Trade To Black Podcast: Cybin Filing Investigational New Drug Application This Quarter
It’s been a long journey, but Cybin Inc. (NEO: CYBN) (OTCMKTS: CLXPF) is making strides towards filing its first Investigational New Drug (IND) application with the FDA. Leading up to this milestone event, TDR Founder Shadd Dales caught up with CEO Doug Drysdale this past week at the Benzinga Cannabis Capital Conference in Miami. The topics of conversation the company’s clinical trial roadmap, the booming need for improved anxiety therapeutics, the state of psychedelic markets and more.
Cybin’s leading drug investigational compound, CYB004, is a proprietary DMT compound. In preclinical studies, CYB004 has demonstrated potential efficacy at lower doses while also increasing the duration of drug effect—while possibly alleviating common negative experiences associated with classical DMT. The company will pursue social anxiety disorder and generalized anxiety disorder as the initial target indications for CYB004.
And according to Doug Drysdale, CYB004 could be getting into the clinic in the not-too-distant future. Cybin will soon be filing its first IND with the FDA to obtain permission to begin human clinical trials. Once received, it will mark an important milestone in the company’s short history:
We had a really busy start to the year, and now is crunch time. We are this quarter planning to file our first IND. So everything we’ve been doing for the last eighteen months it’s kind of coming together. Right now, all those pieces of information, all the studies, all the test results all have to go into this massive document that’s digital. But it wasn’t it would be a truckload of paper... This is eighteen months of work.
If Cybin Inc. is successful on this front, it expects to initiate the pilot study in the third quarter of calendar year 2022.
Click the embedded link to view more of our latest interview with Cybin Inc. CEO, Doug DrysdaleIt
To view our previous Trade To Black Podcast, click here.