At last check, the Mind Medicine stock is up 3.16 percent in premarket trading and could continue to rise as researchers look at the effects of LSD on anxiety, pain, and adult ADHD. If the company continues to succeed, it might get access to multibillion-dollar mental health markets, such as the $4.7 billion anxiety industry and the $9.5 billion ADHD market.
The R(-)-MDMA Program by MindMed adds to the company’s drug development pipeline
The initiation of a program to produce R(-)-MDMA for the treatment of social anxiety and functioning in diagnoses such as Autism Spectrum Disorder has expanded the pipeline of a major biotech business developing psychedelic-inspired treatments (ASD). This program represents a significant expansion and diversity of MindMed’s pipeline, and it advances the company’s aim of developing novel solutions that help patients and meet unmet medical needs.
ASD is characterized by social anxiety and deficits in social functioning, and it affects about 2% of people in the United States. There are currently no authorized medicines for ASD’s basic symptoms, and there is a substantial unmet need for innovative medications to help persons with the disorder. The expense of ASD is expected to reach $461 billion in the United States by 2025, underscoring the need for and possibility for innovative therapies. According to the National Institute of Mental Health, roughly 12% of the general population in the United States suffers with Social Anxiety Disorder at some point in their lives.
MDMA, a racemic combination of two physically distinct stereoisomers, R(-) and S(+), is being developed for the treatment of Post-Traumatic Stress Disorder (PTSD), and has shown statistically significant favorable outcomes in a crucial Phase 3 experiment. In addition, participants with ASD demonstrated strong and statistically significant improvements in social anxiety and functioning after receiving short-term MDMA treatment in a pilot clinical experiment.Preclinical data suggests that the R(-) enantiomer of MDMA retains the acute pro-social and empathogenic advantages of racemic MDMA while exhibiting fewer symptoms of stimulant action, neurotoxicity, hyperthermia, and abuse liability. This favorable profile suggests that R(-)-MDMA could be used for purposes other than racemic MDMA, such as novel, more accessible delivery modes and repeat dosing.
In terms of safety, the business has high confidence in the R(-) enantiomer, owing to its positive preclinical pharmacology and the amount of prior human dosing of the racemic combination, which provides valuable insight into R(-)-MDMA’s projected safety and tolerability. MindMed intends to progress its R(-)-MDMA development program in the United States and the European Union, with the first clinical trials expected to begin in 2022. MindMed and the Liechti Lab at University Hospital Basel (UHB) propose to start a comparative pharmacokinetics and pharmacodynamic clinical trial of R(-)-MDMA, S(+)-MDMA, and R/S-MDMA in 2022 as a major initial investigation.
This double-blind, placebo-controlled crossover trial in healthy volunteers will investigate differences in acute and long-term effects of MDMA and its two enantiomers, and will give crucial information on the best treatment paradigm for R(-)-MDMA.
Q2 Financial Results 2021
As of June 30, 2021, the company’s total assets were $194 million, including $157 million in cash. For the quarter ended June 30, 2021, net cash used in operating activities was $12 million. For the quarter ending June 30, 2021, there was a net and comprehensive loss of $36 million.
Sphere Health and MindMed have announced a strategic research collaboration
Sphere Health, a physician-founded employee benefits provider focused on treatments for people with severe mental illness, has agreed to collaborate with a leading biotech company developing psychedelic-inspired therapies to collect and analyze multimodal data in order to improve the understanding of a variety of biomarkers associated with mental illnesses such as anxiety and affective disorders.
MindMed and Sphere Health are collaborating on MM061302, a project that will employ existing consumer technologies to create a robust data collection that can be used to generate more accurate machine learning techniques to detect biomarkers that are associated with and predict anxiety and depression symptoms. The findings of the study can be utilized to better understand mental health diseases and may aid in the development of future digital technologies to help both people with mood disorders and the professionals who care for them.
Study data can also be de-identified and linked at the subject-level to other data sets, preserving patient privacy while providing additional insights based on real-world data, thanks to a collaboration with MindMed’s colleague Datavant.
