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

Our development pipeline currently includes two programs studying synthetic cannabinoid therapeutics across multiple therapeutic areas.

ZYN002 is the first and only synthetic 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 is in Phase 2 clinical development in patients with refractory epilepsy, in patients with osteoarthritis of the knee as well as in patients with Fragile X syndrome. In February 2016, the FDA granted orphan-drug designation of ZYN002 for the treatment of patients with Fragile X syndrome in the US.

ZYN001 is a pro-drug of THC that enables transdermal delivery through the skin and into the circulatory system via a patch. A Phase 1 clinical program for ZYN001 was initiated in the first half of 2017.

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  Epilepsy in Adults with Focal Seizures – STAR 1  Phase 2 Results  July/August 2017
ZYN002 Osteoarthritis – STOP Phase 2 Results July/August 2017
ZYN002  Fragile X Syndrome – FAB-C Phase 2 Results September 2017
ZYN001 Safety and PK Phase 1 Initiation 1H 2017
ZYN001 Fibromyalgia Phase 2 Initiation 2H 2017
ZYN001  Peripheral Neuropathic Pain Phase 2 Initiation 2H 2017

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.