In August 2019, Thorne announced its joint venture with Onegevity and Tetra Bio-Pharma to create CB2 Therapeutics. Together, the new venture’s focus is leveraging the power of the endocannabinoid system (ECS) using innovative multi-omics and multi-targeted therapeutic options to become a leader in the management of chronic inflammatory conditions. CB2 Therapeutics is developing compounds for chronic inflammatory conditions with high unmet needs or that are poorly served with existing therapies.

Thorne is excited Onegevity and Tetra Bio-Pharma are moving forward with a clinical trial aimed to start immediately this year. The plan is to evaluate the effectiveness of a new drug candidate PPP003 in the prevention or treatment of inflammatory cytokine conditions. PPP003 is a synthetic cannabinoid drug that selectively acts at the type 2 cannabinoid receptor (CB2R).

The plan is to start nonclinical safety studies as soon as possible. The aim of these early investigations are so the scientists can properly identify drug metabolism, pharmacokinetics, cardiovascular and respiratory safety pharmacology, genetic toxicology, and repeat toxicology and establish regulatory requirements. This type of initial research is typical for new drug investigations—solid evidence is required to support how the drug works in the body, the dosing limits, and if genetics or other systems in the body play a role in how one responds to the treatment.

Once safety has been established, human subjects will be enrolled. First, healthy volunteers in Montreal, Quebec will be assessed, then the study will shift to look at cytokine release syndrome in COVID-19 treated and non-treated patients.

What is cytokine release syndrome? Often abbreviated CRS, it is an acute but potentially fatal, systemic inflammatory syndrome characterized by fever and multiple organ dysfunction, triggered by a variety of factors such as infection and certain drugs. Viral infections such as influenza or COVID-19 tend to result in massive T-cell stimulation and increased pro-inflammatory cytokine production.1

Published clinical findings from early COVID-19 patients have shown 10-15% of cases present with acute respiratory distress syndrome (ARDS), which is triggered by CRS or a cytokine storm. With millions of infections worldwide, the ability to control cytokine production can be an important factor in reducing mortality rates.2 

The active molecule in PPP003 has been found to reduce inflammation and dampen pro-inflammatory cytokine release, therefore, PPP003 is to be carefully examined as a candidate drug to help reduce symptoms of acute lung inflammation and immune system dysregulation in at-risk COVID-19 patients.

Tetra will be utilizing blood biomarkers and whole-genome testing as variables for the new drug efficacy testing, and Onegevity will be handling data analytics using its Health Intelligence platform. Doctors can agree the treatment of cytokine storm has become an important part of rescuing severe patients and Tetra and Onegevity hope to help elucidate options for health care professionals treating individuals who require advanced medical attention. In addition, the findings from this research will help to understand the short and long-term systemic effects of patients treated and untreated, specifically monitoring biomarkers and organ effects of CRS, clinical treatments, and outcomes. 

While Thorne will not be playing a role in this specific clinical trial investigation, we will be providing updates to this trial, the findings, and publications from the joint venture. We are proud to see our partnerships involved in such an impactful and clinically meaningful research trial.  

Read the full Press Release announcing this collaboration and stay tuned to Thorne’s Take 5 Daily and Onegevity’s Journal to learn updates and follow the progress of this trial and more.

References

1.     Shimabukuro-Vornhagen A, Gödel P, Subklewe M, et al. Cytokine release syndrome. J Immunother Cancer. 2018;6(1):56.

2.     Zhang C, Wu Z, Li J-W, Zhao H, Wang G-Q. The cytokine release syndrome (CRS) of severe COVID-19 and Interleukin-6 receptor (IL-6R) antagonist Tocilizumab may be the key to reduce the mortality. Int J Antimicrob Agents. March 2020:105954.