Treating Brain Injury
Profile
Neuronasal Inc. is a late pre-clinical investment opportunity with a novel patent-protected short-term pharmacologic treatment for concussion (“mild traumatic brain injury” or mTBI) with pharmacologic proof-of-principle established in the clinic and a potential annual market of >$4B in the US and EU. Concussion is an unmet medical need with no approved treatment leaving 15-20% of the >2 million/year concussed US patients with persistent symptoms for >4 weeks despite usual care with rest and analgesia.
Technology Overview
Scientific consensus implicates post-concussive intracranial release of reactive oxygen species (ROS), inflammation and excitotoxic reactions as major mediators of mTBI, but proven antioxidant drugs penetrate poorly into the brain from the systemic circulation. Neuronasal has issued and pending patents covering novel pre-clinically-proven intranasal direct nose-to-brain delivery of ROS-quenching drugs such as N-acetyl-cysteine (NAC) that the Department of Defense is interested in taking into clinical trials; this follows their recently published randomized placebo-controlled proof-of-concept study with effective but poorly-tolerated and poorly-absorbed oral NAC megadosing that never-the-less successfully reduced post-concussive symptoms in blast-exposed US soldiers.
Alliances and Collaborations
Neuronasal has a drug development and licensing agreement with Burke Neurological Institute, an affiliate of Weill Cornell Medical School and Weill Cornell Medical School. Neuronal has a co-development and collaboration agreement with BusStim, LLC, a Virtual Biotech Accelerator. This is a group of former Pharma executives with C-level clinical, regulatory and business development experience.
Neuronasal is teaming with a leading novel nose-to-brain pathway and device firm.
Supporting Metrics or Evidence
Experimental traumatic brain injury (TBI) acutely disrupts brain tissue and blood supply releasing a cascade of ROS-mediated tissue damage that is ameliorated by ROS-quenching molecules and drugs.1,2 Intravenous infusion or intraperitoneal injection of NAC increases brain antioxidant content in man3 or laboratory animals.4 Intraperitoneal NAC or ROS-quenching deferoxamine (DFO) ameliorates experimental TBI,5,6 and DFO can reach neuroprotective levels in brain after intra-nasal delivery in rodents.7
1 Corps KN et al. JAMA Neurol. 2015; 72(3):355-362. 2 Roth TL et al. Nature. 2014 January 9; 505(7482):223–228. 3 Holmay MJ et al. Clin Neuropharmacol. 2013; 36(4):103–106. 4 Zhou et al. J Pharmaceut Sci 2015; 104:2619–2626. 5 Eakin K et al. PLoS ONE 9(4): e90617;2014. 6 Zhang L et al. Neurol Sci 2013; 34:639–645. 7 Febbraro F et al. Exp Neurol 2013; 247:45–58
IP Status
NN traumatic brain injury licensed the following
Issued Patent for:
USPTO notice of allowance for: 16/700,588 Use of N-acetylcysteine for treatment of CNS diseases.
Patents APPLIED for:
Use of Magnetic Resonance Spectroscopy to calibrate and select doses, formulations and devices for intranasal administraiton of N-acteylcysteine
- Method for Providing Neuroprotection for Animal Central Nervous System Against Effect of Ischemia, Trauma and Metal Poisoning.
- US 8,568,691 issued 10/29/2013
- EU 1789077 Issued 8/19/2013
- Formulation patent applications related to nose to brain added on top of these base patents.
Current Investors
The company has been funded by founders and ATAI Life.
Current Timeline
- IN NAC in safety dose study which will demonstrate nose to brain delivery of NAC 1.5 years
- Clinical proof of concept trial on Parkinsons patients and athletes 1 years
Management Team Highlights
Tom Bradshaw, CEO has started four companies around university biomedical inventions, two with successful exits and two in clinical trials.
Joe Hulihan, MD, CMO, VP Global Medical Affairs, Group Director CNS Research, Janssen Pharmaceuticals.
Douglas A. Greene, MD, Head of R&D and senior clinical advisor, Chief Scientific Officer, Ikaria Pharmaceuticals, Sr. VP and CMO Sanofi Aventis, Exec VP Clinical Services and Product Development Merck.
Michael Kaufman, VP Administration and Business Development
Recent milestones
Together with Burke Neurological Institute we have filed a broad patents claiming FLAP inhibitors and the use of those inhibitors delivered IN to treat brain injury. We have also sought NIH funding for clinical research related to both mTBI and Parkinsons Disease.