Welcome to the News You Might Have Missed, a weekly roundup of news items to help you catch up and stay informed.
It was a busy week with lots of news, have a look and see you next week for another update.
Entheon Biomedical Announces the Approval of DMT Clinical Trial
The company announced the approval by the local Dutch ethics committee of EBRX-101, a comprehensive phase I clinical trial evaluating the pharmacokinetics, pharmacodynamics and safety profile of N,N-dimethyltryptamine (DMT). The study will be conducted at the Centre for Human Drug Research, in Leiden, Netherlands, with patient screening scheduled to begin this month.
Psyched Wellness Announces Additional Positive Results from the 14-day Oral Toxicity Study of AME-1
The 14-day oral invivo study resulted in a dose-dependent increase in Toll-like-receptor-2 expression, while Dectin-1 did not have any change in cell surface expression under the same study conditions. The marginal increase of up to two-fold in the TLR-2 study suggests AME-1 could be a potential bioactive agent with possible immune-priming effects, which may be due to its ability to increase cell surface plasma membrane concentration content of TLR-2.
PharmaDrug Announces Filing of US Provisional Patent for Cepharanthine to Treat Prostate Cancer
Patent claims on synergistic application of cepharanthine, cabazitaxel and other taxane family members used in combination to treat primary, metastatic and chemotherapy-resistant prostate cancer.
Mydecine Submits Pre-Investigational New Drug Briefing Package to the FDA for MYCO-001 Seamless Phase 2/3 Smoking Cessation Clinical Trial
The study will be led by Principal Investigator Dr. Matthew Johnson, Ph.D., Professor of Psychiatry and Behavioral Sciences at Johns Hopkins University. The university is the flagship site of the planned placebo-controlled study, which will assess the safety and efficacy of psilocybin-assisted psychotherapy utilizing MYCO-001 to treat tobacco addiction.
“We are excited to move forward on this important study, and our team has been working diligently to ensure that our pre-IND package is complete,” said Mydecine CEO Josh Bartch.
PharmaTher Granted FDA Orphan Drug Status for Ketamine
The ODD for ketamine to treat SE expands the Company’s current FDA ODD portfolio for ketamine to treat amyotrophic lateral sclerosis and complex regional pain syndrome and strengthens the Company’s strategy in developing novel uses and delivery methods (i.e. microneedle patch) for ketamine to treat rare disorders and life-threatening conditions.
FILAMENT HEALTH AND CYBIN THERAPEUTICS ANNOUNCE APPROVAL FOR PHASE II CLINICAL TRIAL FOR DEPRESSION
Trial to investigate the effects of Filament’s botanical psilocybin drug candidate and Cybin Therapeutics’ protocols in treating major depressive disorder in patients taking SSRIs.
Small Pharma Reports Fiscal Third Quarter 2021 Highlights
Significant progress made across the clinical portfolio with lead candidate advancing through trials. Click here for details.
