Shantel
Key Takeaways:
- Successful Completion of 1st Cohort Dosing in DLX-001 Phase I Trial
- Dose Escalation Approval for Second Cohort
- Positive Results: No Adverse Events or Psychotomimetic Effects
- Alignment of Predicted Pharmacokinetics with Observed Parameters
- Confirmation of Viability of Oral Administration
- Significance of Milestone for Delix Therapeutics and Neuroplasticity Field
- Enrollment and Objectives of the Phase I Trial
- Collaborations and Recognition of Delix Therapeutics
- Contact Information for Investor Relations and Media Relations
Successful Completion of 1st Cohort Dosing in DLX-001 Phase I Trial
Delix Therapeutics, a clinical-stage neuroscience company, announces the successful completion of dosing the first cohort of subjects in its phase I clinical trial for DLX-001. DLX-001 is a non-hallucinogenic psychoplastogen, a novel compound developed by Delix Therapeutics.
Dose Escalation Approval for Second Cohort
The positive outcomes of the first cohort, which showed no clinically relevant adverse events or psychotomimetic effects, have led to the approval of dose escalation for the second cohort. The Dose Escalation Committee’s confidence in proceeding with an increased dose demonstrates the potential of DLX-001 as a safe and promising therapeutic option.
Positive Results: No Adverse Events or Psychotomimetic Effects
During the first cohort of the phase I trial, no clinically relevant adverse events or psychotomimetic effects were observed in the subjects. This outcome provides further evidence of the compound’s safety profile and supports its potential as a non-hallucinogenic treatment option.
Alignment of Predicted Pharmacokinetics with Observed Parameters
The trial results also showcased a close alignment between the predicted pharmacokinetic parameters and the observed parameters in the human subjects. This alignment strengthens the confidence in the preclinical findings, particularly regarding the timing of drug activity and clearance.
Confirmation of Viability of Oral Administration
The first cohort confirmed the viability of oral administration of DLX-001. The subjects demonstrated bioavailability and oral pharmacokinetic characteristics, further supporting the compound’s potential as an accessible and practical treatment option.
Significance of Milestone for Delix Therapeutics and Neuroplasticity Field
Mark Rus, CEO of Delix Therapeutics, emphasizes the milestone’s significance for both DLX-001 and the entire Delix platform. The achievement reflects the company’s progress towards becoming a leading neuroplasticity company. Delix Therapeutics is excited about the potential of DLX-001 and its other non-hallucinogenic compounds to shape the field of neuroplasticity in the months and years ahead.
Enrollment and Objectives of the Phase I Trial
The phase I clinical trial aims to enroll approximately 100 healthy volunteers and has multiple objectives, including assessing safety, pharmacokinetics, psychotomimetic activity, and markers of brain activity and synaptic plasticity. The trial is currently being conducted at the Center for Human Drug Research (CHDR) in the Netherlands, a renowned institute specializing in early-stage clinical drug research. Full phase I data and readout for the trial are expected in early 2024. Delix Therapeutics is also preparing an Investigational New Drug (IND) application to initiate trials in the United States.
Collaborations and Recognition of Delix Therapeutics
Delix Therapeutics continues to expand its network of collaborations and partnerships. The company recently formed a professional relationship with a legal firm specializing in Intellectual Property (IP), enhancing its capabilities in providing comprehensive IP solutions to its clients. Delix Therapeutics has gained recognition in the scientific community and has been featured in prestigious publications such as Nature, Cell, and Science. The company has also received awards and accolades, including being listed on Fierce Biotech’s Fierce 15 list and Nature’s Top Startups to Watch. Delix Therapeutics collaborates with esteemed institutions such as the Institute for Psychedelics and Neurotherapeutics at the University of California Davis and the National Institute on Drug Abuse (NIDA).
