Lobe Sciences Ltd (CSE:LOBE, OTCQB:LOBED) doesn’t just imagine a future where patients can access innovative psychedelics-based treatments for a range of mental and physical conditions from their homes – the Vancouver-based biotechnology company is working to make it a reality.
With an original aim of creating psychedelic-inspired medicines to treat central nervous system diseases, Lobe is now focused on developing and stabilizing psilocin — the active metabolite of psilocybin, a psychedelic compound found in more than 200 species of mushroom — for a range of indications including severe anxiety and a yet-to-be-announced rare disease.
READ: Lobe Sciences files patent for preparation of stable psilocin prodrugs and analogues
Lobe CEO Philip Young told Proactive what sets this company apart from other psychedelics businesses is its focus on how patients are treated, noting that having patients participating in psychedelic therapies confined to a clinic for six-to-10-hour sessions every few months is not a viable long-term pharmaceutical market.
“We’re doing the hard work nobody’s done and we’re going to identify the highest non-hallucinatory dose of our patent-pending compounds,” Young explained. “What we want to be able to do is treat patients where they live and work, and where their doctors are, to give them the opportunity to be treated with a pharmaceutical that doesn’t disrupt their lives.”
Lobe is working to put a dollar figure on the possible savings associated with at-home psychedelic treatments for patients and healthcare providers. “Keeping patients with their primary care physician has got to be less expensive and more amenable for both the patients and the treating physicians who would prefer to treat their patients over referring them elsewhere,” Young said.
Improving mental health treatments
Lobe’s goal is to develop safe and effective psychedelics-based therapeutics for a range of conditions that are not currently being treated optimally, including severe anxiety, post-traumatic stress disorder (PTSD), and traumatic brain injury (TBI).
According to Young, there has been little innovation in mental health treatments for decades. “There is new evidence the selective serotonin reuptake inhibitors (SSRIs), which have been the mainstay of treating depression and anxiety for 30 years, may not work,” he said. “They’ve got a long history of adverse events and for some depressed patients they increase the risk of suicide and suicidal ideation.”
“What we think we can do at Lobe is provide a therapeutic option that is non-addictive, that you can’t overdose on, and that provides an opportunity for patients to get off SSRIs or to never go on an SSRI. We believe we are even further insulated from adverse events because we’re not inducing hallucinatory activity which many patients do not want to experience.”
Clinical trial pipeline
Lobe is focused on the development of two patent-pending novel synthetic psilocin analogues L-130 and L-131. Noting that psilocybin is a Schedule I controlled substance in the US, Young explained that the company was developing its compounds in line with US Food and Drug Administration (FDA) standards to ensure compliance in other regulatory environments. “If you do it to FDA standards, then almost everybody else in the world accepts that,” he said.
The company has planned a Phase 1 study of L-130 to evaluate the safety of the drug in healthy volunteers, which is set to take place in late 2022 or early 2023. A second, multiple ascending dose study will evaluate the longer-term use of the drug and is set to be followed by a third and final safety study evaluating the pharmacokinetics and preliminary efficacy at the selected sub-hallucinogenic dose.
L-131 is expected to enter preclinical toxicity trials later this year or early next year, with Phase 1 trials anticipated to take place later in 2023.
“We plan to roll out all these studies over the next couple of quarters and look forward to bringing the data to those in the investment community,” Young said.
READ: Lobe Sciences updates investors on its regulatory and clinical development plans for its novel synthetic psilocin analogues L-130 and L-131
As part of its research, Lobe is investigating the synergistic effects of combining the dietary supplement N-acetylcysteine (NAC) with psychedelics to enhance their effects.
Young explained that this aspect of the company’s research stemmed from a study carried out at a field hospital in Iraq in 2012 and 2013 on soldiers with blast trauma where half of the participants were given NAC. “What they found was that NAC as a single agent given just after treatment for seven days had a statistical improvement in every measure of traumatic brain injury and head trauma,” he said.
“It was an unexpected finding and I’m surprised this didn’t have a bigger impact on the medical community as a whole because in general the outcome of TBIs is very poor and there is no FDA-approved pharmaceutical treatment.”
Young described this data as “compelling” and said it had given Lobe the confidence to move forward with its own human studies. He noted that the company takes protecting its intellectual property seriously, having filed multiple patents on combining psychedelics with NAC. More recently, the company filed additional patents for its novel psilocin compounds and a confidential Pediatric Orphan Drug indication.
Virtual reality and psychedelic treatments
In line with its goal to provide effective and accessible psychedelics-inspired therapies, Lobe holds a 50% stake with Los Angeles-based partner Virtual Psychedelics Inc in a company that is developing fully immersive virtual reality pods called the Krysalis System, which could be used to deliver counselling via virtual reality with or without psychedelic-assisted therapy.
The pod’s design includes biometric feedback and neural mapping to assist in psychedelic research, allowing both researchers and patients to see the effects of virtual or augmented reality. It is currently in the prototype stage, and Young said a working model is expected to be completed in late early 2023.
“The FDA has just started approving virtual content for counselling for depression and anxiety, and that trend is only going to grow given it was really pushed forward by the pandemic,” he said. “The pod will also be great for recreation, such as gamers and people who want to live in the metaverse.”
Contact the author at emily.jarvie@proactiveinvestors.com
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