Maghsoud Dariani | Chief Science Officer, Lobe Sciences

Mr. Dariani is the Chief Science Officer at Lobe Sciences and has significant experience as an entrepreneurial business leader with a strong background in technology development. Concurrent to leading science and technology efforts at LOBE, Maghsoud is also President and CEO of Semorex Inc. – a privately held company focused on the discovery and development of novel therapeutics for cancer. Prior to joining Semorex, Dariani was President of Focus Pharmaceuticals, Inc., where he managed the development and approval of drug products, achieving one FDA approval and bringing another to the clinical evaluation stage, then successfully negotiated the sale of the company in February 2003. Prior to Focus, Maghsoud was Vice President of the chiral pharmaceutical business unit at Celgene Corporation. During his twelve years at Celgene, he was responsible for the successful development and FDA approval of the chirally pure versions of Ritalin, which are currently marketed by Novartis under the Focalin and Focalin XR trade names.

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How would you summarize Lobe’s strategy in its simplest form? What makes Lobe’s strategy unique among other psychedelic drug discovery companies?

‍Lobe's strategy is to develop safe and effective psychedelic based therapeutics for treatment of neurological disorders with unmet needs.  Our unique approach to achieving our strategic goal is to i) use a combination of two compounds that have shown efficacy towards neurological disorders; ii) develop a proprietary device for delivering our drugs to the brain via nasal cavity; and iii) develop an effective micro-dosing regimen that may eliminate the requirement for a whole day psychotherapy in conjunction with psychedelic drug administration currently used by other companies.

What got you personally excited about psychedelics? 

Having a family member suffering from PTSD for a long time and numerous other friends suffering from drug resistant depression were the impetuses for my excitement about psychedelics as potential therapeutics for the treatment of neurological disorders.

What similarities do you see in the development of novel psychedelic medicines and novel therapeutics for cancer? ‍

Developing a novel psychedelic therapeutics for neurological disorders entails similar steps to developing novel cancer therapeutics.  You have to show these drugs are safe and effective via rigorous pre-clinical studies followed by human clinical trials to get approvals from regulatory authorities such as US Food and Drug Administration (FDA) and European Medicines Agency (EMA).

How do you see these medicines helping people suffering from PTSD or mild traumatic brain injuries?

‍Psychedelic drugs have shown efficacy in treating various neurological disorders in research studies and early stage human clinical trials, for example in drug resistant depression, anxiety, obsessive compulsive disorders, addictions, and PTSD.  There are no effective drugs for treating most of these disorders.  Psychedelic medicines under development hold the promise of helping millions of people throughout the world who suffer from neurological disorders with unmet needs.

Can you share where your clinical trials are currently at in psychedelics? ‍

We anticipate starting our human clinical trials towards the end of 2021 or early 2022.  We are currently conducting pre-clinical studies to confirm safety and efficacy of our combination drugs in established models of PTSD and mild traumatic brain injury (mTBI).

What advantages would you say you currently have in developing a psychedelic medicine? ‍

As I mentioned earlier, we have a three prong strategy in developing our psychedelic drugs that places us in an advantageous position relative to others who are developing psychedelic medicines.  First, we are developing a treatment that combines two compounds that have shown efficacy towards neurological disorders.  We believe the synergy from combining these compounds will result in superior efficacy.  Second, we intend to develop a micro-dosing regimen that should eliminate the need for a whole day psychotherapy in conjunction with the administration of psychedelic drugs that is currently being used by other companies.  Finally, we are developing a proprietary handheld device for delivering our combination drugs to the brain via nasal cavity which eliminates first pass metabolism and gets the drug to its site action rapidly.

Lobe has started pursuing pre-clinical trials for a combination treatment utilizing NAC and Psilocybin for PTSD and mTBIs, how does the combination of those drugs work together to help patients? ‍

Majority of patients who experience mTBI, end up having PTSD.  Trauma to the head, results in inflammation and pressure build-up in the skull which then initiates a cascade of events which result in elevated levels of reactive oxygen species and inflammatory cytokines that damage brain cells.  Taking NAC increases the level of glutathione, a potent antioxidant and anti-inflammatory molecule, in cells.  Glutathione’s function is to protect cellular components and prevent damage to them from reactive oxygen species and inflammatory cytokines.  Administering NAC plus psilocybin together, prevents damage to brain cells resulting from mTBI and alleviates symptoms of PTSD by increasing the release of serotonin thereby improving mood, enhancing sense of well being, reducing anxiety, and enabling willingness to discuss and forget emotionally charged memories.

What are the benefits of a nasal mist spray? Does a Nasal Mist Spray offer more precision and efficacy of dosing? ‍

Upper regions of nasal cavity adjacent to the olfactory bulb is an ideal location for administration of CNS acting drugs that easily cross blood brain barrier which is the case for psychedelic drugs.  Ordinary nasal sprays do not deliver their contents to this region.  Our plans are to develop a proprietary nasal mist device which will deliver its content to the upper region of the nasal cavity near the olfactory bulb. This method of administration will eliminate the first pass metabolism and get our combination drug to its site of action in the brain faster.  We believe using this device will result in a lower dosage of the psychedelic drug with more precise delivery to its site of action.

What is memory odor imprint pairing? ‍

This relates to one of our patent applications and I can't get into much detail about it now.  Suffice it to say that this refers to a method of avoidance of memory recall by an odor similar to a Pavlovian response.

What is the most common misconception you hear about psychedelic medicines? ‍

As most people are aware, psychedelic compounds such as ecstasy (MDMA), acid (LSD), and magic mushrooms (psilocybin) were abused frequently in the 1960s and were portrayed as "recreational" or party drugs that are harmful and dangerous.  This is why they became illegal and controlled substances.  Many scientists believe this label is unwarranted. In clinical research settings around the world, renewed investigations are taking place on the use of psychedelic substances for treating illnesses such as addiction, depression, anxiety and post-traumatic stress disorder (PTSD). We believe that these drugs can be effective and safe therapeutics as adjuncts to existing psychotherapeutic approaches.

How do you see psychedelic medicines making an impact on healthcare as a whole in the future?

‍There are millions of people throughout the world who are suffering from neurological disorders without an effective drug to treat them.  Successful development of psychedelic based drugs for treatment of these disorders will help these people to live a normal life and in addition will eliminate billions of dollars in lost productivity from people who suffer from these debilitating neurological disorders.  As an added bonus, successful development of psychedelic medicines will result in significant savings for the healthcare systems throughout the world, which are spent on treating the symptoms rather than the underlying neurological diseases.

Who is someone doing important work in the world of psychedelics that you think more people should be aware of?

A few names that come to my mind immediately:  Dr. Roland R. Griffiths, Ph.D., Professor in the Departments of Psychiatry and Neurosciences at the Johns Hopkins University School of Medicine; Dr. Mark A. Geyer Ph.D., Distinguished Professor of Psychiatry and Neurosciences Emeritus at the University of California San Diego (“UCSD”); Dr. Rick Doblin, Ph.D., Founder and Executive Director of Multidisciplinary Association for Psychedelic Studies (MAPS); and Dr. Robin Carhart-Harris, Head of the Center for Psychedelic Research, Division of Brain Sciences, Faculty of Medicine, Imperial College London.