Lobe Sciences Ltd (CSE:LOBE, OTCQB:LOBED) said its exclusive discovery and manufacturing partner Quality Chemical Laboratories LLC (QLC) has initiated commercial formulation activities for the company’s new chemical entity L-130.
In a statement, Lobe said the QLC has developed a synthetic pathway for psilocybin, psilocin and psilocin analogues exclusively for Lobe, and has agreed to supply Lobe with research and commercial quantities of its two new chemical entities L-130 and L-131 under an exclusive arrangement.
In collaboration with contract research organization Clearway Global LLC, QLC will prepare the chemical, manufacturing and control section of the investigational new drug application being filed (for L-130) later this year, Lobe added.
READ: Lobe Sciences inks clinical research agreement with Integrative Headache Medicine of New York to study L-130 as chronic cluster headache treatment
Further, material produced at QCL will also be used in the company’s recently announced Phase 1/2a study to evaluate L-130 as a treatment for chronic cluster headaches, a debilitating orphan disease.
Lobe CEO Philip Young said the company’s collaboration with QCL has provided Lobe access to industry-leading, patent-pending psilocin compounds.
“QCL's ability to rapidly discover, validate and manufacture multiple stable psilocin compounds has put Lobe in a leadership position in the development of psychedelic-derived therapies,” Young said.
“This work has allowed Lobe to have cGMP products available for our first Phase 1 safety study as well as the previously announced cluster headache study."
QLC CEO Dr Yousry Sayed added that QLC’s research scientists have delivered several new stable chemical entities allowing them to use other psilocin salts instead of psilocybin as a therapeutic.
“Our work on low-dose and novel psilocin compounds has the promise to significantly improve the lives and mental health of people around the world,” he said.
“By using these novel salts instead of psilocybin, we hope to improve bioavailability and allow lower doses to be used to treat neurological disorders."
Lobe is a biopharmaceutical company focused on developing patient-friendly, practical psychedelic medicines. The company, through collaborations with industry-leading partners, is engaged in drug research and development using sub-hallucinatory doses of psychedelic compounds and the development of innovative devices and delivery mechanisms to improve mental health and wellness.
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