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PsyBio Therapeutics is developing psychoactive compounds which could be a mental health game changer

Last updated: 08:21 07 Dec 2021 EST, First published: 14:00 25 Nov 2021 EST

Snapshot

  • PsyBio Therapeutics successfully completes first pre-IND meeting with the FDA
  • PsyBio Therapeutics begins European manufacturing of its proprietary biosynthetic compounds
PsyBio Therapeutics Corp -- is developing psychoactive compounds which could be a mental health game changer

About the company

PsyBio Therapeutics is a biotechnology company developing novel formulations of psychoactive molecules using genetically modified bacteria for the treatment of mental health and other disorders. The team has broad experience in drug discovery utilizing synthetic biology and extensive clinical and regulatory experience moving drugs through human studies and regulatory protocols. Research and development are currently ongoing for natural occurring tryptamines including psilocybin in different varieties of magic mushrooms, dimethyltryptamine and its derivatives, and mescaline and combinations thereof. The company is also researching and developing new molecule structures that do not occur in nature which may have unique therapeutics properties.

How it is doing

07 Dec 2021

PsyBio Therapeutics Corp has announced the successful completion of its initial pre-Investigational New Drug (IND) application meeting with the US Food and Drug Administration (FDA) as part of the regulatory submission process. 

The company said the focus of the pre-IND meeting was to discuss potential indications, manufacturing strategy, and obtain regulatory guidance as it guides its technology forward towards regulatory approval. 

The responses received from the FDA to these initial set of questions were constructive and no changes were proposed over its approach, PsyBio said. Based upon this initial discussion, the company said it intends to submit compound-specific pre-IND meeting requests to define manufacturing and clinical trial parameters, it added. 

"PsyBio was created to develop novel therapeutic candidates with the goal to help improve human health," the company’s chief medical officer Dr Michael Spigarelli said in a statement.

30 Nov 2021

PsyBio Therapeutics Corp., a biotechnology company developing a portfolio of psychoactive compounds aimed at the treatment of mental health disorders, told shareholders that it has filed “six additional provisional manufacturing patent applications” to expand its intellectual property portfolio. 

The Oxford, Ohio-based biotech said it had filed the applications with the United States Patent and Trademark Office (USPTO) and they cover a “broad range of approaches to PsyBio's biologic methodology.” 

19 Nov 2021

PsyBio Therapeutics announced that it has filed six additional provisional manufacturing patent applications to expand its intellectual property portfolio. 

The Oxford, Ohio-based biotech company said that the new manufacturing patents cover a broad range of approaches to its biologic methodology as it pertains to the current landscape of biotechnology.

What management says

01 Jul 2021

PsyBio Therapeutics Corp (TSXV:PSYB) (OTCMKTS:PSYBF) CEO Evan Levine tells Proactive ​it is starting to manufacture proprietary biosynthetic psychedelic compounds in Europe. Tevine says the initial pilot-scale batch manufacturing run is the Florida-based company’s first in the continent, and is working with France’s Biose Industrie, which commercializes pharmaceutical products based on live bacterial production. 

PsyBio Therapeutics begins European manufacturing of its proprietary...

PsyBio Therapeutics Corp (TSXV:PSYB) (OTCMKTS:PSYBF) CEO Evan Levine tells Proactive ​it is starting to manufacture proprietary biosynthetic psychedelic compounds in Europe. Tevine says the initial pilot-scale batch manufacturing run is the Florida-based company’s first in the continent, and is...

on 1/7/21