World’s first stress drug derived from cannabis on the way
The first patient has been enrolled in a clinical trial evaluating Nantheia™ ATL5, an investigational drug derived from cannabis meant for Post-Traumatic Stress Disorder.
What you need to know:
- Post-Traumatic Stress Disorder (PTSD) is a mental health disorder that develops in some people who have experienced a shocking, scary, or dangerous event.
- According to experts anyone can develop PTSD at any age. Genes may make some people more likely to develop PTSD than others.
Scientists have announced that the first patient has been enrolled in a clinical trial evaluating Nantheia™ ATL5, an investigational drug derived from cannabis meant for Post-Traumatic Stress Disorder (PTSD).
PTSD is a mental health disorder that develops in some people who have experienced a shocking, scary, or dangerous event. According to experts anyone can develop PTSD at any age. As per the National Center for PTSD in the US, about seven or eight out of every 100 people will experience PTSD at some point in their lives while women are more likely to develop the disorder than men. Genes may make some people more likely to develop PTSD than others.
According to the principal investigator Dr Matthew Rizzo from University of Nebraska Medical Center’s department of neurological sciences, the scientists are excited to have the trial, which has been approved by the Food and Drug Administration, underway “Our collaboration with ANANDA Scientific (a research-focused biotech company) is allowing us to advance evidence-based research into new therapeutics for the large PTSD patient population.”
The researcher explains that Nantheia™ ATL5 is an investigational drug that uses cannabidiol, a chemical in the Cannabis sativa plant, in ANANDA’s proprietary Liquid Structure delivery technology.
“Pre-clinical and initial clinical studies show that ANANDA’s Liquid Structure™ delivery technology (licensed from Lyotropic Delivery Systems (LDS) Ltd in Jerusalem, Israel) enhances the effectiveness and stability of cannabidiol.
Nantheia™ ATL5 is an oral product with 100mg cannabidiol per softgel capsule.”
Cannabidiol is one of 113 identified cannabinoids in cannabis plants, along with tetrahydrocannabinol, and accounts for up to 40 per cent of the plant’s extract.
“Enrolling the first patient in our second PTSD clinical trial is an important milestone for ANANDA’s clinical development program,” said Sohail Zaidi, ANANDA’s Chief Executive Officer.
“We are very pleased to be partnering with the UNMC’s research team in evaluating our promising drug for this very debilitating condition.”
The researchers further disclose that phase II double-blind, placebo-controlled, randomised clinical study is planning to enroll 180 adult participants to provide rigorous evaluation of the efficacy and safety of Nantheia™ ATL5.
According to the US Library of Medicine, the subjects will meet a criteria for PTSD using the Clinician-Administered PTSD Scale .
“Suicidality is assessed using the Columbia Suicide Severity Rating Scale-Revised (CSSRS-R) at all study visits. Baseline psychopharmacotherapy and/or psychotherapy must be stable (unchanged) for 4 weeks prior to enrollment, and should remain unchanged during study treatment.”
They further highlight that serum pregnancy (for subjects of child bearing potential), urine drug screening and comprehensive metabolic panel are completed at every on-site visit.
“Optional consent will be sought from all PTSD and control subjects who agree to complete the procedures. PTSD subjects’ baseline characteristics will be evaluated overall and relative to subjects without PTSD (controls) during a 3-week baseline period prior to randomization (Nantheia ATL5 or placebo [PBO]).”
