New Ph 3 Efficacy data presented for Eptinezumab in Episodic and Chronic Migraine

Alder BioPharmaceuticals announced new one-year efficacy data from the PROMISE 1 Phase 3 clinical trial in patients with episodic migraine and new six-month data from its PROMISE 2 Phase 3 clinical trial in patients with chronic migraine. PROMISE 1 data demonstrates that patients experienced even further reductions in monthly migraine days (MMDs) following the third and fourth quarterly infusions of eptinezumab. PROMISE 2 data shows that patients experienced a reduction of 8.8 monthly migraine days (MMDs) from baseline following the second quarterly infusion of 300 mg of eptinezumab. These results demonstrate a further numerical improvement in efficacy over the first infusion which resulted in a reduction from baseline of 8.2 MMDs in this trial.

“The encouraging and consistent results from the PROMISE 1 trial showing that eptinezumab provided both immediate and long-term efficacy over a period of a year, reinforce our confidence in eptinezumab’s potential to be a meaningful new treatment option for migraine prevention,” said Robert Azelby, chief executive officer of Alder. “These data further validate the significance of our clinical program and underscore Alder’s commitment to transform the treatment paradigm for migraine prevention for patients whose quality of life is severely impacted by this debilitating disease.”

Commenting on PROMISE 2 data, Robert Azelby, chief executive officer of Alder said, “These data further add to the significant body of clinical evidence supporting eptinezumab’s encouraging clinical profile and reinforce our belief in the value it may provide to patients, if approved”. “The robust efficacy shown over the two quarterly infusions of eptinezumab in chronic migraine patients continues to support eptinezumab’s potential as an important treatment option for patients living with this debilitating condition.”

Highlights from PROMISE 1 Trial Following Third and Fourth Eptinezumab Infusions:

• Following the first quarterly infusion, patients treated with 300 mg experienced 4.3 fewer MMDs from a baseline of 8 MMDs, compared to 3.2 fewer MMDs for placebo from baseline (p value = 0.0001). At one year after the third and fourth quarterly infusions, patients treated with 300 mg experienced further gains in efficacy with a reduction of 5.2 fewer MMDs compared to 4.0 fewer MMDs for placebo-treated patients.*
• Approximately, 31 percent of patients achieved, on average per month, 100 percent reduction of migraine days from baseline compared to approximately 21 percent for placebo. This means that almost one-third of patients, on average, experienced monthly migraine freedom when treated with 300 mg of eptinezumab.
• There were no new safety findings observed with the third and fourth quarterly infusions.

Highlights from PROMISE 2 Trial Following First and Second Infusions:

• After the first quarterly infusion, patients dosed with 300 mg of eptinezumab experienced 8.2 fewer MMDs, from a baseline of 16 MMDs, compared to 5.6 fewer MMDs for placebo from baseline (p value <.0001). A further reduction in MMDs was seen following a second infusion; 8.8 fewer MMDs for patients dosed with 300 mg compared to 6.2 fewer MMDs for those with placebo.*
• Approximately 21 percent of patients achieved, on average, 100 percent reduction of MMDs from baseline compared to 9 percent for placebo after two quarterly infusions of 300 mg of eptinezumab.
• 64 percent of patients achieved 50 percent or greater reduction of MMDs from baseline, compared to 44 percent for placebo; and 43 percent of patients achieved 75 percent or greater reduction of MMDs from baseline, compared to 24 percent for placebo after two quarterly infusions.
• There were no new safety findings observed with the second quarterly infusion.

The observed safety profile for PROMISE 1, to date, is consistent with previously reported eptinezumab studies. The most commonly reported adverse events occurring at an incidence of 2.0 percent or greater across all eptinezumab treatment groups and greater than placebo were: upper respiratory tract infection (10.5 percent), nasopharyngitis (common cold) (6.8 percent), fatigue (3.2 percent),  diarrhea (2.3 percent) and oropharyngeal (mouth) pain (2.0 percent).

The observed safety profile for PROMISE 2, to date, is also consistent with previously reported eptinezumab studies. Adverse event rates among eptinezumab-treated subjects were similar to placebo-treated subjects. The most commonly reported adverse events for eptinezumab, occurring at an incidence of 2.0 percent or greater and greater than placebo were: nasopharyngitis (common cold) (7.4 percent), urinary tract infection (2.8 percent), nausea (2.5 percent), arthralgia (2.3 percent), dizziness (2.0 percent), and fatigue (2.0 percent).

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News Source: Alder Website

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