The AgriThera Solution

In collaboration with Emory University, AgriThera is leveraging the Emory team’s substantial experience and expertise in drug discovery to develop CBD prodrugs, new chemical entities that metabolize to CBD in the body. These prodrugs are synthesized by attaching benign chemical groups to the CBD molecule, resulting in improved physicochemical properties that would allow for a daily oral pill formulation with reliable blood and brain concentrations.

The target product profile includes high water solubility, suitability for conventional formulation, and improved oral bioavailability and tissue distribution compared to CBD. Preliminary data show that this strategy can produce water soluble, orally available prodrugs that produce more CBD in brain than CBD alone, and are more potent anticonvulsants in animal models of seizures.

Therapeutic opportunities of cannabidiols

Cannabis produces 100+ unique cannabinoids

CBD and THC are the most well characterized

  • CBD is non-hallucinogenic and not associated with the euphoria of cannabis.
  • A formulation of CBD was approved by the FDA as Epidiolex® to treat developmental and epileptic encephalopathy.
  • 50+ ongoing clinical trials for epilepsy, pain, anxiety and other neurological indications.

Native CBD has limitations and liabilities

Low oral bioavailability (6%):

  • Epidiolex is a formulation of sesame seed oil, dosed BID
  • ~3 hour serum half life (T1/2)*

Poor access through the blood brain barrier (BBB)

Adverse reactions:

  • Alternately an inducer and substrates of certain CYP450 enzymes:
    • Drug-Drug interactions (Clobazam, Cyp3a4)
  • Semnolence
  • Gastrointestinal reactions

Significant opportunities for a CBD Prodrug

A Prodrug can yield:

  • Better dosing profile
  • Superior pharmacokinetics
  • Reduced drug-drug interactions
  • Improved patient tolerance
  • 505(b)(2) and Orphan Drug pathways

AGR101

AgriThera’s candidate drug is being developed as a platform beyond treating seizure disorders.

  • Pain
    • 50 Million patients in the U.S. live with chronic pain
    • 80% of these patients have poorly controlled pain
  • Anxiety
    • 40 Million patients in the U.S. have anxiety disorder