MINDSET will seek to confirm results of prior study in which RVT-101 demonstrated statistically significant improvements in cognition and function in mild-to-moderate Alzheimer’s disease patients
HAMILTON, Bermuda I October 6, 2015 I Axovant Sciences Ltd. (NYSE: AXON), a leading clinical-stage biopharmaceutical company focused on the treatment of dementia, today announced the first patients screened in MINDSET, a confirmatory global phase 3 study of Axovant’s lead product candidate, RVT-101. Axovant also announced that the company and the U.S. Food and Drug Administration (FDA) have agreed to a Special Protocol Assessment (SPA) supporting this phase 3 program.
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.
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.
“I am grateful for the unwavering efforts of the entire development team that has so rapidly advanced RVT-101 into this final stage of the drug development process,” said Axovant Chief Development Officer Dr. Lawrence Friedhoff, who is leading the RVT-101 development program and previously led the development program for donepezil (brand name Aricept®), the most widely used Alzheimer’s treatment.
“No new compounds have been approved for Alzheimer’s disease in over a decade, and physicians are scrambling to do more for their patients,” said Dr. Gary Small, President of the American Association for Geriatric Psychiatry. “We need well-tolerated, once-daily oral treatments that provide clinically meaningful benefits. The start of the MINDSET study is an important milestone for the field of Alzheimer’s drug development.”
If the MINDSET study is successful, Axovant intends to submit a New Drug Application to FDA by the end of 2017.
To learn more about enrolling in the MINDSET study, please email mindset@axovant.com.
About a Special Protocol Assessment (SPA)
A Special Protocol Assessment (SPA) from the FDA is a binding agreement that the design and planned analysis of a study adequately address the objectives necessary to support a regulatory submission. More information about the FDA’s Special Protocol Assessment process is available at http://www.fda.gov/downloads/Drugs/…/Guidances/ucm080571.pdf.
About RVT-101
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 and other neurotransmitters thought to improve cognition and function in patients suffering from Alzheimer’s disease and other forms of dementia.
RVT-101 is currently being studied in the confirmatory Phase 3 MINDSET study under a Special Protocol Assessment agreement with the FDA. RVT-101 has previously been studied in 13 clinical trials and dosed in over 1,250 human subjects with a favorable safety and tolerability profile. In a 684-patient multinational double-blind placebo-controlled study, RVT-101 was observed to provide statistically significant benefits in cognition and function to patients with mild-to-moderate Alzheimer’s disease.
RVT-101 is an investigational new drug candidate and is not approved for any indication in any markets.
About Axovant
Axovant Sciences Ltd. is a leading clinical-stage biopharmaceutical company focused on the acquisition, development and commercialization of novel therapeutics for the treatment of dementia, a condition characterized by significant decline in mental capacity and impaired daily function. Axovant intends to develop a pipeline of product candidates to comprehensively address the cognitive, behavioral and functional components of dementia, including Alzheimer’s disease.
SOURCE: Axovant Sciences
Post Views: 97
MINDSET will seek to confirm results of prior study in which RVT-101 demonstrated statistically significant improvements in cognition and function in mild-to-moderate Alzheimer’s disease patients
HAMILTON, Bermuda I October 6, 2015 I Axovant Sciences Ltd. (NYSE: AXON), a leading clinical-stage biopharmaceutical company focused on the treatment of dementia, today announced the first patients screened in MINDSET, a confirmatory global phase 3 study of Axovant’s lead product candidate, RVT-101. Axovant also announced that the company and the U.S. Food and Drug Administration (FDA) have agreed to a Special Protocol Assessment (SPA) supporting this phase 3 program.
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.
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.
“I am grateful for the unwavering efforts of the entire development team that has so rapidly advanced RVT-101 into this final stage of the drug development process,” said Axovant Chief Development Officer Dr. Lawrence Friedhoff, who is leading the RVT-101 development program and previously led the development program for donepezil (brand name Aricept®), the most widely used Alzheimer’s treatment.
“No new compounds have been approved for Alzheimer’s disease in over a decade, and physicians are scrambling to do more for their patients,” said Dr. Gary Small, President of the American Association for Geriatric Psychiatry. “We need well-tolerated, once-daily oral treatments that provide clinically meaningful benefits. The start of the MINDSET study is an important milestone for the field of Alzheimer’s drug development.”
If the MINDSET study is successful, Axovant intends to submit a New Drug Application to FDA by the end of 2017.
To learn more about enrolling in the MINDSET study, please email mindset@axovant.com.
About a Special Protocol Assessment (SPA)
A Special Protocol Assessment (SPA) from the FDA is a binding agreement that the design and planned analysis of a study adequately address the objectives necessary to support a regulatory submission. More information about the FDA’s Special Protocol Assessment process is available at http://www.fda.gov/downloads/Drugs/…/Guidances/ucm080571.pdf.
About RVT-101
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 and other neurotransmitters thought to improve cognition and function in patients suffering from Alzheimer’s disease and other forms of dementia.
RVT-101 is currently being studied in the confirmatory Phase 3 MINDSET study under a Special Protocol Assessment agreement with the FDA. RVT-101 has previously been studied in 13 clinical trials and dosed in over 1,250 human subjects with a favorable safety and tolerability profile. In a 684-patient multinational double-blind placebo-controlled study, RVT-101 was observed to provide statistically significant benefits in cognition and function to patients with mild-to-moderate Alzheimer’s disease.
RVT-101 is an investigational new drug candidate and is not approved for any indication in any markets.
About Axovant
Axovant Sciences Ltd. is a leading clinical-stage biopharmaceutical company focused on the acquisition, development and commercialization of novel therapeutics for the treatment of dementia, a condition characterized by significant decline in mental capacity and impaired daily function. Axovant intends to develop a pipeline of product candidates to comprehensively address the cognitive, behavioral and functional components of dementia, including Alzheimer’s disease.
SOURCE: Axovant Sciences
Post Views: 97
