“This is an important milestone for ANANDA’s clinical development program, and we look forward to continuing to work with the NYU Grossman School of Medicine. We are impressed by the scientific rigor and professionalism of the NYU team in getting a cutting-edge program in place to test the efficacy of our very promising drug,” said Sohail R. Zaidi, ANANDA’s President. “The initiation of patient enrollment in this study reinforces our commitment to our goal of improving Health and Wellness empowered by cannabinoid science. This is also an important step in our efforts to provide patients with PTSD with potentially improved therapeutic options.”
This trial is being conducted at NYU Grossman School of Medicine, led by Esther Blessing, MD PhD, Assistant Professor of Psychiatry, and Charles R. Marmar, MD, the Lucius N. Littauer Professor and Chair of Psychiatry. Dr. Marmar, leader of the NYU Langone PTSD Research Program, is the primary investigator of several personalized medicine-based clinical trials of innovative treatments for PTSD and its common comorbidities, using cutting-edge biomarker technologies to understand mechanisms underlying treatment effects.
“We are excited to get this important trial underway. Our collaboration with ANANDA Scientific allows us to progress in the development of evidence-based CBD products for this debilitating condition,” said Dr. Marmar.
The Phase II study is an eight week, double-blind, randomized, placebo controlled study with adaptive dose design evaluating the effect of Nantheia™ A1002N5S on PTSD symptoms and neurocognitive function in 120 patients with PTSD, 50% with comorbid mild TBI. (ClinicalTrials.gov Identifier: NCT04550377)
ABOUT NANTHEIA™ A1002N5S
Nantheia™ A1002N5S is an investigational drug being evaluated for the treatment of PTSD. The drug uses CBD in ANANDA’s propriety 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 CBD. Nantheia™ A1002N5S is an oral product with 50 mg CBD per softgel capsule.
ABOUT PTSD
PTSD, a relatively common disorder that may develop following a traumatic event, has a US lifetime prevalence of 1.3–12.2%, with higher rates (12–20%) in individuals exposed to military combat [1, 2] [3]. Disabling symptoms include intrusive memories of the event, avoidance of reminders, negative cognitions and hyperarousal. In addition, PTSD is associated with neurocognitive impairment, which interacts to worsen PTSD symptoms and impair treatment outcomes [4] [5-7] [8, 9]. Traumatic brain injury (TBI), experienced by up to 35% of veterans returning from the OEF/OIF conflicts [10], is often comorbid with PTSD and increases the risk of PTSD by up to 3-fold [11-14]. TBI history is an important factor in PTSD treatment development: even mild TBI can lead to long-term neurocognitive impairment, as well as persistent post concussive symptoms – many of which are common to PTSD symptoms [12, 14-16]. Current pharmacotherapies, largely repurposed from other indications, do not reliably improve PTSD symptoms or associated neurocognitive impairment in PTSD or TBI [17-19]. Novel, targeted medications that treat these overlapping symptoms in a coordinated simultaneous fashion are urgently needed.
ABOUT ANANDA SCIENTIFIC (www.anandascientific.com)
ANANDA is a leading research-focused biotech company pioneering high-caliber clinical studies evaluating therapeutic targets for cannabinoids. The company employs patented delivery technologies to make cannabinoids and other plant derived compounds highly bioavailable, water soluble, and shelf-life stable and focuses on producing effective, premium quality nutraceutical and pharmaceutical products. Consistent with its strong research-based data, the company also has a growing pipeline of nutraceutical over-the-counter products. The company has successfully launched these products in the US and the UK, with expansion into additional markets such as the EU, China, Australia and Africa planned for the near future. The company is expanding its research base through multiple sponsored research agreements with universities to diversify its technology portfolio.
REFERENCES
- Kessler, R.C., et al., Lifetime prevalence and age-of-onset distributions of DSM-IV disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry, 2005. 62(6): p. 593-602.
- Hoge, C.W., et al., Combat duty in Iraq and Afghanistan, mental health problems, and barriers to care. N Engl J Med, 2004. 351(1): p. 13-22.
- Shalev, A., I. Liberzon, and C. Marmar, Post-Traumatic Stress Disorder. N Engl J Med, 2017. 376(25): p. 2459-2469.
- Hayes, J.P., M.B. Vanelzakker, and L.M. Shin, Emotion and cognition interactions in PTSD: a review of neurocognitive and neuroimaging studies. Front Integr Neurosci, 2012. 6: p. 89.
- Haaland, K.Y., et al., Neurocognitive Correlates of Successful Treatment of PTSD in Female Veterans. J Int Neuropsychol Soc, 2016. 22(6): p. 643-51.
- Aupperle, R.L., et al., Dorsolateral prefrontal cortex activation during emotional anticipation and neuropsychological performance in posttraumatic stress disorder. Arch Gen Psychiatry, 2012. 69(4): p. 360-71.
- Aupperle, R.L., et al., Executive function and PTSD: disengaging from trauma. Neuropharmacology, 2012. 62(2): p. 686-94.
- Nijdam, M.J., et al., Neurocognitive functioning over the course of trauma-focused psychotherapy for PTSD: Changes in verbal memory and executive functioning. Br J Clin Psychol, 2018.
- Morey, R.A., et al., Neural systems for executive and emotional processing are modulated by symptoms of posttraumatic stress disorder in Iraq War veterans. Psychiatry Res, 2008. 162(1): p. 59-72.
- Rigg, J.L. and S.R. Mooney, Concussions and the military: issues specific to service members. PM R, 2011. 3(10 Suppl 2): p. S380-6.
- Langlois, J.A., W. Rutland-Brown, and M.M. Wald, The epidemiology and impact of traumatic brain injury: a brief overview. J Head Trauma Rehabil, 2006. 21(5): p. 375-8.
- Stein, M.B. and T.W. McAllister, Exploring the convergence of posttraumatic stress disorder and mild traumatic brain injury. Am J Psychiatry, 2009. 166(7): p. 768-76.
- Tanev, K.S., et al., PTSD and TBI co-morbidity: scope, clinical presentation and treatment options. Brain Inj, 2014. 28(3): p. 261-70.
- Kaplan, G.B., et al., Pathophysiological Bases of Comorbidity: Traumatic Brain Injury and Post-Traumatic Stress Disorder. J Neurotrauma, 2018. 35(2): p. 210-225.