SAN DIEGO, Nov. 7 /PRNewswire-FirstCall/ -- Anadys Pharmaceuticals, Inc. announced today that it has initiated in collaboration with Novartis Pharma A.G (“Novartis”) a new 13-week pre-clinical toxicology study of ANA975 to assess safety and tolerability in animals. The recently initiated study, which utilizes a new crystalline form of ANA975 developed by Novartis, should further the understanding of the toxicology profile of ANA975.
“The Anadys and Novartis joint development team has been working diligently over the summer to gain a better understanding of what occurred in the initial 13-week toxicology study in animals,” said Steve Worland, Ph.D., Anadys’ President, Pharmaceuticals. “While lymphocyte proliferation is an expected consequence of TLR7 activation, we wish to better understand the extent of this proliferation and its reversibility. This new study, which will explore proliferation and reversibility at multiple doses, should provide information helpful to our objective to resume dosing ANA975 in clinical trials.”
In June 2006, Anadys suspended dosing in its ANA975 Phase 1b trial in patients with chronic hepatitis C pending additional analysis of recently obtained information from pre-clinical 13-week toxicology studies in animals. Preliminary analysis of that information revealed various new observations which appear consistent with intense immune stimulation in animals. Subsequently, the ANA975 IND was put on full clinical hold by the U.S. Food and Drug Administration. There have been no serious adverse events in humans during the Phase 1b trial. All adverse events have been mild to moderate and have not posed any safety concerns to date, and there were no clinical findings that contributed to the decision to suspend the Phase Ib trial.
About ANA975
ANA975, which Anadys is developing in collaboration with Novartis, is the oral prodrug of isatoribine, a proprietary Toll-Like Receptor-7 (TLR7) agonist. TLR-7 is a receptor that activates the innate immune system. Activation of innate immunity is known to be an important component of the human immune defense. ANA975 has been administered to more than 90 healthy volunteers in three completed Phase I trials (501, 502, and 503) and 14 HCV infected patients prior to the suspension of the Phase 1b trial (504), without serious adverse events.
About Anadys
Anadys Pharmaceuticals, Inc., www.anadyspharma.com, is a biopharmaceutical company committed to advancing patient care by discovering, developing and commercializing novel small molecule medicines for the treatment of viral diseases and cancer. The Company has core expertise in structure-based drug design coupled with medicinal chemistry and Toll-Like Receptor-based small molecule therapeutics. Anadys’ clinical development programs include ANA380 for the treatment of HBV, currently in mid-stage clinical development, and ANA975 for the treatment of HCV and HBV, which was suspended while in Phase Ib clinical trials due to pre-clinical toxicology observations in animals. The IND covering ANA975 is currently on full clinical hold; however, a new pre- clinical study has been initiated as a step toward the objective to resume the ANA975 clinical program. Overall, Anadys’ therapeutic platform is designed to advance a strong and continual pipeline of drug candidates into the clinic.
Safe Harbor Statement
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 objective to re-initiate ANA975 clinical trials and whether the new toxicology study will provide information necessary to further such objective. Such forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause Anadys’ actual results to be materially different from historical results or from any results expressed or implied by such forward-looking statements. In particular, there is no guarantee that the FDA will lift the clinical hold on the ANA975 IND, that Anadys and Novartis will be able to agree on future development activities for ANA975 or that the clinical development of ANA975 will be able to be resumed. In addition, the results of initial clinical trials may not be predictive of future results, and Anadys cannot provide any assurances that any of its product candidates will not have unforeseen safety issues, will have favorable results in future clinical trials or will receive regulatory approval. Furthermore, Anadys’ results may be affected by risks related to its collaborative relationships with Novartis and LGLS, competition from other biotechnology and pharmaceutical companies, its effectiveness at managing its financial resources, its ability to successfully develop and market products, the level of effort that its collaborative partners devote to development and commercialization of its product candidates, difficulties or delays in its pre-clinical studies or clinical trials, difficulties or delays in manufacturing its clinical trials materials, the scope and validity of patent protection for its products, regulatory developments involving future products and its ability to obtain additional funding to support its operations. These and other factors that may cause actual results to differ are more fully discussed in Anadys’ SEC filings, including Anadys’ Form 10-K for the year ended December 31, 2005 and the “Risk Factors” section of Anadys’ Form 10-Q for the quarter ended September 30, 2006. All forward-looking statements are qualified in their entirety by this cautionary statement. Anadys is providing this information as of this date and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
Anadys Pharmaceuticals, Inc.
CONTACT: Vince Reardon, Sr. Director, Investor Relations & CorporateCommunications, Anadys Pharmaceuticals, Inc., +1-858-530-3653,vreardon@anadyspharma.com
Web site: http://www.anadyspharma.com/
