Startups

Seattle startup raises $9.7M for clinical trial to test inhaled CBD as anxiety treatment

Receptor Life Sciences CEO Mark Theeuwes. (Receptor Photo)

Seattle startup Receptor Life Sciences has raised $9.7 million to move its CBD-based therapeutic candidate for acute anxiety through clinical testing.

The company is developing a dry powdered form of cannabidiol (CBD) paired with an inhaler. The approach delivers the drug quickly to the body in controllable doses.

Cannabidiol is a component of marijuana but became a mainstream therapeutic product in 2018 when the U.S. Food and Drug Administration approved an oral formulation, Epidiolex, for the treatment of certain seizure disorders.

Receptor combines a powdered form of CBD with an inactive compound that helps absorption deep in the lungs. Both the compound and Receptor’s inhaler are components of an inhaled insulin product approved by the FDA.

In late March the company announced that the FDA had given the green light to a phase 1b clinical trial testing the safety and efficacy of the approach in social anxiety disorder. The study is underway.

The candidate product “has the potential to be the first-in-class treatment for acute anxiety disorders,” said Receptor CEO and President Mark Theeuwes in a statement announcing the FDA’s acceptance of Receptor’s IND (investigational new drug) application. The data will potentially guide future studies for other psychiatric and neurological disorders, he said.

The company recently published a study showing that inhalation of its synthetic CBD provided more rapid absorption into the body than an oral formulation. Peak concentration occurred only four minutes after inhalation and resulted in the formation of fewer breakdown compounds in the body.

The new funding will be used to advance the product through early clinical studies. Meanwhile, Receptor is also exploring an oral formulation of cannabidiol for irritability in people with autism spectrum disorder. The capsule formulation uses an FDA-approved oral absorption enhancer (SNAC), which increases absorption six-fold from the gastrointestinal tract compared to solid oral CBD alone, according to company data described in a press release.

(Receptor Image)

The oral agent is being tested in healthy volunteers to identify a formulation to move forward into further clinical development.

Receptor’s leadership has experience developing inhaled therapeutic products.

Theeuwes was previously COO of Engage Therapeutics, which was sold to Belgian drug maker UCB in 2020 for $125 million, with potential for future milestone payments. The deal closed after completion of Engage’s phase 2b study of a drug-device combination for epilepsy.

Theeuwes took over at Receptor last January from previous CEO and co-founder Gregory Wesner, an intellectual property lawyer. Wesner remains on the company’s board of directors. Co-founder and chief scientific officer Andrea Leone-Bay previously worked on inhaled dry powder and oral drug delivery technologies as VP of pharmaceutical R&D at MannKind Corporations.

The other co-founders of the seven-year old company are chief financial officer Traci Carman and former Starbuck’s executive Arthur Rubinfeld.

Dozens of clinical trials by companies and academic centers are testing cannabidiol in various formulations, according to a government database. Trials are testing oral cannabinoids for pain and other conditions, assessing how topical products last and break down in the body, and combining CBD and THC in an aerosol.

Epidiolex is the only cannabis-derived product approved by the FDA, though three synthetic products related to cannabis are approved mainly for severe nausea and vomiting caused by chemotherapy.

Meanwhile, CBD consumer products derived from hemp, present in everything from coffee to lotions, have been legal in the U.S. since 2018. Researchers have expressed safety concerns about contaminants and concentrations of CBD in off-the-shelf products.

Receptor has nine employees and previously raised a $29 million Series A round in 2018. The new Series A-1 funding, announced Thursday, was led by Granite Point Capital. Other investors were not disclosed.



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