Our development pipeline includes two lead product candidates, ZYN002 and ZYN001, which are currently being evaluated in five therapeutic indications.

ZYN002 is the first and only pharmaceutically-produced CBD, a non-psychoactive cannabinoid, formulated as a patent-protected permeation-enhanced gel for transdermal delivery through the skin and into the circulatory system. ZYN002 being developed for patients suffering from Fragile X syndrome (FXS), focal seizures, and osteoarthritis. The FDA has granted Zynerba Orphan Drug designation for the use of CBD as treatment of patients with FXS.

ZYN001, a pro-drug of THC that enables transdermal delivery through the skin and into the circulatory system via a patch, is currently in Phase 1 clinical studies.

Development Status and Upcoming Milestones

These timelines are subject to change due to regulatory, clinical and other considerations.


 Upcoming Milestones

Product Study  Key Milestone Timing
ZYN002 Fragile X Syndrome FDA meeting 1Q 2018
Potential pivotal Phase 2/3 program 1H 2018
ZYN002 Osteoarthritis FDA meeting 1Q 2018
Potential pivotal Phase 2/3 program 2018
ZYN002  Epilepsy in adults with focal seizures Outline path forward 1Q 2018
ZYN001 Safety and PK Phase 1 results 1H 2018
ZYN001 Fibromyalgia/Peripheral Neuropathic Pain Phase 2 initiation 2018

Cannabinoids

Cannabinoids are a class of compounds derived from cannabis plants. The two primary cannabinoids contain in cannabis are cannabidiol (CBD) and Δ9-tetrahydrocannabinol (THC).

Cannabinoid  Cannabidiol  Δ9-Tetrahydrocannabinol
 Activity Non-psychoactive, multiple mechanisms Psychoactive, antinociceptive,
agonist of CB1 and CB2 receptors
Indications Being Developed Epilepsy
Osteoarthritis
Fragile X Syndrome
Fibromyalgia
Peripheral Neuropathic Pain
Potential Future Indications Post-Traumatic Stress Disorder
Autoimmune Diseases
Chronic Cancer Pain
Chronic Pain
GI Disorders
Zynerba Asset CBD Gel – ZYN002 THC Pro-Drug Patch – ZYN001
Patent Protection 2030 2031

THC and CBD Safety

Clinical data suggest that THC and CBD have a high therapeutic index with low toxicity.1 In the nabiximols clinical program, dizziness and fatigue were considered very common (> 1/10) adverse events. These occurred in the first four weeks of exposure were mild to moderate and resolved within a few days with continued treatment.2  Nabiximols are not recommended for use in children or adolescents below 18 years of age due to lack of safety and efficacy data. In non-clinical studies, effects were observed at exposures considered in excess of human exposure suggesting little relevance to clinical use.2

 

References
1.
Fine, PG, Rosenfeld, MJ. The Endocannabinoid System, Cannabinoids, and Pain. Rambam Maimodies Med J 2013;4 (4)E0022.

2. Sativex Summary of Product Characteristics, UK 2014.