Tag: proof-of-concept

Company News: InDex Pharmaceuticals announces results from COLLECT, a clinical trial of Kappaproct® in the treatment of moderate to severe Ulcerative Colitis

InDex Pharmaceuticals today reported top-line results from the double blind, placebo-controlled clinical study COLLECT. The aim of the COLLECT study was to investigate the therapeutic potential of the Toll-like receptor 9 agonist Kappaproct as an add-on therapy for patients with moderate to severe, chronic active Ulcerative Colitis.

Patients treated with Kappaproct showed statistically significant improvement on symptomatic remission (blood in stool, number of stools), registration remission (clinical remission with concurrent endoscopic remission) and the rate of colectomy. The rate of clinical remission (Rachmilewitz Index) was high in both the Kappaproct and the control group and no statistically significant difference was observed on this measure. Kappaproct was well tolerated and no safety signals compared to the standard of care treatment group were evident.

In the COLLECT study, 131 patients with moderate to severe Ulcerative Colitis with inadequate response to conventional therapy received either Kappaproct or placebo as an add-on to conventional treatment. Concominant use of TNF-α inhibitors was excluded. The study was conducted at 40 sites in seven European countries.

Kappaproct was administrated as two single rectal doses, given at week 0 and week 4. The primary endpoint was clinical remission (Rachmilewitz/CAI score of ≤4) measured at week 12. There was an unexpectedly high remission rate in the control group and there was no statistically significant difference observed on this measure. Statistically significant effects were demonstrated on the secondary endpoints symptomatic remission (blood in stool = none, number of stools weekly <35) at week 4 and 8, on registration remission (Rachmilewitz/CAI score of ≤4, plus an endoscopic Mayo score of 0 or 1) at week 4 as well as on the rate of colectomy at week 22. The patients were followed for one year from the first dose to evaluate long-term efficacy and safety. More information about the study can be found on clinicaltrials.gov.

Company News: BRAIN Publication Demonstrates Significantly Improved Therapeutic Window of Deep Brain Stimulation Using directSTIM™ Directional Electrode

– Study confirms proof-of-concept for innovative DBS lead developed by Aleva Neurotherapeutics

Aleva Neurotherapeutics, a company developing next-generation implants for Deep Brain Stimulation (DBS) in major neurological indications such as Parkinson´s disease, today announced the publication of the results of an intraoperative study with its novel directSTIM™ directional lead. Data were published in the peer-reviewed journal Brain – A Journal of Neurology.*

The data presented in Brain are based on 11 patients with Parkinson´s Disease and 2 patients with essential tremor. In the study, clinical investigators assessed the intraoperative clinical effect of directional stimulation using Aleva’s directSTIM™ lead. This device features two rings consisting of three independent electrodes each. The angular position of the electrodes allows stimulation at 0°, 120° and 240° directions Directional stimulation was tested at the target determined for the permanent lead. The clinical investigators compared the therapeutic window (defined as the electrical current at which side-effects occur minus the current at which a significant therapeutic effect is observed) of directional and classical stimulation. Compared to omnidirectional stimulation, the therapeutic window in the best direction was 41% wider. Furthermore, the current threshold producing meaningful therapeutic effects in the best direction was 43% lower than in omnidirectional stimulation. No complication was observed due to the insertion and removal of the directional lead or during testing.

* Reference:

Pollo C, Kaelin-Lang A, Oertel MF, Stieglitz L, Taub E, Fuhr P, Lozano AM, Raabe A, Schüpbach M – Directional deep brain stimulation: an intraoperative double-blind pilot study. Brain 2014; doi:10.1093/brain/awu102.