SEATTLE, WA--(Marketwire - Oct 18, 2011) - ALLOZYNE, 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.
ALLOZYNE is a biopharmaceutical company creating a pipeline of novel protein therapeutic product candidates to treat autoimmune and inflammatory diseases and cancer. ALLOZYNE's current product development efforts are based on its proprietary biocipher™ technology platforms which allow for the union of biological protein engineering and medicinal chemistry in order to create novel and enhanced protein therapeutics.
The technology underlying ALLOZYNE's biocipher™ platforms is comprised of three components:
- the ability to site-specifically modify the amino acid sequence of any protein;
- the ability to insert stable chemical hinges into these modified sites within the protein; and
- the utilization of these hinges to attach bioconjugates such as polymers, toxic drugs, and antibodies.
ALLOZYNE's mission is to leverage its platform technologies to develop best-in-class and first-in-class product candidates customized to optimize safety, efficacy, dosing convenience and drug characteristics that ALLOZYNE believes may lead to enhanced patient compliance and disease modification.