pathway. In patients who received 2000 mg ANA773 every other day over 10 days, the mean (+/-SEM) maximal decline in viral load was 1.3 (+/-0.4) log10, compared to a mean maximal decline of 0.3 (+/-0.1) log10 in patients who received placebo (p=0.037). Five of the eight patients who received 2000 mg ANA773 experienced a maximal decline of greater than 1 log, while none of the eight patients who received placebo experienced a decline of greater than 1 log (p<0.001 for the proportion of patients with maximal response greater than 1 log compared to placebo). The mean end-of-treatment decline was 0.6 log10 in patients who received 2000 mg ANA773 compared to 0.1 log10 in patients who received placebo. ANA773 was well-tolerated in patients throughout the course of the study and there were no serious adverse events reported.
Anadys Pharmaceuticals, Inc. Receives FDA Clearance of Phase II Protocol To Study ANA598 In Combination With Interferon-Alpha And Ribavirin In HCV Patients ANA598 To Be Dosed For 12 Weeks
Anadys Pharmaceuticals, Inc. announced the finalization of the protocol for the Company's Phase II trial of ANA598 in combination with pegylated interferon-alpha and ribavirin in hepatitis C patients. Allowance of the protocol has been received from the United States Food and Drug Administration (FDA), and patient dosing is expected to commence within the next several weeks. In the Phase II study, naive genotype 1 patients will receive ANA598 or placebo in combination with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin, USP) (a current standard of care, or SOC) for 12 weeks at dose levels of 200 mg or 400 mg twice daily (bid), each with a loading dose of 800 mg bid on day one. After week 12, patients will continue to receive SOC. Patients who achieve undetectable levels of virus at weeks 4 and 12 will be randomized to stop all treatment at week 24 or 48. The primary endpoint of the study is the proportion of patients with undetectable virus at week 12 (defined as complete Early Virological Response, or cEVR). Additional endpoints include safety and tolerability as well as the proportion of patients with undetectable virus at week 4 (defined as Rapid Virological Response, or RVR), weeks 24 and 48, and 24 weeks after stopping all treatment (defined as Sustained Virological Response, or SVR).
Anadys Pharmaceuticals, Inc. Announces Strategic Restructuring To Focus Operations On Continuing The Advancement Of ANA598
Anadys Pharmaceuticals, Inc. announced announced a strategic restructuring to focus its operations on the development of ANA598, in particular a proposed Phase II study in hepatitis C patients of ANA598 in combination with pegylated interferon-alpha and ribavirin. As part of this restructuring, the Company intends to suspend further development of ANA773 and is reducing its workforce by approximately 40%. Pending the outcome and analysis of data from current cohorts in ongoing studies in hepatitis C and oncology, Anadys intends to manage the ANA773 programs as potential out-licensing opportunities. The Company anticipates the reduction in force to generate annual cash expense savings of between approximately $4.0 million and $5.0 million. The Company estimates that it will incur one-time cash charges of approximately $1.1 million in severance costs and $0.2 million in continuation of benefits and outplacement services. The Company will retain the clinical development infrastructure required to conduct the Phase II study of ANA598, key capabilities directed toward pharmaceutical development and non-nucleosides, and a streamlined administrative staff. Anadys is preparing for the first Phase II trial in hepatitis C patients of ANA598 in combination with interferon-alpha and ribavirin (current standard of care, or SOC) and intends to submit a protocol to the U.S. Federal Drug Administration (FDA) containing the proposed trial design in July 2009.
Anadys Pharmaceuticals, Inc. Announces Pricing of Common Stock and Warrant Offering
Anadys Pharmaceuticals, Inc. announced that it has entered into definitive agreements with institutional investors to raise approximately $17.5 million in gross proceeds in a registered direct offering through the sale of shares of its common stock and warrants. Anadys estimates that net proceeds from the offering will be approximately $16.2 million, after deducting placement agent fees and estimated offering expenses (not including up to $100,000 of related expenses payable to the placement agent). Anadys has entered into subscription agreements with each of these investors pursuant to which it has agreed to sell a total of 8,358,000 units, each unit consisting of one share of common stock and ( one warrant to purchase 0.35 of a share of common stock (or a total of 2,925,300 shares), at a purchase price of $2.09375 per unit.. The shares of common stock and warrants are immediately separable and will be issued separately. The closing of the transaction is scheduled to occur on June 9, 2009. Proceeds from the transaction will be used in the further development of Anadys' ongoing programs, as well as for other general corporate purposes. Cowen and Company, LLC, a subsidiary of Cowen Group, Inc. acted as the exclusive placement agent for the transaction.
