Cybin Inc's Two Deuterated Psychedelic Molecules Achieve Positive Topline Clinical Results

Clinical-stage biopharma company Cybin Inc. CYBN announced positive safety and efficacy data from its Phase 1 studies of CYB004 (intravenous administration) and SPL028 (intravenous and intramuscular administration) in healthy volunteers. 

Both compounds are novel deuterated DMT molecules within the company’s next-gen psychedelics program targeting Generalized Anxiety Disorder (GAD.) DMT is a hallucinogenic tryptamine drug that naturally occurs in several plant species and animals, including humans. 

See Also: Cybin Officially Owns Small Pharma: Plans For New 'International Leader' In Psychedelic Therapeutics

Results showed:

• CYB004 produced “robust” psychedelic effects. Although the general rule of the stronger the dose, the more intense the experience, Cybin’s deuterated DMT reportedly provided a stronger experience even at lower doses as compared to DMT. 

• These psychedelic effects had a fast onset administered as an IV over 5 minutes and continued for some 40 minutes after, without needing an extended infusion.

• CYB004 was well-tolerated with no serious adverse events, most of them being mild to moderate and self-limiting.

• SPL028, administered both intravenously and intramuscularly, was safe and well-tolerated. Researchers found a specific dose for the IM that produced a “breakthrough psychedelic experience,” which lasted between 55 to 120 minutes for most people -usually on the shorter side.

Why It Matters

The new results showed two drug profiles enabling potential data cross-over between them. Both compounds showed concentrations in the “effective” range, and both IV and IM routes were found safe and well-tolerated by participants. 

IM dosing produced strong psychedelic effects with a short duration, a finding pointing at a potentially “highly scalable” effective and “more convenient” dosing method as compared to IV infusion.

Cybin’s CEO Doug Drysdale highlighted that these are “the first-in-human studies of deuterated DMT in healthy participants,” and that the IM dosing results are “highly promising” and will help inform dosing in future clinical trials. Plus, he says they will save Cybin time and resources as they eliminate the need for further formulation studies of other methods, i.e. subcutaneous dosing.

The team believes the studies’ “robust” dataset on safety and tolerability will propel an upcoming, bigger Phase 2 study on patients with Generalized Anxiety Disorder in Q1 2024. 

• Photo: Benzinga edit with photo by aiyoshi597, Bacsica, Gisele Yashar and Gorodenkoff on Shutterstock.