Alcobra Pharma (ADHD) reports that the Phase 3 clinical trial of MDX in adults with ADHD missed the primary endpoint

Alcobra Pharma reports that the Phase 3 clinical trial of MDX in adults with ADHD missed the primary endpoint :

In this trial, MDX did not meet the primary endpoint of demonstrating a statistically significant difference from placebo in the change from baseline of the investigator rating of the Conners' Adult ADHD Rating Scales (:CAARS). As previously communicated, the top-line data analysis was conducted on the Full Analysis Set (n=283), which includes all randomized subjects with at least one post-baseline efficacy assessment. Consistent with previously conducted studies, MDX was generally well tolerated.

• "We are exceedingly disappointed with these top-line results. In the coming weeks, the Company intends to review the full data set from MEASURE. Consequently, we will evaluate our options and communicate our strategic plan to investors"

Alcobra (ADHD) tumbles on FDA clinical hold

Alcobra (ADHD) announced late yesterday that the FDA has placed a clinical hold on its new drug applications for MDX for ADHD treatment.

Alcobra Ltd. (ADHD) saw its shares get halved on Thursday after the U.S. Food and Drug Administration (FDA) placed a clinical hold on its late-stage trial. Specifically, the Division of Psychiatry Products gave a verbal notice that a full clinical hold had been placed on its Investigational New Drug applications for MDX in attention-deficit/hyperactivity disorder (ADHD) and fragile X syndrome.

The clinical hold affects Alcobra’s ongoing Phase 3 clinical study of MDX in adult patients with ADHD, known as the “MEASURE” study.

The company has not yet received written notice of the clinical hold from the FDA, however, based on verbal communications, the FDA indicated that the clinical hold is due to adverse neurological findings in a pre-clinical study.

The FDA notification was not based on clinical safety data observed in the ongoing MEASURE study, which has enrolled nearly 500 subjects, or previous clinical studies involving MDX.

Alcobra said that it plans to work diligently with the FDA to seek the removal of the clinical hold.

Excluding Thursday’s move, Alcobra has underperformed the broad markets, with the stock down about 26% year to date. Over the past 52 weeks, the stock is down about 22%.

Alcobra (ADHD) : 22-month performance

Alcobra (ADHD)

Description

Alcobra Ltd is an Israel-based Biopharmaceutical company. It focuses on the development and commercialization of a proprietary drug, MG01CI, to treat Attention Deficit Hyperactivity Disorder (ADHD), a common and morbid neuropsychiatric condition in children and adults. Adult ADHD is associated with increased health risks and healthcare costs, higher divorce rates, lower levels of socioeconomic attainment, lower academic achievement, unemployment and work place deficits, increased risks for motor vehicle accidents, greater likelihood of additional psychiatric disorders, increased criminal activity and incarceration, and higher rates of substance use and abuse. MG01CI product has completed phase two studies.

Address

4th Floor 35 Ehad Ha-Am Street
TEL AVIV-YAFO, 65202
Israel

Website links 

www.alcobra-pharma.com

Key stats and ratios

	Q2 (Jun '13)	2012
Net profit margin	-	-
Operating margin	-	-
EBITD margin	-	-
Return on average assets	-	-224.77%
Return on average equity	-	-755.50%
Employees	3

Alcobra (ADHD) began trading on the NASDAQ on 22 May 2013

Alcobra Ltd. (ADHD), an emerging biopharmaceutical company primarily focused on the development and commercialization of a proprietary drug, MG01CI, to treat Attention Deficit Hyperactivity Disorder, visited the NASDAQ MarketSite in Times Square to celebrate its recent initial public offering (IPO), which occurred on May 22, 2013.

6 weeks after IPO