Working on building out a platform of psychedelic analogs to treat neuropsychiatric and neurodegenerative disorders
CEO: Mark Rus
Based: Cambridge, Massachusetts
Clinical focus: Delix is currently running its two lead programs through investigational new drug-enabling studies to bring them into the clinic next year. It plans to test them in undisclosed neuropsychiatric indications.
The scoop: Psychedelics have taken the biopharma world by storm since the approval of Spravato. There's been an onslaught of investment, startup launches and hopes for new mental health treatments. Delix is attempting to create a class of drugs that aren’t hallucinogenic and don’t lead to addictions. It wants them to be scalable enough, via an orally available formulation, to address the expanding mental health crisis, which has been worsened by the COVID-19 pandemic.
What makes Delix fierce: Delix doesn’t see itself as a one or two asset company that is attempting to simply treat some patients. Rather, the biotech is focusing on psychoplastogens, a class of drugs that enhance connections between brain cells, and building a library of nearly 1,000 compounds that might play a role in treating mental illnesses.
Psychedelics have made headway in depression, post-traumatic stress disorder (PTSD) and other mental disorders, but they have limitations when it comes to their hallucinogenic effects, addictive properties and barriers to scalability. Investors and Big Pharma have pumped a boatload of money into the space, through investments in Atai Life Sciences, MindMed, Compass Pathways, Beckley Psytech and others. The approval of the anesthetic ketamine drug Spravato in March 2019 opened the floodgates.
Delix was born in 2019 out of the lab of David Olson, Ph.D., co-founder and chief innovation officer at Delix, at the University of California, Davis. Olson and his group wanted to see if psychedelics work could help with cortical atrophy through the promotion of neuroplasticity in the prefrontal cortex.
In depression, PTSD, substance use disorder and others, the branches of a tree get trimmed and the leaves fall off, Olson said, analogizing neurons to trees. Dendrites are the branches and leaves that symbolize synapses. Once that happens, “the prefrontal cortex cannot communicate with other brain regions that control motivation, fear, cognition, and that’s why you have these overlapping, highly comorbid disorders,” he said.
Olson and his lab have found that “psychedelics can do what ketamine does to cortical neurons and regrow them and that they are incredibly potent at doing this,” he said, referring to a 2018 publication in Cell Reports.
Delix hopes to make safer alternatives to psychedelics that produce long-lasting changes after just one administration, Olson said.
Antidepressants and other attempts by various Big Pharmas and neuropsychiatric startups have “helped a ton of people,” but there “haven’t been that many innovations” in the field, says Mark Rus, CEO of the 20-employee startup. Rus knows a thing or two about the space: He was previously head of Shire Pharmaceuticals’ neuroscience franchise and has been an adviser to multiple Atlas Venture startups since then.
Delix is approaching neuropsychiatric and neurodegenerative treatments from a healing angle, Rus said. “That is why I couldn’t run fast enough to this opportunity,” the CEO said.
With publications in Nature, Molecular Psychiatry and Cell this year, Delix is roaring ahead with studies it hopes will garner a green light from the FDA for clinical trials next year. Preclinically, Delix’s compounds have been shown to compare against psilocybin, ketamine, fluoxetine and others, Rus said.
With the phase 1 studies slated to have data readouts next year and into 2023, Delix’s first potential FDA approval is likely years away, but the biotech sees its regulatory pathway more akin to classic central nervous system drugs than the burgeoning psychedelic field, Rus said. Delix’s candidates don’t have hallucinatory risks and, as orally bioavailable small molecule take-home drugs, Delix’s products don’t have to be administered in an in-patient setting, which brings logistical and financial hurdles.
If those first two clinical studies go well, they will lay the groundwork for neurodegenerative disorders, Rus said. Indications for schizophrenia and frontotemporal dementia are also in the cards, the CEO added.
Olson sees a potential platform play similar to Moderna's. The small biotech emerged as one of the leading biopharmas in the world during the pandemic with its mRNA platform technology being used to vaccinate tens of millions of people against SARS-CoV-2. The platform is being tested for other viruses such as HIV.
Delix doesn’t view its drug hopefuls in isolation. The pandemic has catapulted a bevy of at-home, virtual therapy providers and digital therapeutics to the forefront of mental health treatment.
“If that’s matched with the ability to at-scale bring an innovative healing-based treatment into the home, we think those two intersecting trends down the road could really be like one-plus-one equals 10,” Rus said.
One by one, Delix is building out its team. Olson, who co-founded the biotech as chief scientific officer is now chief innovation officer. Kurt Rasmussen, Ph.D., stepped into the CSO role this summer after leading the National Institute on Drug Abuse’s division of therapeutics and medical consequences since 2018. Before that, Rasmussen spent more than 25 years at Eli Lilly, including as head of neuroscience research where his lab work included drugs such as Prozac, Zyprexa and Symbyax.
Delix is also led by Chief Medical Officer Brigitte Robertson, M.D., who joined in August after serving in the same post at Yumanity Therapeutics.
Investors: OMX Ventures, ARTIS Ventures, Presight Capital, Risk and Return, Apeiron Investment Group and Noetic Fund.
Delix's Fierce15 profile was originally featured on FierceBiotech here: https://www.fiercebiotech.com/special-report/delix-therapeutics-fierce-biotech-s-2021-fierce-15
Find the full list of winners here: https://www.fiercebiotech.com/special-report/fierce-biotech-s-2021-fierce-15-0