HAMILTON, Bermuda, Sept. 26, 2016 /PRNewswire/ -- Axovant Sciences Ltd. (NYSE: AXON), a leading clinical-stage biopharmaceutical company focused on the treatment of dementia, today announced that the company has received Fast Track designation for its Investigational New Drug (IND) application for intepirdine in the treatment of dementia with Lewy bodies from the U.S. Food and Drug Administration (FDA).
"We are pleased that FDA has placed a high priority on the development of intepirdine as a potential treatment for dementia with Lewy bodies," stated Dr. Lawrence Friedhoff, Chief Development Officer of Axovant Sciences. "Dementia with Lewy bodies is the second-leading form of progressive dementia and affects over 1 million people in the United States and currently there are no approved treatments for the disease in either the United States or Europe. We believe the HEADWAY-DLB study of intepirdine in dementia with Lewy bodies represents an important step to address the unmet need of patients with this condition."
The ongoing HEADWAY-DLB study will evaluate over a 24-week treatment period the efficacy, safety and tolerability of intepirdine at doses of 70 mg and 35 mg daily in approximately 240 patients with dementia with Lewy bodies. The study permits patients currently receiving stable background therapy for dementia with Lewy bodies to participate.
The agency's Fast Track designation is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.
More information about FDA' Fast Track designation is available at the following address: www.fda.gov/ForPatients/Approvals/Fast/ucm405399.htm
About AxovantAxovant Sciences Ltd. is a leading clinical-stage biopharmaceutical company focused on acquiring, developing and commercializing novel therapeutics for the treatment of dementia. Axovant intends to develop a pipeline of product candidates to comprehensively address the cognitive, functional and behavioral aspects of dementia and related neurological disorders. Our vision is to become the leading company focused on the treatment of dementia by addressing all forms and aspects of this condition.
About HEADWAY-DLBHEADWAY-DLB is a Phase 2b international, multi-center, double-blind, placebo-controlled clinical study designed to evaluate the safety, tolerability and efficacy of intepirdine in patients with dementia with Lewy bodies. The 24-week trial will evaluate once-daily oral doses of 70 mg intepirdine, 35 mg intepirdine, and placebo in subjects with probable dementia with Lewy bodies. The primary efficacy evaluations are Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-Plus) and a computerized cognitive battery.
For more information, please visit www.lewybodystudy.com or e-mail [email protected] or call 646-677-5778.
Forward-Looking StatementsThis press release contains forward-looking statements, including statements regarding Axovant's elements of its clinical development regarding intepirdine and regulatory strategy. Forward-looking statements can be identified by the words "believe," "anticipate," "continue", "estimate", "project," "expect," "plan," "potential," "intends," "will," "would", "could", "should" or the negative or plural of these words or other similar expressions that are predictions or indicate future events, trends or prospects. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: risks associated with the success, cost and timing of our product development activities and clinical trials; the approval and commercialization of our product candidates including intepirdine and nelotanserin; and increased regulatory requirements. These statements are subject to the risk that clinical trial data are subject to differing interpretations, and regulatory agencies, medical and scientific experts and others may not share Axovant's views of the clinical study data. There can be no assurance that the clinical programs for intepirdine will be successful in demonstrating safety and/or efficacy, that we will not encounter problems or delays in clinical development, or that any of our product candidates will ever receive regulatory approval or be successfully commercialized. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Axovant's business in general, see the "Risk Factors" section of our quarterly report on Form 10-Q filed with the Securities and Exchange Commission on August 15, 2016, and other filings that Axovant makes with the SEC from time to time. These forward-looking statements are based on information available to Axovant as of the date of this press release and speak only as of the date of this release. Axovant disclaims any obligation to update these forward-looking statements, except as may be required by law.
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"We are pleased that FDA has placed a high priority on the development of intepirdine as a potential treatment for dementia with Lewy bodies," stated Dr. Lawrence Friedhoff, Chief Development Officer of Axovant Sciences. "Dementia with Lewy bodies is the second-leading form of progressive dementia and affects over 1 million people in the United States and currently there are no approved treatments for the disease in either the United States or Europe. We believe the HEADWAY-DLB study of intepirdine in dementia with Lewy bodies represents an important step to address the unmet need of patients with this condition."
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The ongoing HEADWAY-DLB study will evaluate over a 24-week treatment period the efficacy, safety and tolerability of intepirdine at doses of 70 mg and 35 mg daily in approximately 240 patients with dementia with Lewy bodies. The study permits patients currently receiving stable background therapy for dementia with Lewy bodies to participate.
The agency's Fast Track designation is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.
More information about FDA' Fast Track designation is available at the following address: www.fda.gov/ForPatients/Approvals/Fast/ucm405399.htm
About AxovantAxovant Sciences Ltd. is a leading clinical-stage biopharmaceutical company focused on acquiring, developing and commercializing novel therapeutics for the treatment of dementia. Axovant intends to develop a pipeline of product candidates to comprehensively address the cognitive, functional and behavioral aspects of dementia and related neurological disorders. Our vision is to become the leading company focused on the treatment of dementia by addressing all forms and aspects of this condition.
About HEADWAY-DLBHEADWAY-DLB is a Phase 2b international, multi-center, double-blind, placebo-controlled clinical study designed to evaluate the safety, tolerability and efficacy of intepirdine in patients with dementia with Lewy bodies. The 24-week trial will evaluate once-daily oral doses of 70 mg intepirdine, 35 mg intepirdine, and placebo in subjects with probable dementia with Lewy bodies. The primary efficacy evaluations are Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-Plus) and a computerized cognitive battery.
For more information, please visit www.lewybodystudy.com or e-mail [email protected] or call 646-677-5778.
Forward-Looking StatementsThis press release contains forward-looking statements, including statements regarding Axovant's elements of its clinical development regarding intepirdine and regulatory strategy. Forward-looking statements can be identified by the words "believe," "anticipate," "continue", "estimate", "project," "expect," "plan," "potential," "intends," "will," "would", "could", "should" or the negative or plural of these words or other similar expressions that are predictions or indicate future events, trends or prospects. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: risks associated with the success, cost and timing of our product development activities and clinical trials; the approval and commercialization of our product candidates including intepirdine and nelotanserin; and increased regulatory requirements. These statements are subject to the risk that clinical trial data are subject to differing interpretations, and regulatory agencies, medical and scientific experts and others may not share Axovant's views of the clinical study data. There can be no assurance that the clinical programs for intepirdine will be successful in demonstrating safety and/or efficacy, that we will not encounter problems or delays in clinical development, or that any of our product candidates will ever receive regulatory approval or be successfully commercialized. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Axovant's business in general, see the "Risk Factors" section of our quarterly report on Form 10-Q filed with the Securities and Exchange Commission on August 15, 2016, and other filings that Axovant makes with the SEC from time to time. These forward-looking statements are based on information available to Axovant as of the date of this press release and speak only as of the date of this release. Axovant disclaims any obligation to update these forward-looking statements, except as may be required by law.
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