Basilea's antifungal isavuconazole passed phase III clinical trial futility analysis
Basel, Switzerland, January 29, 2010 - Basilea Pharmaceutica Ltd. (SIX:BSLN) announces that based on a futility analysis of the isavuconazole phase III trial for the treatment of invasive Aspergillus infections, the Independent Data Safety Monitoring Board (IDSMB) has recommended the continuation of the study.
The primary goal of this phase III study is to demonstrate statistical non-inferiority of isavuconazole versus the comparator, current standard-of-care voriconazole in the treatment of invasive Aspergillus infections. The futility analysis was included in the clinical trial design to ensure that the trial could be stopped early if it appeared that the study would be eventually unable to demonstrate non-inferiority for isavuconazole. In life-threatening infections such as invasive fungal infections it is standard to ensure that patients receive the most effective treatment at the earliest stage and are not unnecessarily exposed to potentially ineffective investigational drugs. The IDSMB recommendation was based on the analysis of the primary efficacy endpoint of 180 patients.
"Since the data remains blinded, the efficacy results will not be known until the study is completed, however, we are very pleased that the study has successfully passed this important interim assessment point. Regular assessments of safety parameters by the IDSMB have not revealed any major or unexpected safety concerns. With numerous differentiating features over current therapies, isavuconazole has the potential for a best-in-class antifungal," said Dr. Anthony Man, CEO Basilea Pharmaceutica Ltd. "The recruitment of new patients into the phase III clinical program is expected to resume in the first half of 2010 and topline data are anticipated to be available in 2011."
Pre-clinical and clinical data generated to date indicate that isavuconazole has the potential to overcome many of the key limitations of current therapies for the treatment of invasive fungal infections. Isavuconazole shows high bioavailability and provides for a seamless intravenous-oral step-down option. The drug has predictable, linear pharmacokinetics with no relevant food effect, and the potential for fewer drug-drug interactions. The ability to rapidly achieve adequate plasma and tissue concentrations and to maintain these levels long enough to avoid recurrence is essential for the successful treatment of these life-threatening invasive fungal infections. In addition, isavuconazole is highly water-soluble circumventing the need to add potentially kidney-damaging solubulizing agents to the i.v. formulation.
There are three phase III trials currently open investigating isavuconazole, one targeting yeast infections (candidemia and other invasive candida infections), one targeting mold infections (invasive aspergillosis) and a third trial targeting rare molds and renally impaired patients with aspergillosis.
About invasive fungal infections
Invasive fungal infections are life-threatening. Immunocompromized individuals like cancer or transplant patients are at special risk of acquiring fungal infections, mainly caused by Candida and Aspergillus species and associated with mortality rates between 30% and 90%. It has been shown that early treatment with highly effective antifungals reduces patient mortality.
Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland, and listed on the SIX Swiss Exchange (SIX:BSLN). Basilea's integrated research and development operations are currently focused on new antibacterial, antifungal and oncology agents to fight drug resistance and on the development of dermatology drugs. Basilea's products are targeted to satisfy high medical and patient needs in the hospital and specialty care setting.
The company owns a diversified portfolio including two commercialized drugs (Toctino®, ZEFTERA(TM)/ Zevtera(TM)) and one investigational drug (isavuconazole) in phase III clinical development. Toctino® (alitretinoin) is marketed in Denmark, France, Germany, Switzerland and the United Kingdom and is approved in Austria, Belgium, Canada, Finland, Luxemburg, the Netherlands and Spain. Toctino® has been recommended for approval in 16 European countries. Furthermore, a phase III clinical trial on alitretinoin for the treatment of severe chronic hand eczema is ongoing in the U.S.
Ceftobiprole is marketed in Canada under the brand name ZEFTERA(TM) and in Switzerland under Zevtera(TM). Basilea has set up commercial organizations in Canada, France, Germany, the Nordics, Switzerland and the United Kingdom, while it is building sales and marketing organizations in other countries to commercialize alitretinoin and to co-promote ceftobiprole, subject to approval.
This communication expressly or implicitly contains certain forward-looking statements concerning Basilea Pharmaceutica Ltd. and its business. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Basilea Pharmaceutica Ltd. to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd. is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.