Clinical Trials

Date: 2015-10-06

Type of information: Initiation of the trial

phase: 3

Announcement: initiation of the trial

Company: Axovant Sciences (Bermuda - USA - NY)

Product: RVT-101

Action mechanism:

5-HT6-receptor antagonist. RVT-101 is an orally administered, potent antagonist of the 5-HT6 serotonin receptor. Antagonism of the 5-HT6 receptor is a novel mechanism of action that promotes the release of acetylcholine, glutamate and other neurotransmitters thought to improve cognition and function in patients suffering from Alzheimer\'s disease and other forms of dementia. Preclinical and clinical data support a complementary mechanism of action with cholinesterase inhibitors. RVT-101 has been studied in 13 clinical trials involving over 1,250 human subjects with a favorable safety and tolerability profile. Axovant intends to commence a confirmatory phase 3 clinical study testing RVT-101 on a background of donepezil therapy in mild-to-moderate Alzheimer\'s disease patients in the fourth quarter of 2015.

Disease: Alzheimer\'s disease

Therapeutic area: Neurodegenerative diseases

Country: Europe, USA

Trial details:

MINDSET is an international, multi-center, double blind, placebo-controlled study designed to evaluate the safety, tolerability and efficacy of RVT-101 in patients with mild-to-moderate Alzheimer\'s disease. The 24-week trial will compare 35-mg, once-daily oral doses of RVT-101 to placebo in approximately 1,150 patients with mild-to-moderate Alzheimer\'s disease on a stable background of donepezil therapy. The primary efficacy evaluations are the Alzheimer\'s Disease Assessment Scale – cognitive subscale (ADAS-cog) and the Alzheimer\'s Disease Cooperative Study – Activities of Daily Living scale (ADCS-ADL), each of which have been used as endpoints to obtain regulatory approval of currently-marketed Alzheimer\'s disease treatments in the United States and Europe.

Latest news:

* On October 6, 2015, Axovant Sciences announced the first patients screened in MINDSET, a confirmatory global phase 3 study of its lead product candidate, RVT-101. Axovant also announced that the company and the FDA have agreed to a Special Protocol Assessment (SPA) supporting this phase 3 program. The MINDSET trial is designed to confirm the results of a 684-patient international, multi-center, double-blind placebo-controlled study in which patients on a stable background of donepezil therapy receiving 35 mg RVT-101 demonstrated statistically significant improvements on the ADAS-cog and ADCS-ADL as compared to patients receiving donepezil alone. If the MINDSET study is successful, Axovant intends to submit a New Drug Application to FDA by the end of 2017.

Is general: Yes