Neurala is Rewiring Mental Health with Psychedelic Biotech

When Dr Daniel Perkins, long-time researcher and head of the psychedelics research and therapeutics unit at the University of Melbourne, visited South America around 2014, his life – and direction of research – changed.

“My first PhD was looking at programs to support long-term unemployed people facing complex mental health and other barriers, such as addiction and homelessness” Perkins says.

“Along the way it became apparent how difficult it was to actually bring about meaningful, transformative change to these people.”

But in South America, he met people who after using the traditional plant medicine ayahuasca, reported “incredible benefits after decades of lukewarm effects from antidepressant use.”

While initially quite skeptical, Perkins decided to investigate whether their claims were true, launching the world’s largest study investigating the therapeutic profile and safety of ayahuasca. Soon the research began to reveal something profound.

“As our research progressed, it really looked like there was potential for genuine, transformative change in people’s lives, not just symptoms management” he says.

Founding Neurala 

Today, along with Dr Jerome Sarris, Perkins is a co-founder of Neurala Biosciences, a Melbourne biotech startup poised to address complex conditions like addictive and depressive disorders by developing a range of innovative drugs as registered medicines.

The company has already undertaken multiple FDA consultation meetings to ensure their program is clinically viable and aligned with regulatory requirements.

These build on natural compounds which are further refined with cutting-edge pharmaceutical science, developing differentiated medicines spanning high-dose psychedelic to sub-perceptual effects.

Science Meets Vision

Where CEO Perkins brings tenacity and world-leading DMT-harmala research expertise, CSO Sarris complements this with a somewhat mercurial perspective and decades of psychiatric clinical trial research, creating a vibrant balance between the co-founders. As Jerome says, “we have our feet grounded in rigorous science, and heads in the sky embracing an expansive therapeutic vision.”

The pair are focusing on substances like DMT and harmala alkaloids, which are known to influence brain pathways related to mood, emotion and neuroplasticity (the brain’s ability to rewire itself). Neurala Biosciences’ current clinical focus on addictive disorders and depression is also no accident.

“The pilot data that we’ve been generating over the last 10 years, showed those therapeutic areas as having particularly strong outcomes compared to a range of other conditions,” Daniel explains.

The potential for DMT and harmala alkaloids for example to treat depression is particularly striking.

“These compounds appear to act very quickly, with effects that are sustained,” Daniel says, referencing a Brazilian study that observed “very substantial” improvements within 24 hours for patients who had endured an average of nine years of treatment-resistant depression.

For substance use disorders, the compounds appear to address “negative mood aspects,” alongside “reductions in craving, while boosting self-efficacy and improving lifestyle behaviours and the desire to lead healthy lifestyles in general.”

Early Traction

The company has already achieved significant milestones. A major highlight was the completion of their proof-of-concept study at St. Vincent’s Hospital last year.

“When we looked at the data the acute effects were very robust, and highly correlated with persisting psychological benefit. In fact, effects were stronger than most other studies published with similar compounds,” Daniel says.

Neurala’s innovative work has since garnered significant support, including federal funding through CSIRO Kickstart and several government grants. “We’ve also received funding through the AEA Ignite program for around $500,000, and via LaunchVic’s MedTech Market Growth Program a $50,000 grant,” Jerome says.

Investment totaling $4.5m from Tin Alley Ventures and the University of Melbourne Genesis Pre-Seed Fund further validated their research. “It really felt like a very powerful external validation of all the work that we’ve been putting in to get the company established,” Jerome says.

Next Steps: Clinical Trials and Global Growth

Looking ahead, Neurala’s clinical pipeline is advancing rapidly. “We have just submitted our Phase 1 Study for ethics approval, and we’ll be looking at getting that underway in Q4 of this year,” he says.

“This will be followed up by our next human clinical study assessing our second lead asset, currently in development, a shorter-acting intranasal DMT harmala combination.”

The team are also strengthening the company’s US and EU connections via the appointment of a Senior Board Chair, and are presently undertaking a $2.6m seed extension prior to a planned Series A raise in 2027.