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Posted On: 06/13/2018 6:02:36 PM
Post# of 30037
An IND for Eltoprazine was opened with the neurology division of the US FDA in May 2015 that allowed the Company to initiate a multi-center, randomized, placebo-controlled crossover design Phase 2b trial of Eltoprazine in the treatment of PD-LID in the United States and Europe that was put on recruitment hold in September 2015. The European portion of the trial was closed in 2016. The Company is currently preparing to redesign its Phase 2b PD-LID trial into a Phase 3-enabling parallel design clinical trial as a result of the recent approval of Gocovri from Adamas Pharmaceuticals for the treatment of PD-LID. Elto Pharma is in the process of recruiting seasoned management to lead Elto Pharma going forward.
https://www.amarantus.com/news/press-releases...tralia-for
And Dec. Amarantus Provides Comprehensive Corporate Update
In August 2017, the US FDA approved the first-ever treatment specifically for PD-LID: Gycovri® from Adamas Pharmaceuticals. This approval mitigates a key regulatory risk for Eltoprazine by validating that the Unified Dyskinesia Rating Scale (UDysRS) is viewed by the FDA as an acceptable rating scale on which to base approval in PD-LID. The UDysRS contains the primary measures incorporated in the CDRS, as well as additional measures on which the Company believes Eltoprazine is likely to have a favorable impact, based on historical clinical data. In addition, Eltoprazine received orphan drug designation (ODD) in PD-LID in Q1 2016, which improves Eltoprazine's net present value due to tax and other incentives. The FDA reaffirmed Gycovri's ODD post-approval, giving the Company a high-degree of confidence that Eltoprazine will be afforded similar consideration.
Elto Pharma is redesigning the Phase 2b clinical trial for PD-LID as a result of these market developments. Amarantus believes the positive reception by the market for CNS companies such as Adamas Pharmaceuticals, Acadia Pharmaceuticals and Acorda Therapeutics signals significant investor optimism for symptomatic neurological treatment companies, and Amarantus believes Elto Pharma compares favorably.
Eltoprazine in Agitation in Dementia (Alzheimer's) and Adult ADHD
Eltoprazine has also successfully completed Phase 2 trials in Agitation in Dementia and in Adult ADHD. The initial efficacy data generated in Agitation in Dementia demonstrates a statistically significant effect on the Social Dysfunction and Aggression Scale (p<0.05) in the most severely agitated patient population. The next step in Agitation in Dementia is to execute a robust Phase 2 clinical program. The efficacy data generated in Adult ADHD demonstrates positive effects in the ADHD Rating Scale IV (p=0.03), including positive benefits in both the inattention (p=0.003) and hyperactivity (p=0.008) subscales. The next step in Adult ADHD is to execute a pivotal Phase 3 clinical development program.
Market Opportunity for Eltoprazine in PD-LID and Agitation in Dementia (Alzheimer's)
In 2014, there were approximately 188,000 patients suffering from PD LID in the US. Adamas priced Gycovri at $28,000 per year. Taken together, these metrics imply a $3B+ annual....
https://www.amarantus.com/news/press-releases...ate-update
Aloha
https://www.amarantus.com/news/press-releases...tralia-for
And Dec. Amarantus Provides Comprehensive Corporate Update
In August 2017, the US FDA approved the first-ever treatment specifically for PD-LID: Gycovri® from Adamas Pharmaceuticals. This approval mitigates a key regulatory risk for Eltoprazine by validating that the Unified Dyskinesia Rating Scale (UDysRS) is viewed by the FDA as an acceptable rating scale on which to base approval in PD-LID. The UDysRS contains the primary measures incorporated in the CDRS, as well as additional measures on which the Company believes Eltoprazine is likely to have a favorable impact, based on historical clinical data. In addition, Eltoprazine received orphan drug designation (ODD) in PD-LID in Q1 2016, which improves Eltoprazine's net present value due to tax and other incentives. The FDA reaffirmed Gycovri's ODD post-approval, giving the Company a high-degree of confidence that Eltoprazine will be afforded similar consideration.
Elto Pharma is redesigning the Phase 2b clinical trial for PD-LID as a result of these market developments. Amarantus believes the positive reception by the market for CNS companies such as Adamas Pharmaceuticals, Acadia Pharmaceuticals and Acorda Therapeutics signals significant investor optimism for symptomatic neurological treatment companies, and Amarantus believes Elto Pharma compares favorably.
Eltoprazine in Agitation in Dementia (Alzheimer's) and Adult ADHD
Eltoprazine has also successfully completed Phase 2 trials in Agitation in Dementia and in Adult ADHD. The initial efficacy data generated in Agitation in Dementia demonstrates a statistically significant effect on the Social Dysfunction and Aggression Scale (p<0.05) in the most severely agitated patient population. The next step in Agitation in Dementia is to execute a robust Phase 2 clinical program. The efficacy data generated in Adult ADHD demonstrates positive effects in the ADHD Rating Scale IV (p=0.03), including positive benefits in both the inattention (p=0.003) and hyperactivity (p=0.008) subscales. The next step in Adult ADHD is to execute a pivotal Phase 3 clinical development program.
Market Opportunity for Eltoprazine in PD-LID and Agitation in Dementia (Alzheimer's)
In 2014, there were approximately 188,000 patients suffering from PD LID in the US. Adamas priced Gycovri at $28,000 per year. Taken together, these metrics imply a $3B+ annual....
https://www.amarantus.com/news/press-releases...ate-update
Aloha
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