Lobe Sciences Hopes To Move Novel Psilocin Drug Compounds Quickly Through The FDA Funnel

In this new Trade To Black Podcast, TDR Founder Shadd Dales interviews the CEO of Lobe Sciences LOBEF, Philip Young. Lobe Sciences is an emerging psychedelic biotech company developing psilocin and nontraditional medicines for better brain health.

While psilocybin gets all the attention in the psychedelics industry, psilocybin is actually not bioactive on its own and must be converted into psilocin through a process called dephosphorylation to take effect. Psilocin is psychoactive but not stable, as it degrades quickly in the presence of air, heat, and light. The issue of molecule stability is why most psychedelic companies continue to work with psilocybin, despite its increased cost.

Enter Lobe Sciences, which after at least ten months of research development, appears to have solved the issue of stability of the psilocin molecule. As Philip Young explains, the company has synthesized at least nine psilocin compounds for which it is hoping to take to clinical trial shortly:

"Psilocin is the active moiety in psilocybin. Nature made psilocybin basically as a prodrug, so, in order to stabilize psilocin, nature added an additional molecular structure to it so that it would not degrade rapidly. My scientists when we were manufacturing psilocybin, informed me that it was a lot less expensive just to make psilocin. Sixty percent of our costs came in after we synthesized psilocin to make the prodrug psilocybin. Historically, people couldn’t make a stable psilocin—after ten months of work we filed patents on nine separate psilocin compounds, all stable. And we’re taking the two best looking ones forward. We call those L-130 and L-131."

Specifically, Lobe Sciences hopes to access 505(b)(2) new drug application (NDA) pathways with the U.S. Food and Drug Administration to expedite clinical studies. The provisions of 505(b)(2) were created, in part, to help avoid unnecessary duplication of studies already performed on a previously approved drug; the section gives the FDA express permission to rely on data not developed by the NDA applicant.

A 505(b)(2) NDA contains full safety and effectiveness reports but allows at least some of the information required for NDA approval, such as safety and efficacy information on the active ingredient, to come from studies not conducted by or for the applicant. This can result in a much less expensive and much faster route to approval, compared with a traditional development path.

This article was originally published on The Dales Report and appears here with permission.