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    You are here : Home » MS Research News » Drugs » AZ01

    AZ01

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    Positive results from Phase 1B trial of possible MS drug AZ01

    Allozyne LogoAllozyne, Inc. announced today positive initial results from its multiple ascending dose (MAD) phase IB trial for its lead product candidate, AZ01, a clinical stage, PEGylated form of human interferon beta-1b for the treatment of relapsing-remitting multiple sclerosis (RRMS).

    "We are very encouraged by the MAD study results, which demonstrate AZ01's potential for monthly dosing. AZ01 has the potential to fill an unmet need for MS patients who continue to place high priority on safe, convenient and effective treatment options for this chronic and debilitating disease," said Meenu Chhabra, Allozyne's CEO.

    "This drug candidate is a reflection of the power of Allozyne's Biociphering platform to generate innovative protein therapeutic product candidates. We look forward to the continued development of AZ01 and expect to launch pivotal testing in 2012."

    The MAD study was conducted as a double-blind, placebo controlled study and designed to establish the safety, tolerability, pharmacokinetic and pharmacodynamic profile of AZ01 in normal healthy volunteers. Patients on different doses of AZ01 were examined at either 14 or 28 day dosing intervals. Data from the MAD study indicate that AZ01 has a comparable half-life after each administration and the half-life is two to three times longer than other PEGylated interferon beta therapeutics known currently to be in clinical development.

    In addition to establishing a pharmacokinetic profile, neopterin levels were measured as a pharmacodynamic biomarker for interferon activity. The data indicate a neopterin response that is greater in duration than the PK response thereby suggesting a prolonged biological effect of interferon beta. Overall AZ01 has been well tolerated and subjects dosed experienced typical symptoms associated with interferon beta treatment, most resolving within 24 hours. Additional dosing cohorts are still being evaluated and Allozyne expects the MAD study to be completed by the end of 2011.

    "The data we have seen in the clinic support the potential for monthly treatment with AZ01 and suggest an improved tolerability profile compared to current treatment options," said Ms. Chhabra. "A monthly therapy may increase patient compliance, possibly leading to greater efficacy, as well as decrease of flu like symptoms and injection site reactions compared to existing interferon beta therapies."

    About AZ01 and Multiple Sclerosis Allozyne's lead product candidate, AZ01, is a next-generation long-acting interferon beta for the treatment of RRMS. Allozyne believes AZ01's therapeutic profile has the potential to result in a less frequent dosing regimen, superior tolerability, and greater efficacy over existing therapies.

    Multiple sclerosis (MS) is a chronic inflammatory and degenerative disease of the brain, which leads to severe nerve damage. Symptoms include fatigue, as well as cognitive and visual impairment. Approximately 2.5 million people worldwide suffer from MS. Global sales of therapeutics used to treat RRMS exceeded $9 billion in 2010, with worldwide sales of currently marketed interferons totaling more than $6 billion. Interferons are currently the standard-of-care for first-line therapy in RRMS, with robust safety and efficacy data extending back to 1993, when the first short-acting interferon beta-1b was launched.

    Source: Allozyne (19/10/11)

    AZ01 Interferon β trial for relapsing remitting MS completes

    Allozyne LogoAllozyne, Inc. announced today, the completion of its first Phase IA clinical trial in healthy individuals for AZ01, a PEGylated form of human interferon beta-1b which is being developed for the treatment of relapsing remitting multiple sclerosis.

    The objectives of the Phase IA trial were to assess safety and tolerability profile in addition to defining its pharmacological properties.

    The results demonstrate that single administrations of AZ01 were well tolerated at all dosage levels tested. In addition, drug serum levels and interferon activity biomarkers were maintained well after administration in the highest dose groups indicating that once a month dosing may be a viable treatment regimen to pursue.

    In addition to the possibility of monthly dosing convenience, the data suggests that patients treated with AZ01 will experience a reduction in the days per month with flu-like symptoms and minimal to no injection site reactions. A multiple administration Phase IB trial is underway with results to be announced in mid 2011.

    Allozyne’s President and CEO, Meenu Chhabra stated: “The treatment of MS is a rapidly evolving arena with the advent of orals and big gun immunomodulators in the last 5 years. That said, we are looking to address a specific unmet need in the largest portion of this $9 billion market which is to provide relief to the injection fatigued patient population from frequent dosing, injection site reactions and flu like symptoms. AZ01 offers the promise of a monthly dosing regimen without introducing additional safety risks. Thus, we are encouraged by the Phase IA results thus far and we remain cautiously optimistic about the probability of achieving monthly dosing which is heavily dependent on our manufacturing process. Thus, there will be a significant strategic focus in getting a commercial manufacturing process established in 2011. This will be a key value driver not just for AZ01 but also for our bioconjugation platform. Moreover, the observed AZ01 attributes, coupled with a longstanding interferon beta safety record, suggests that AZ01 will clearly differentiate itself from other late-stage MS therapeutics in development.”

    About AZ01 and Multiple Sclerosis:

    Allozyne’s lead program, AZ01, offers potential advantages over existing therapies through enhanced dosing convenience and superior tolerability to existing agents. Multiple sclerosis (MS) is a chronic inflammatory and degenerative disease of the brain, which leads to severe nerve damage. Symptoms include fatigue as well as cognitive and visual impairment. Approximately 2.5 million people worldwide suffer from MS. Global sales of therapeutics used to treat MS exceeded $9 billion (USD) in 2009, with sales of commercialized interferons (IFN) approximating $6 billion (USD). IFNs are currently the standard-of-care for first-line therapy in MS, with robust safety and efficacy data extending back to 1993 when the first short-acting IFN beta-1b was launched.

    Source: Business Wire ©2011 Business Wire (11/01/11)

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