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New Interferon Formulations Promise to Eliminate Injections in Multiple Sclerosis Treatment
MARKETWIRE

Jan 12, 2009SAN DIEGO, CAMARKET WIRE
Nerveda Inc. and Aegis Therapeutics LLC today announced preclinical results from their joint collaboration aimed at developing non-injectable formulations of the beta-interferons. The beta interferons, beta-1a (tradename Rebif(R)), and beta 1b (tradenames Betaseron(R) and Betaferon(R)) are closely related injectable protein drugs in the interferon family that are used to treat both the relapsing-remitting and secondary-progressive forms of multiple sclerosis (MS). The beta interferons are currently administered by subcutaneous injection and have been proven clinically to slow the advance of multiple sclerosis and reduce the frequency of attacks. Current worldwide combined annual sales of Rebif(R), Betaseron(R) and Betaferon(R) are approximately $4 Billion.

Because proteins are large and fragile molecules, they cannot be administered orally and are typically administered by injection. They are often subject to instability due to aggregation of the protein molecules -- particularly upon storage and handling at non-refrigerated temperatures. The resulting protein aggregates are more poorly absorbed into the blood stream upon injection due to their increased size, and induce development of circulating antibodies to interferon in patients that reduce the effectiveness of the drug over time.

Leading medical scientists at Johns Hopkins University, expert in the treatment of neurological diseases, in collaboration with Nerveda and Aegis have applied Aegis' Intravail(R) transmucosal absorption enhancement, and ProTek(R) protein stabilization technologies to address these problems and have demonstrated for the first time that the beta interferons can be administered intranasally to prevent nerve damage in preclinical animal models of multiple sclerosis. In addition, the new formulations were shown to reduce or eliminate the immunogenicity of Betaseron(R) and Rebif(R), administered either by injection or intranasally, while substantially increasing stability in a stress test involving constant agitation at elevated temperatures for extended periods of time.

Dr. Edward Maggio, Ph.D., CEO of Aegis Therapeutics, who participated in the research, said, "since interferons will continue to be the foundation of MS therapy, it is critical that non-invasive delivery options for patients be developed." Maggio also indicated, "the reduction in immunogenicity and the increase in stability also address a significant unmet need of the currently available beta-interferon therapies."

Nerveda plans to begin testing the new formulation in clinical trials in early 2009 in collaboration with clinicians and scientists at John Hopkins University Medical Center and other sites.

Interesting. On average it takes a drug 8 years to complete the clinical trial process. There are 90-odd substances being tested for MS that are farther along than this one. It seems like a pretty expensive process to undertake given the extremely high risk that this would be competing against vastly more effective drugs 8 years from now.