Mind Medicine Inc. (MNMD.Q) Stays Focused and Launches Phase 2a Trial of LSD for ADHD Treatment

  • $ 901.372M Market Capitalization

Mind Medicine Inc. (MNMD.Q) today announced the launch of a Phase 2a Proof of Concept (POC) trial of lysergic acid diethylamide (LSD) in adult patients with Attention Deficit Hyperactivity Disorder (ADHD). POC clinical studies are an early stage in clinical drug development where a compound has demonstrated potential for human therapeutic use. A POC clinical study takes place after preclinical animal models and early safety testing. From this perspective, POC clinical studies play a central role in enabling a company to progress towards the commercialization of viable human therapeutics.

ADHD is one of the most common neurodevelopmental disorders in children, according to the Centers for Disease Control and Prevention. Children with ADHD usually have difficulty concentrating and behaving at one point or another. In addition, the symptoms can be severe, causing difficulty at school, at home, or with friends. Common symptoms include restlessness, forgetfulness, and careless mistakes, to make just a few. In 2016, the estimated number of children diagnosed with ADHD was 6.1 million.

Keep in mind that children with ADHD don’t just grow up because of their behaviors. Some adults who experienced milder ADHD symptoms as children may have developed coping skills to prevent ADHD from interfering with their daily lives. However, many adults living with ADHD face many challenges, including debilitating struggles with time management, impulsivity, mood swings, and disorganization. According to MindMed, out of an estimated 10 million American adults living with ADHD, only 10.9% seek and receive treatment for their condition.

On the contrary, a 2014 national survey found that nearly 9 in 10 children had received some type of behavioral treatment or vocational training. Meanwhile, between 2007 and 2016, the rate of ADHD in adults increased dramatically. 123%. In addition, the diagnosis of an adult with ADHD requires at least five symptoms of inattention, hyperactivity or impulsivity, according to the Diagnostic and Statistical Manual of Mental Disorders of the American Psychiatric Associations (DSM-5). When it comes to treatment, apparently, it takes more than just a beater to curb ADHD symptoms in adults and children.

For adults, ADHD treatments include medication, education, job training, and psychological counseling. A combination of these various treatment options is often the most effective, however, it does not cure ADHD. With this in mind, LSD has demonstrated its potential in various studies for therapeutic use. LSD was studied from the 1950s to the 1970s to assess changes in behavior and personality, as well as remission of psychiatric symptoms in various disorders. Specifically, LSD has been used to treat anxiety, depression, psychosomatic illnesses, and drug addiction.

“Psychedelics, including LSD, have been shown to have beneficial and lasting effects on mood when given in single doses that produce psychedelic effects. There is anecdotal evidence of the possible benefits of low to very low doses of psychedelics given repeatedly. This is the first controlled study to validly assess the therapeutic effects of very low doses of a psychedelic in patients, ”commented Dr. Matthias Liechtenstein, Basel University Hospital and co-principal investigator of the trial.

LSD has been shown to be effective in treating neurotic symptoms, heroin use disorders, anxiety associated with life-threatening illnesses, and drug use disorders, according to a study published by Frontiers in Psychiatry. ‘alcohol. Overall, the study recognized the therapeutic potential of LSD in reducing psychiatric symptomatology. In fact, a majority of authors have described important short term changes in patients. With this in mind, through a Phase 2a POC trial, MindMed will further explore the therapeutic value of LSD in the treatment of ADHD.

The Phase 2a POC trial is a multicentre, randomized, double-blind, placebo-controlled trial evaluating the safety and efficacy of low-dose LSD as a treatment for ADHD in adults. The trial aims to enroll a total of 52 patients who will receive 20 micrograms (µg) of LSD at each dose or placebo for 6 weeks. the main evaluation criteria are a mean change from baseline in ADHD symptoms, as assessed by AISRS after 6 weeks of treatment. The POC trial will be carried out in collaboration with the University Hospital of Basel in Switzerland and the University of Maastricht in the Netherlands.

“We have designed a robust randomized clinical trial to replicate and extend the promising results of smaller, open-label trials conducted previously. This trial will evaluate our treatment regimen in a tightly controlled setting and help optimize dosing regimen, compound selection and clinical management. Additionally, this trial will provide additional information on the mechanisms by which psychedelics exert their therapeutic effects, ”said Dr Miri. Halperin Wernli, executive chairman of MindMed.

The trial will be led by Dr Matthias Liechtenstein, University Hospital Basel, Switzerland, and Dr Kim Kuypers, Maastricht University, The Netherlands. It should be noted that the global ADHD therapy market is expected to reach 45.68 billion US dollars by 2026, up from US $ 29.56 billion in 2021. This market is growing at a compound annual growth rate (CAGR) of 9.09%. The growth can largely be attributed to the frequency of ADHD increasing at a higher rate. Besides, increasing advancements in medical field, research and awareness is expected to fuel the market growth considerably.

According to MindMed’s second quarter 2021 financial statements, the company had cash of $ 157,036 as of June 30, 2021, compared to $ 80,094 as of December 31, 2020. As of June 30, 2021, MindMed had total assets and total liabilities. of USD 193,869 and USD $ 17,466, respectively. In comparison, as at December 31, 2020, the Company had total assets and total liabilities of US $ 85,644 and US $ 2,377, respectively.

For the quarter ended June 30, 2021, MindMed’s research and development expenses increased to $ 4,667 from $ 2,700 as of June 30, 2020. In total, for the quarter ended June 30, 2021, the Company reported a net loss of USD 35,575 US $ 5,757 for the quarter ended June 30, 2020. For the six-month period ended June 30, 2021, these figures translate to US $ 51,146 and US $ 12,778, respectively.

MindMed’s stock price opened at $ 2.16, from a previous close of $ 2.11. Shares of the company are up 1.42% and were trading at $ 2.14 as of 12:31 p.m. EST.

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