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September 4, 2019updated 23 Dec 2019 9:33am

Boehringer says Pradaxa found to be safe for recurrent VTE prevention

Boehringer Ingelheim has reported results from the RE-SPECT CVT study, which investigated the safety and efficacy of Pradaxa (dabigatran etexilate) and dose-adjusted warfarin in cerebral venous and dural sinus thrombosis (CVT) patients.

Boehringer Ingelheim has reported results from the RE-SPECT CVT study, which investigated the safety and efficacy of Pradaxa (dabigatran etexilate) and dose-adjusted warfarin in cerebral venous and dural sinus thrombosis (CVT) patients.

Pradaxa is a non-vitamin K antagonist oral anticoagulant (NOAC).

The study is claimed to be the largest trial performed in patients with CVT, enrolling 120 patients across nine countries.

According to the study data, patients in both treatment arms did not experience recurrent venous thromboembolism (VTE) events or mortality.

The bleeding rate was also observed to be low. One patient on Pradaxa and two subjects treated with warfarin had a major bleed.

“RE-SPECT CVT was the largest trial performed in patients with CVT to date, enrolling 120 patients.”

RE-SPECT CVT Steering Committee chair José Ferro said: “RE-SPECT CVT was the largest trial performed in patients with CVT to date, enrolling 120 patients.

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“The trial showed that the risk of recurrent VTE in CVT patients of mild to moderate severity under anticoagulant therapy with dabigatran for six months was low and associated with few major or clinically relevant bleeding events.”

In a separate development, Boehringer and its partner Zealand Pharma have revealed plans to launch a Phase II clinical trial to test BI 456906, a dual agonist of GLP-1 and glucagon receptors.

Set to be initiated later this year, the dose-finding, proof of concept Phase II trial will involve obese patients and subjects with type 2 diabetes.

The trial is based on the compound’s safety and tolerability, as well as its positive weight loss potential in people with a body mass index (BMI) of up to 40kg/m2.

Boehringer licensed BI 456906 from Zealand, which will receive a milestone payment of €20m at the Phase II trial initiation. The payment is part of the total outstanding €365m potential milestone payments and royalties on future sales.

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