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Biogen's Plegridy Records Strong First-Year Clinical Results

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By Dan Carroll, The Motley Fool

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Biogen Idec‘s two-year phase 3 Advance trial of relapsing multiple sclerosis drug Plegridy hit its primary endpoint a year in, reducing the annualized relapse rate of patients taking the drug by 36% compared to a placebo, the company announced this week.

The trial also hit a number of secondary endpoints. Patients on Plegridy showed a 38% less risk of 12-week disability progression as compared to a placebo, the company said. The drug also reduced patient relapses by 39% versus the control group. The full first-year results of the trial also showed significant reduction of MS ailments such as brain lesions.

Plegridy’s shown strong safety results so far, with the most serious adverse effects being minor incidents of infections that occurred across all treatment groups.

Gilmore O’Neill, Biogen’s Global Neurology Late Stage Clinical Development Vice President, was quoted as saying, “In the first year of the ADVANCE trial, PLEGRIDY demonstrated strong efficacy. We saw a marked reduction in relapse rate and this was supported by MRI results. If approved, PLEGRIDY will make an important therapeutic option in the injectable treatment segment.”

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The article Biogen’s Plegridy Records Strong First-Year Clinical Results originally appeared on Fool.com.

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Business, Finance, Occupation & Industry

Positive Year One Results from Biogen Idec Phase 3 ADVANCE Trial of PLEGRIDY™ (Peginterferon Beta-1a

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By Business Wirevia The Motley Fool

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Positive Year One Results from Biogen Idec Phase 3 ADVANCE Trial of PLEGRIDY™ (Peginterferon Beta-1a) Presented at AAN Meeting

– Primary and Secondary Endpoints Met After One Year, Including Reductions in Relapses and Disability Progression –

– Additional Data Demonstrate Significant Effects in Decreasing Brain Lesions –

WESTON, Mass.–(BUSINESS WIRE)– Today Biogen Idec (NAS: BIIB) announced the positive, full first-year results from its two-year pivotal Phase 3 ADVANCE study of PLEGRIDY™(peginterferon beta-1a), the company’s investigational candidate for relapsing-remitting multiple sclerosis (RRMS) dosed once every two weeks or every four weeks. These data, presented today at the American Academy of Neurology’s 65th Annual Meeting, indicate that PLEGRIDY significantly reduced multiple sclerosis (MS) disease activity, including relapses, disability progression and brain lesions, compared to placebo at one year.

“These full first-year results provide a more complete picture of PLEGRIDY and its positive effects on the reduction of relapse, disability progression and lesion development,” said Peter Calabresi, M.D., director, the Johns Hopkins Multiple Sclerosis Center. “These data suggest that, if approved, PLEGRIDY may offer the benefit of a less frequent dosing schedule, which would be a meaningful advance for people living with MS.”

Study Results for Two-Week Dosing Arm at Year One:

Primary endpoint:

  • PLEGRIDY met the primary endpoint of reducing annualized relapse rate (ARR) at one year by 36 percent compared to placebo (p=0.0007).

Secondary endpoints:

  • PLEGRIDY reduced the proportion of patients who relapsed by 39 percent compared to placebo (p=0.0003).
  • PLEGRIDY reduced the number of new or newly enlarging T2-hyperintense lesions on brain MRI scans by 67 percent compared to placebo (p<0.0001).
  • PLEGRIDY also demonstrated significant positive effects on disability progression by reducing the risk of 12-week confirmed disability progression, as measured by the Expanded Disability Status Scale (EDSS), …read more
    Source: FULL ARTICLE at DailyFinance