Intramuscular dosing showed the potential to provide a more convenient dosing method for patients when compared to IV infusion.
Cybin on Jan. 8 announced positive safety, pharmacokinetic (PK) and pharmacodynamic (PD) data from its Phase 1 studies of CYB004 (IV) and SPL028 (IV and IM) in healthy volunteers.
CYB004 and SPL028 are proprietary deuterated DMT molecules within the company’s DMT program in development for the treatment of generalized anxiety disorder.
“Results from the Phase 1 studies in the CYB004 and SPL028 programs demonstrated PK and PD profiles with the potential to bridge data across these molecules, and the PK profiles for both molecules demonstrated concentrations in the effective range,” Cybin explained in a news release.
Both intravenous (CYB004 and SPL028) and intramuscular (SPL028) administration routes were safe and well-tolerated, according to the company. Intramuscular dosing showed the potential to provide a more convenient dosing method for patients when compared to IV infusion.
IM-Dosing Results ‘Highly Promising’
Intramuscular dosing of SPL028 produced “robust psychedelic effects lasting a short duration in the majority of subjects, a finding that supports IM administration as a well-tolerated and effective dosing method that is highly scalable,” according to Cybin.
The study identified an IM dose of SPL028 that resulted in “a breakthrough psychedelic experience,” with a total duration ranging from 55 to 120 minutes.
“The positive data from our Phase 1 studies of CYB004 and SPL028 are highly encouraging with the combined data from these studies enabling us to prioritize our 2024 development plan for our deuterated DMT program,” Cybin CEO Doug Drysdale said. “Importantly, these are the first-in-human studies of deuterated DMT in healthy participants. We are pleased that both the IV and IM administrations produced robust psychedelic effects and were safe and well-tolerated.”
Drysdale called the results for intramuscular dosing “highly promising,” adding that they’ll “help inform dosing in future clinical trials, saving time and resources by eliminating the need for further formulation studies of other methods such as subcutaneous dosing.”
In the Phase 1 CYB004 study, escalating doses of DMT IV infusion over 90 minutes were well-tolerated, according to Cybin.
The “robust psychedelic effects” that CYB004 produced were rapid in onset when administered as an IV bolus over five minutes and persisted for about 40 minutes after the bolus without the need for an extended infusion, according to the company.
“This short duration of effects has the potential for CYB004 to be a scalable treatment that can be delivered in a shorter period of time compared with longer-acting psychedelics,” Cybin asserted in a news release.