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Arcturus Therapeutics

  (Redirected from Alcobra)

Arcturus Therapeutics is a preclinical drug delivery and RNA medicines company. The company is focused on the development of UNA Oligomer chemistry and LUNAR® lipid-mediated delivery.

Arcturus Therapeutics
Public company
Traded asNASDAQ: ARCT
IndustryPharmaceutical industry
Founded2013; 6 years ago (2013)
HeadquartersSan Diego, CA, US
ProductsMetadoxine Extended Release (MDX); Abuse Deterrent Amphetamine Immediate Release (ADAIR)
Websitewww.arcturusrx.com

Arcturus Therapeutics is headquartered in San Diego, CA, US.

Contents

Company historyEdit

Founded in 2013 and based in San Diego, Arcturus Therapeutics Ltd. (NASDAQ:ARCT) is an RNA medicines company with enabling technologies – UNA Oligomer chemistry and LUNAR® lipid-mediated delivery. In November 2017, Arcturus merged with Alcobra, an Israeli-based Biotech company focused on the development of new medications to help patients with cognitive disorders, including attention deficit hyperactivity disorder (ADHD) and fragile X syndrome.[1]

Products in developmentEdit

Metadoxine Extended Release (MDX) is the company’s lead investigational product candidate. Metadoxine Extended Release is a monoamine-independent modulator of GABA (gamma-aminobutyric acid) transmission. The mechanism of action does not directly affect dopamine or norepinephrine. The compound is not a psychostimulant. Metadoxine has shown no potential for abuse or addiction in studies completed to date.[2]

ADHDEdit

Alcobra has completed two Phase II trials[3][4] and one Phase III trial of Metadoxine Extended Release (MDX) in adults with ADHD.[5] Alcobra has also completed one Phase II adolescent ADHD study of Metadoxine Extended Release (MDX).[6] In mid-2015, Alcobra began a second Phase III trial of Metadoxine Extended Release (MDX) in adults with ADHD, called the MEASURE study.

Fragile X syndromeEdit

In December 2013, the FDA granted "Orphan Drug" designation to Metadoxine in the treatment of fragile X syndrome.[7] In June 2015, Alcobra completed a Phase II clinical trial of MDX for the treatment of adolescents and adults with fragile X syndrome.[8] In September 2015, the FDA granted “Fast Track” status to Metadoxine Extended Release (MDX) for fragile X syndrome.[9]

ReferencesEdit

  1. ^ Inc., Arcturus Therapeutics,. "Arcturus Therapeutics Announces Completion of Merger with Alcobra Ltd. and Commences Trading on the Nasdaq Global Market". GlobeNewswire News Room. Retrieved 2018-05-06.
  2. ^ "Metadoxine extended release (MDX) for adult ADHD". Alcobra Ltd. 2014. Retrieved 2014-05-07.
  3. ^ Manor, I; Ben-Hayun R; Aharon-Peretz J; Salomy D; Weizman A; Daniely Y; Meggido D; Newcorn JH; Biederman J; Adler LA (2013). "A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy, Safety and Tolerability of Extended-Release Metadoxine in Adults with Attention-Deficit/Hyperactivity Disorder". Journal of Clinical Psychiatry. 73: 1517–1523. doi:10.4088/jcp.12m07767. PMID 23290324.
  4. ^ Manor, I; Rubin J; Daniely Y; Adler LA (2014). "Attention Benefits After a Single Dose of Metadoxine Extended Release in Adults with Predominantly Inattentive ADHD". Postgrad Med. 126: 7–16. doi:10.3810/pgm.2014.09.2795. PMID 25295645.
  5. ^ Weisler, R; Adler LA; Rubin J; Daniely Y; Manor I (2014). "A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Metadoxine Extended Release 1400 mg Compared with Placebo Once Daily in 300 Adults with Attention-Deficit/Hyperactivity Disorder". Missing or empty |url= (help)
  6. ^ "Alcobra's MDX Meets Primary Endpoint in Phase II Safety and Tolerability Clinical Trial in Adolescents With ADHD". Alcobra Ltd. 2015. Retrieved 2015-03-10.
  7. ^ "FDA Grants Orphan Drug Status to Metadoxine in Fragile X Syndrome". Alcobra Ltd. 2013. Retrieved 2013-12-18.
  8. ^ "Alcobra announces results from Phase 2 clinical trial of MDX for Fragile X Syndrome". Alcobra Ltd. 2015. Retrieved 2015-06-24.
  9. ^ "FDA grants fast track designation to Alcobra's MDX for Fragile X Syndrome". Alcobra Ltd. 2015. Retrieved 2015-09-21.