Neuronasal, Inc. Announces Completion of Pilot Study, Receives IND Clearance to Continue into Phase I Trials of mTBI Therapeutic

WEXFORD, PA, USA I November 12, 2020 I Neuronasal, Inc. ("Neuronasal" or the "Company"), a clinical-stage pharmaceutical company developing new treatments for acute mild traumatic brain injury (mTBI) in partnership with ATAI, today announced that it has completed its pilot study intended to show nose-to-brain delivery of N-acetylcysteine (NAC) in healthy volunteers. Additionally, Neuronasal has been granted Investigational New Drug (IND) clearance by the U.S. Food and Drug Administration (FDA) to continue its plans for a Phase I clinical trial, and is doing so in partnership with ATAI Life Sciences.

Concussions and other forms of mTBI represent a significant unmet medical need. With no currently approved treatments, patients often suffer acute symptomatology including headache, nausea, fatigue, depression, anxiety, and irritability. In fact, approximately half of the 2.5 million people who are concussed every year in the United States alone develop long-term cognitive impairment. Also, the ongoing NINDS-funded TRACK-TBI initiative has recently revealed that concussion is associated with substantial increases in the rates of major depressive disorder, post-traumatic stress disorder, and other psychiatric and non-psychiatric conditions.

Neuronasal Announces Completion of Pilot Study Receives IND Clearance to Continue into Phase I Trial of mTBI Therapeutic

Typically, concussions are the result of physical trauma that disrupts brain tissue and blood supply, followed by focal vascular leakage, inflammation, the formation of reactive oxygen species (ROS), and the release of excessive amounts of glutamate. This, in turn, exhausts the pool of intracellular glutathione in brain tissue and induces glutamate-mediated neuro-excitotoxic damage. In more severe cases, neuronal atrophy and necrosis can occur, as well.

Neuronasal's potentially ground-breaking proprietary treatment includes the intranasal delivery of low doses of NAC to patients with acute mTBI. NAC is a well-established compound that has been used safely for decades, mostly as a mucolytic and to treat acute paracetamol intoxication. NAC stimulates the synthesis of glutathione, the most abundant endogenous antioxidant, which is known to prevent oxidative damage to cellular components. In addition, NAC itself has direct antioxidant, anti-inflammatory, and free-radical scavenging effects. Finally, NAC acts as an inhibitory glutamatergic modulator. Each of these mechanisms is important in the context of mTBI.

NAC has the potential to disrupt the deleterious chain of events following mTBI. In soldiers exposed to explosive blast injury, the probability of symptom resolution at 7 days increased from 41.9% to 86.2% when receiving NAC treatment within 24 hours post-blast.

Neuronasal's intranasal approach enables direct nose-to-brain delivery, allowing for significantly lower doses and outpatient treatment. Given its apparent efficacy in disrupting the underlying neurochemical cascade, intranasal NAC has the potential to induce a fundamental shift in the natural course of the condition for hundreds of thousands of people. 

"We are pleased with our pilot trial results," said Thomas I. Bradshaw, Neuronasal's CEO. "Our team is excited to move into Phase I clinical development with the support of the team at ATAI."

"mTBIs are more than just uncomfortable and can result in everything from depression and anxiety to cognitive decline when left untreated," said ATAI's Chief Scientific Officer, Srinivas Rao. ''By developing an early intervention, we stand to disrupt a potentially disastrous disease trajectory.''

About Neuronasal, Inc.

Neuronasal, Inc. is a clinical-stage pharmaceutical company founded in 2015 in response to the clear and growing unmet needs of mTBI patients. Neuronasal leverages existing science, combined with a cutting-edge delivery mechanism, to develop a potentially ground-breaking treatment for mTBI.  This innovation will fill the gap for these patients, as there is currently no approved treatment available. In partnership with ATAI, Neuronasal is using formulations, devices and biomarkers to efficiently develop these new treatments. Neuronasal, Inc. is headquartered in Pennsylvania. For more information, please refer to our slide presentation via the following link: About Neuronasal.

SOURCE: Neuronasal

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