Ai Jian migraine drugs successfully achieved the second phase III trial

April 28, 2018 Source: Sina Pharmaceutical

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In February, Aerjian announced the positive results of its third phase clinical trial, ACHIEVE I, in the treatment of migraine, a new drug, which was the first of two key phase 3 clinical trials. A third trial of the drug, ACHIEVE II (UBR-MD-02), also made a breakthrough, further consolidating the company's plan to submit a listing approval in 2019.

Migraine is a neurological disease that affects a wide range. Migraine is estimated to be the third most common epidemic in the world, with 36 million patients in the United States alone. Ubrogepant is a novel oral calcitonin gene-related peptide (CGRP) receptor antagonist currently developed for the treatment of acute migraine. A total of 1,686 migraine patients were enrolled in the trial. The study tested the effects of moderate to severe headaches with 25 mg and 50 mg doses and placebo. The higher dose trial group achieved two common primary endpoints.

Two hours after treatment, pain was relieved in approximately 20% of the two treatment groups, compared with 14% in the placebo group. Nearly 39% of patients receiving a 50 mg dose no longer had annoying migraine-related symptoms after 2 hours, compared with 27% of patients receiving placebo. The 25 mg group showed an improvement of 34%, but this was not statistically significant.

The company also reported four cases of elevated transaminase liver enzymes (three times the upper limit of normal) associated with treatment. However, they found relevant cases in both the placebo and treatment groups, and according to the team of liver experts, this is interpretable and not classified as a side effect of medication.

The previously completed ACHIEVE I trial was a phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate two doses of Ubrogepant (50 mg and 100 mg) for a single migraine attack compared with placebo. Effectiveness, safety and tolerability. The study enrolled 1327 adult American patients with moderate to severe migraine and were randomized to three groups: placebo, 50 mg, and 100 mg.

Studies have shown that the percentage of pain relief achieved by the two doses at 2 hours after starting treatment was significantly higher than in the placebo group. At the same time, the percentage of the most disturbing symptoms associated with migraine (such as photophobia, phobia, or nausea) in both dose groups was significantly higher than in the placebo group two hours after treatment.

Ai Jianzheng competes with Amgen, Biohaven, Novartis, Eli Lilly, Teva and Alder in the CGRP field. But in addition to Biohaven, these companies are developing monoclonal antibodies for injection.

In March, Biohaven's oral new drug Rimegepant succeeded in migraine trials, which was superior to placebo and reached a common primary end point. Studies have shown that the patient's headache symptoms have improved within 8 hours of treatment. Two hours after administration, the proportion of patients who no longer had headaches in the two clinical trials was 19.2% and 19.6%, respectively, while the data from the placebo control group were 14.2% and 12.0%, respectively. Biomeven said, "Rimegepant can achieve similar effects of Ubrogepant, and will not bring about an increase in transaminase." (Sina Medical Compilation / Fan Dongdong)

Article, picture reference source: Allergan's ubrogepant aces second phase 3 migraine trial

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