Welcome to the News You Might Have Missed, a weekly roundup of psychedelic medicine news to help you catch up and stay informed.
Atai Partner IntelGenx Announces FDA Approval of Oral Film
Under-the-radar firm IntelGenx has just received FDA approval. The drug delivery company is focused on the development and manufacturing of pharmaceutical films (oral, fast-dissolving) films, with several products in development, some delivering psychedelic medicines.
While this approval is not for a psychedelic product (RIZAFILM is a film delivery migraine medication), this FDA green light is big news for a company that’s heavily committed to psychedelic development and partnerships.
Apex Labs Granted Approval for 160 Patient Macrodose Multi-Dose Psilocybin Clinical Trial by Health Canada
Apex Labs announces approval of SUMMIT-90. SUMMIT-90 is a double-blind, placebo controlled phase 2b study evaluating multiple doses of APEX-90 administered in-clinic with assisted psychotherapy for the treatment of severe depression within diagnosed PTSD. The 160 patient trial approval comes by way of a no objection letter received from Health Canada on April 14th, 2023 and the company aims to begin recruitment Q2 of 2023.
Sunstone Therapies Announces Positive Data on Use of Psilocybin Therapy for Patients with Cancer and Major Depression Disorder
Sunstone Therapies used to COMP360 to achieve positive results in a Phase 2 study on patients with cancer and Major Depression Disorder, published in JAMA Oncology.
Phase 2 data shows sustained response in 80% of patients and 50% of patients in full remission of depressive symptoms.
Clearmind Medicine Expanding IP Portfolio with New US Patent Application for Treatment of Depression
Clearmind announces the filing of a patent application seeking to protect its unique combination of MEAI and SciSparc’s Palmitoylethanolamide (PEA) for the treatment of depression.
The company filed a provisional patent application with the United States Patent and Trademark Office (USPTO) as part of its ongoing collaboration with SciSparc Ltd. (Nasdaq: SPRC) (“SciSparc”), a specialty clinical-stage pharmaceutical company focusing on the development of therapies to treat central nervous system disorders.
This patent is an addition to Clearmind’s robust intellectual property portfolio that includes patents for MEAI as a binge behavior regulator, as an alcoholic beverage substitute and others.
Silo Pharma Commences Formulation for SPC-15 Targeting Anxiety and PTSD Stress-Related Disorders
“We are advancing our development of SPC-15 through this formulation and feasibility study investigating dose strengths and delivery,” said Eric Weisblum, Chief Executive Officer of Silo Pharma.
“The SPC-15 treatment protocol predicts levels of severity or progression of stress-related disorders and their metabolomic biomarkers’ response to pharmacological treatments. Based on our own research to date coupled with published preclinical data, we believe SPC-15 could have a profound impact on treating stress and anxiety disorders including PTSD, we will further use this data to help us with our upcoming studies related to SPC-14 Alzheimer’s asset.”
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