A California-based life sciences company has unveiled a cannabis-focused clinical registry.
Juva Life Inc. (Juva) last week announced the launch of the Informed Patient Cannabis Therapy (IMPACT) Registry to evaluate rationally designed cannabis formulations for clinical effect and mode of action.
While a significant amount of pre-clinical, clinical, and anecdotal data surrounding cannabis exists, Juva says that substantial investments and opportunities in the field of study have not produced a real understanding of how cannabis works to properly pair cannabinoid formulations with various conditions.
A New Solution
To address the issue, Juva designed the IMPACT Registry, which incorporates natural product pharmacology, clinical science, and digital learning.
Juma will use FDA-approved practices to confirm the clinical safety and efficacy of formulations derived from the new platform.
“Our mission is to use state of the art life science and data technologies to understand how cannabis works,” says Chemistry for Juva Life VP Sanjeev Gangwas Ph.D. “There is a significant need for new solutions to serious diseases where cannabis may play a role. Our goal is to address these unmet medical needs and when coupled with our novel learning and revenue model, build a durable, important, and valuable company. The months and years ahead represent an extraordinary opportunity as we unlock that enormous potential of cannabis.”
The WCG Institutional Review Board (IRB) approved the IMPACT Registry on August 25, 2020.
Juma later received approval from the IRB for two research facility locations.
The Juva team is working with the facilities regarding protocols, methodologies, and the recruitment of up to 2,000 volunteer patients.
According to Juva, a significant percentage of cannabis patients self-medicate for untreated or inadequately treated pain, which Juva says presents a problem for physicians and regulatory agencies.
A Need For Understanding
Juva says that patients frequently turn to cannabis when conventional drugs fail them, excluding healthcare providers from their decision because they feel that their physicians and care providers lack knowledge of or belief in the cannabis effect.
Juva aims to address the knowledge gap by developing evidence-based products that meet patient and physician needs.
Juva says that the registry is the “first step” in building an integrated technology platform to address serious and unmet medical needs.
The current approach to cannabis research and development is largely empirical, according to Juva, lacking a new method to quantify cannabis’ clinical effects and mode of action compounds.
Juva says that its method of deciphering and evaluating cannabis chemistry is faster, more efficient, and less costly than current practices.
Through the IMPACT Registry, Juva looks to develop an efficient way to standardize formulation development and testing.
Juva says that combining its mode of action knowledge with FDA-approved clinical endpoints will expedite the collection of valuable evidence-based data sets to evaluate pharmacokinetic/pharmacodynamic relationships, engagement, and clinical efficacy.
