Data from Lobe Sciences has demonstrated that combination therapy of psilocybin and N-Acetylcysteine is more effective than monotherapy for mTBI and PTSD.
Lobe Sciences has announced interim data from its preclinical research studies showing the effectiveness of its combination therapeutic candidates, demonstrating that psilocybin and N-Acetylcysteine is statistically significantly better than either agent alone or a placebo for mild traumatic brain injury/concussion (mTBI) and post-traumatic stress disorder (PTSD).
The research, being conducted in collaboration with the University of Miami Miller School of Medicine under the leadership of Michael Hoffer, M.D., professor of otolaryngology and neurological surgery, was carried out in established rodent models of mild traumatic brain injury/concussion PTSD.
CEO of Lobe, Philip Young, commented: “I am thankful to Dr Hoffer and his team for their excellent work. This data is validation of our therapeutic hypothesis that the use of these two active therapeutics provides superior efficacy to either placebo or single-drug therapy in this model of TBI and PTSD. We believe that these data directly support our IP and will allow us to build on our leadership position in the rapidly evolving psychedelic therapeutics marketplace.
“Despite the significant shortage of psilocybin in North America the Miami team was able to deliver these data. However, the shortage has impacted the timing of the next planned studies. We have responded to this supply shortage by working to identify a manufacturing company who will supply high purity cGMP psilocybin to the University of Miami so that the remaining studies can be completed.”
Dr Hoffer added: “These are promising results that suggest that a combination of psilocybin and NAC can work better than either drug administered as a single agent after traumatic brain injury. We look forward to future work that will help to reaffirm these outcomes and further clarify the role of medical countermeasures in combatting traumatic insults to the brain.”
“We are extremely pleased that the interim data from our preclinical studies validates our therapeutic hypothesis that NAC plus psilocybin would provide superior efficacy over either agent used alone. NAC remains the only compound that has successfully completed a human phase 1 equivalent trial in a population of individuals who had acute mTBI.
“Dr Hoffer’s team has made significant in-roads studying psychedelic medicine and NAC specifically as it relates to mTBI and PTSD. Given there are currently no approved medicinal treatments for mTBI and PTSD, we feel this data is supportive of our plans to advance into future human clinical trials which we hope will eventually lead to approved therapeutics for these unmet needs,” commented Maghsoud Dariani, CSO of Lobe.
