A Tampa biotech startup studying whether magic mushrooms could treat illnesses has received $2.5 million from investors led by a Florida venture capital firm.
Psilera Bioscience researches whether there are healing properties in psychedelics, which trigger hallucinations and intensified feelings. Some scientists believe its ingredients — DMT, psilocybin and psilocin — may alleviate conditions that plague millions of Americans.
Think mental illness, addiction and even Alzheimer’s disease.
“Current treatments for those illnesses aren’t very effective,” co-founder and CEO Chris Witowski said. “Psychedelics haven’t been explored as an option since the 1970s. We now have the tools to see how the drugs function in the brain, and analyze if they’re actually working.”
The unconventional research caught the eye of Iter Investments, an 11-month-old Fort Lauderdale venture capital firm.
Managing partner Dustin Robinson said its portfolio boasts seven psychedelics-focused companies. Most operate outside U.S. borders, but Psilera is uniquely near home.
“I see them as a leading company in the psychedelics ecosystem, right in our neighborhood,” Robinson said. “It was an amazing opportunity to operate within Florida.”
Baird Inc., JLS Fund, Receptor, What If Ventures, and Psilera founders and board members also contributed to the investment.
They are placing a bet on Psilera’s “research and development” efforts, Witowski said.
That includes creating analogs, slightly-altered psychoactive compounds the startup formulates to see if they can treat nervous system disorders.
Since its inception in 2019, Psilera has also worked with computational chemistry — a mixture of computer models and functional MRIs — to simulate how those compounds prompt molecular changes.
Its focus has now shifted to developing delivery systems for getting the psychoactive compounds into patients, with five full-time employees and a gaggle of interns dedicated to the task.
The team is in the midst of formulating a nasal gel that would eliminate the use of needles, which have a negative association with drug abuse. It’s probably wise, Witowski said, to remove sharp objects during treatment.
“Who wants a needle in their arm when they’re hallucinating?” he said.
Transdermal patches also show promise.
Drugs would flow through the skin and to the brain gradually in low doses. The slow process could subdue the psychedelic effects, allowing patients to shorten or forgo experiencing a “trip,” or an hours-long sensory episode.
Good trips elicit euphoria and a sense of connection to others. But bad trips can cause mental confusion, anxiety and psychotic episodes that cause people to see bizarre images or experience severe paranoia.
The patch will be tested on 10-20 healthy people early next year in a Phase 1B trial, in order to gauge its safety and side effects.
When administered medically, psychedelics can alter how people think and potentially dissipate effects from neurological disorders.
How? “We can’t pinpoint it exactly,” Witowski said.
But the theory is based upon erasing and re-paving connections between nerve cells, called neural pathways.
The pathways in a patient with a neurological disorder reinforce one pattern of thought. A depressed person, for example, cycles through the same negative ideas about their life. Perhaps they suffer from prolonged loneliness or work stress. Those feelings dwell inside them, day after day.
“It’s like if you’re out on a sled,” Witowksi said. “You slide down one day and then follow that same path because it’s already laid. It’s just easier because you don’t have to go through fresh snow.”
Drugs, like DMT or dimethyltryptamine, may simulate a storm. The substance brings on hallucinations and out-of-body experiences.
“Psychedelics lay down a fresh layer of snow,” he said. “Now you don’t have the same trodden path. It disrupts that introspective voice you have, and this creates an opportunity for clinicians.”
Psilera researchers believe that, combined with talk therapy, positive and forward-thinking thought patterns can then blossom. This change could potentially relieve triggers and trauma.
It’s too early to say which disorder will respond best to psychedelic therapy and to what specific substances, Witowski said.
Other companies are implementing psychedelics to treat traumatic brain injury or to improve emotional well-being. Multiple clinical trials exploring therapeutic uses of psilocybin are underway with approval from the Food and Drug Administration.
And Witowski said a Phase 3 clinical trial into MDMA, commonly known as ecstasy, revealed its possible effect on Post-Traumatic Stress Disorder patients. It could aid those with common PTSD symptoms such as nightmares or unwanted memories of the trauma, the May 2021 study found.
The federal government labels psychedelics as Schedule 1 drugs, meaning they may not be prescribed or used clinically. Like heroin, peyote and LSD, the drugs have a high potential for abuse and no approved medical application, the government says.
Those restrictions have limited research into the substances.
A stain also fell over psychedelics in the 1970s, when recreational use overshadowed its medicinal potential. Thanks to strides in cannabis research and legalization at the state level, “the stigma has been lifted,” Witowski said.
The Drug Enforcement Administration has granted a handful of universities permission to research psychedelics.
The University of South Florida is one of them, and Psilera is an early beneficiary.
The company operates as a member of USF Connect’s incubator program, which permits nearly 70 startups to take advantage of its research equipment, students and faculty. Its co-founders — Witowski and Jackie von Salm — completed their doctoral degrees in natural products chemistry from USF.
The university earned DEA approval in February.
“That was a great development for the company,” said Michael Bloom, USF vice president for corporate partnerships and innovation. “But it was also great for the university and for the biotech sector in Tampa Bay.”
He said Psilera’s “work goes beyond a scientific challenge to truly addressing devastating diseases that touch nearly every family in some way.” That includes Witowski’s.
In the past two decades, his brother cycled through almost every available anti-depressant. His grandmother died after 15 years of battling Alzheimer’s.
The majority of Americans know someone who faces similar burdens. One in five people in the U.S. experience mental illness, according to the National Alliance on Mental Illness. The number of substance abuse and Alzheimer’s patients is in the millions.
To Witowski, the research offers a path to explore medicinal possibilities for ailments that have proven hard — and even impossible — to solve.
He partially thanks the pandemic for the recent progress.
“The COVID-19 pandemic almost caused a mental health pandemic concurrently,” he said. “In a lot of ways, that could be a catalyst for people to see these drugs more favorably, to see their potential.”
Correction: An earlier version of this story incorrectly stated the number of patients Psilera plans to include its in clinical trial.