1st-of-its-kind fentanyl antibody treatment begins human trials as overdose deaths rise

SAN JOSE, Calif. -- A drugmaker funded by a South Bay company is about to begin human testing on a first-of-its-kind fentanyl antibody treatment as fentanyl remains the leading cause of death for people ages 18 to 45 and the cause of 90% of overdose fatalities.

Experts say more options are needed to prevent loss of life.

"Despite the availability of things like narcan, which is a rescue medication, we continue to see an all-time high of overdoses throughout the country," Cessation Therapeutics CEO Tracy Woody said. "Our big news is we have something that we think will help address this public health crisis."

Born out of San Jose-based investment firm Altamont Pharmaceutical Holdings, Cessation Therapeutics has developed a new monoclonal antibody therapy.

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The FDA has authorized a human clinical trial of the CSX-1004 injection that provides no high and prevents any type of overdose.

The antibody attacks the fentanyl in the bloodstream before it has the chance to reach the brain.

"Whether it's injected intravenously, or snorted through the nose or even taken orally, once it gets to the bloodstream, this antibody is going to grab it with high-affinity and prevent it from inducing it's harmful effects in the brain," Cessation Therapeutics chief scientific officer Andy Barrett said.

Unlike Narcan that's given by someone else after an overdose, the antibody would be given by a doctor before someone uses fentanyl. It has shown 30 days of overdose prevention in non-human testing.

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The hope is that this would be another tool in the fight against fentanyl deaths.

"We're trying to get to high-risk individuals before they experience an overdose and provide a protective mechanism in the form of this antibody so fentanyl is rendered ineffective," Barrett said.

"Our goal is to keep these people alive so that they can go and get other treatments," Woody said.

The Santa Clara County Fentanyl Working Group's Dr. Rachel Sussman says there are other pre-overdose treatments for opioids, like vivitrol, and more study needs to be done before CSX-1004 goes receives full FDA approval.

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But, she says this could be helpful.

"We do have several tools already and I think one of our challenges is making sure that those existing tools are not underused," Sussman said. "But, another tool would never hurt. And, absolutely I think that the more things we have to offer patients the better."

This treatment is in the early stages of the approval process.

While the first round of human testing begins Tuesday, FDA approval would not come until late 2025 or early 2026.

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