Radicle Science retools clinical trials for wellness products

HEALTHTECH: Company Founded to Address Cannabis Efficacy Testing

Wellness products like CBD oil or valerian root are used by millions of people for various health benefits, but official proof of their effectiveness has long been a frustration of producers and consumers alike.

San Diego startup Radicle Science has come up with a solution leveraging a proprietary AI-driven data analytics platform and a virtual, direct-to-consumer (D2C) clinical trial model to validate and predict the effects of health and wellness products and deliver objective health outcome data across diverse populations and conditions.

“By reducing the cost and increasing the speed, we are able to democratize access to clinical trials for pretty much any company,” said Radicle Science Co-Founder and Executive Chair Pelin Thorogood.

Last year, the company which was founded just two years ago in 2020 had “blockbuster” success with revenue in the seven-figure range, Thorogood said, serving customers and brands “that had never had opportunity to conduct clinical trials before because of cost.”

Radicle Science customers include large public companies to startups who use the data from trials assuring retailers, investors and customers by showing validation on how well a product works – “something they were unable to do before,” Thorogood said.

Cannabis Roots

Radicle Science was founded by Thorogood and CEO Dr. Jeff Chen, MD – alums of Cornell University from different generations – who met through a shared interest in proving health benefits of cannabis products.

Chen studied premed at Cornell before transferring to UCLA for a special physician executive training program where students can work on an MD and MBA simultaneously.

“By the time I graduated, I realized there were deep entrenched interests that did not want healthcare reform and I started looking for ways to improve health outside of the healthcare establishment,” Chen said. “I identified cannabis and CBD as the most widely used wellness product in the U.S. with the least amount of evidence due to nearly a century of illegality and research bans.”

At the age of 29, Chen secured funding from UCLA and founded the UCLA Cannabis Research Initiative (CRI) – one of the first cannabis research programs in the world.

It was through UCLA CRI that Chen met Thorogood, who at the time was funding cannabis research with philanthropist Andy Noorda as co-founders of the Wholistic Research & Education Foundation.

Wholistic became the largest private donor to cannabinoid research, starting with a $4.7 million donation to UC San Diego, UCLA and other universities for studies on CBD “to see how these products may help health and wellbeing as well as potentially help disease states like autism,” Thorogood said.

Before co-founding Wholistic, Thorogood worked in data and analytics and was CMA of Web-SideStory, which was ultimately acquired by Adobe, and was CEO of multichannel analytics platform company Anametrix, Inc.

“That was my career until several years ago when due to a family health crisis that required use of opioids for pain management, I was looking for alternative therapies,” she said. “I looked at cannabinoids but realized there was no data on how they work.”

New Model for Clinical Trials

In their work with universities studying cannabis, Thorogood and Chen eventually grew frustrated at how “slow, expensive, and archaic traditional trials are,” Chen said. “We realized we could leverage technology, crowdsourcing, virtualization, artificial intelligence, mobile devices and direct-to-consumer business models to run clinical trials ten times cheaper and faster.”

Another frustration with traditional trials were the use of small data sets made intentionally homogeneous to ensure results have statistical significance.

“We wanted to make sure the size of our studies were much larger and do studies that were representative of the U.S. population, because if you just study white men or a certain age group or children of a certain age group, those results typically don't translate,” Thorogood said.

The two founders started Radicle Science at the beginning of 2020, writing a business plan and raising a pre-seed round in time to start operations in December 2020.

Radicle first identified priority health areas where consumers needed better treatments and landed on pain, sleep disturbance and stress/anxiety and collaborated with professors from several universities to design rigorous clinical trials that could determine if a treatment was effective or not for these conditions.

Next, they built the technology platform capable of running trials in an automated fashion.

“We then crowdsourced volunteers through social media from across all 50 states. They agreed to take a wellness product or placebo – they were blinded and wouldn't know what they received until the end of the study,” Chen said.

Radicle collected data from test subject wearable devices as well as self-reported data and analyzed it using biostatistics and artificial intelligence.

“We can then see the impact of the product and compare it to the impact of the placebo response,” Chen said. “If the impact of the product was significantly better than the impact of the placebo, then we know the product is truly effective. And then with a push of a button we can easily do this all over again and run an entire study on the next product or condition.”

Last year, Radicle executed and completed 25 randomized control trials on over-the-counter cannabinoid products. “We were able to complete these trials with nearly 10,000 Americans in the study, basically collecting likely the largest data set on cannabinoid effectiveness,” Thorogood said.

Radicle's clinical trial approach was approved by the Studies Institutional Review Board with protocols designed with help of researchers from institutions like John’s Hopkins University, UC San Diego, Scripps Research, UCLA and University of Washington. “Amazing researchers who were excited to do it outside of the university setting because they knew they couldn't move as fast,” Thorogood added.

Beyond Cannabis

With its clinical trial model proven for cannabis products, Radicle is moving fast into other markets – and into more fundraising.

Last quarter, Radicle finished a seed round that combined with the company's pre-seed brought the fundraise total to nearly $10 million.

Radicle was also named a 2022 Cool Company by Connect San Diego.

With its fundraise and recognition, Radicle is now “off to the races” and branching into trials for other products such as functional mushrooms and nootropics – so-called “smart drugs” that can boost brain performance – to see how these natural products help with need states like sleep, anxiety, pain, digestion and focus, Thorogood said. ■