Brain Related Drug Development

ONP-002: A Breakthrough Neurosteroid for Concussion Treatment

ONP-002 is a first-in-class neurosteroid designed to revolutionize the treatment of moderate to severe concussions. Engineered for rapid action and unparalleled brain penetration, ONP-002 aims to address the urgent unmet medical need in traumatic brain injuries.

Understanding Concussion: A Serious Brain Injury

A concussion is a type of traumatic brain injury (TBI) caused by a sudden impact to the head or body, resulting in rapid movement of the brain inside the skull. This can lead to:

  • Chemical imbalances and cellular damage
  • Disruptions in thinking, learning, behavior, and sleep
  • Symptoms that range from mild confusion to severe cognitive impairment

Early intervention is crucial to preventing long-term complications. ONP-002 represents a transformative approach to concussion treatment, targeting the root causes of brain injury for faster recovery and better outcomes.

Download Our Whitepaper: Novel Drug Development to Treat Concussions, An Unmet Medical Need

Why ONP-002?

  • Proven Efficacy: Preclinical studies in animal and cell models demonstrate rapid molecular and behavioral improvements within hours.
  • Superior Safety Profile: Animal studies confirm excellent tolerability and no significant toxicity concerns.
  • Optimized Delivery: Intranasal administration enables fast and targeted distribution to the brain.
  • Cutting-Edge Formulation: A novel spray-dried nanoparticle formulation enhances bioavailability.
  • Field-Ready Solution: Designed for one-time use via an innovative intranasal delivery device.
  • Patented Innovation: Proprietary intellectual property covers its structure, synthesis, and therapeutic application.

How ONP-002 Works

ONP-002 penetrates cells to activate the ONP-002 receptor, found in neurons, glial cells, and the blood-brain barrier. This triggers a cascade of beneficial effects:

  • Reduces inflammation, oxidative stress, and swelling
  • Clears extracellular and intracellular debris to prevent long-term damage
  • Maintains cognitive function without sedation, as it is non-GABAergic

Clinical Development

ONP-002 has successfully completed a Phase I Single and Multiple Ascending Dose (SAD/MAD) safety study, with ONP-002 demonstrating excellent tolerability and no severe adverse events. Oragenics is now advancing preparations for a Phase II clinical trial.