Neurala Biosciences, a clinical-stage biotechnology firm, has announced the appointment of Dr. Spyros Papapetropoulos as its new Board Chair and Director. This strategic decision aims to infuse the company's leadership with extensive US regulatory and commercial drug development expertise. The move is critically timed as the Australian company prepares to advance its proprietary DMT–harmala product candidates into Phase 2 efficacy studies for mental health and addiction.
A Veteran Leader in CNS Drug Development
Dr. Papapetropoulos is a board-certified neurologist and neuroscientist with over 20 years of distinguished leadership in CNS drug discovery and development. His impressive career includes senior executive roles at Neuphoria Therapeutics, Acadia Pharmaceuticals, and Vigil Neuroscience, as well as leadership positions at industry giants like Biogen, Allergan, and Pfizer. His track record is marked by successfully leading over 20 IND filings and multiple NDA/BLA submissions, resulting in several CNS product approvals and global launches.
Strategic Alignment with Clinical Momentum
This key appointment aligns perfectly with Neurala's recent clinical achievements and upcoming milestones, signaling a new phase of growth. The company recently garnered attention with the publication of its Phase 1 proof-of-concept data in Scientific Reports, a prestigious Nature Portfolio journal. The study highlighted that its standardized DMT–harmala formulation achieved acute effect scores that significantly exceeded those reported in prior psilocybin and LSD studies on validated measures.
Building on this momentum, Neurala is advancing two differentiated product candidates derived from its proprietary chemistry platform. The company is poised to commence a Phase 1 PK/PD study for its lead candidate, NBX-100, at CMAX Clinical Research in Adelaide, with all necessary approvals and contracts secured. Following the availability of pharmacokinetic data to inform dose selection, a $2 million government-funded Phase 2a efficacy study is scheduled to begin.
Advancing a Second-Generation Psychedelic Platform
Neurala's innovative platform is engineered to develop second-generation psychedelic neuromedicines with optimized profiles for regulated medical use. The lead candidate, NBX-100, is a medium-duration oral formulation designed to treat substance use disorders, including alcohol use disorder. Its second candidate, NBX-200, is a short-acting intranasal formulation being developed for chronic depressive illness, offering flexibility for different clinical settings.
In a statement, Dr. Papapetropoulos emphasized that Neurala’s platform represents a compelling scientific and commercial opportunity, positioning its candidates to compete effectively against emerging programs. Dr. Daniel Perkins, Neurala's CEO, stated that the new Chair's experience in advancing programs from development to commercial launch will support disciplined execution. This expertise is considered vital for strengthening the company's position for future capital raising and strategic expansion into the United States.
The strategic appointment of Dr. Spyros Papapetropoulos as Board Chair marks a pivotal moment for Neurala Biosciences, underscoring its commitment to rigorous clinical advancement. His deep expertise in CNS drug development provides the seasoned leadership necessary to guide the company's novel psychedelic therapies through late-stage trials and complex regulatory landscapes. This move positions Neurala to become a significant force in the evolving field of neuromedicine, aiming to deliver new hope for patients with mental health and addiction disorders.