According to ATAI Life Sciences, the FDA has cleared an IND submitted by Neuronasal Inc. for its N-acetylcysteine (NAC). In January 2020, ATAI announced that it had partnered with Neuronasal on development of intranasal NAC for the treatment of mild traumatic brain injury (mTBI, or concussion) and expected a pilot study to begin the next month.
The pilot study has been completed, and the companies are now planning a Phase 1 trial of the nasal spray in healthy volunteers, ATAI said. Neuronasal is using the Aptar UDS system for delivery of the NAC, according to the company’s web site.
ATAI Chief Scientific Officer Srinivas Rao said, “mTBIs are more than just uncomfortable and can result in everything from depression and anxiety to cognitive decline when left untreated. By developing an early intervention, we stand to disrupt a potentially disastrous disease trajectory.”
Neuronasal CEO Thomas Bradshaw added, “We are pleased with our pilot trial results. Our team is excited to move into Phase 1 clinical development with the support of the team at ATAI.”
Read the ATAI Life Sciences press release.
