Philip Young | CEO, Lobe Sciences

What first got you excited about psychedelics and their therapeutic potential?

The challenge of developing new drugs for millions of patients in dire need of effective and safe treatments.  For over 30 years I have successfully worked in Biotech developing novel compounds for a variety of diseases with few if any treatment options available for patients.  Through the years my teams and I have always created a work environment that was patient centered and patient focused.  The psychedelic revival is offering millions of patients the opportunity to receive therapies that may play a major role in alleviating long standing and sometimes crippling symptoms.  These drugs have been around since the time of man dwelling in caves and have been used therapeutically and recreationally since that time. We know that we are working on compounds that should be safe and it is up to us to prove that they are effective in our chosen indications.  Efficiently taking mostly naturally occurring compounds and developing them into pharmaceutical products is the challenge facing all psychedelic companies.  I know that my team's successful experience over decades of developing drugs gives us an advantage which we believe will drive the development and eventual Regulatory approval of our treatments for mTBI, PTSD and other diseases in need of effective treatments.

What is Lobe Sciences working on building?

We are building a multinational Biotech company committed to improving the brain and mental health of patients around the globe.  As mentioned, we take a patient centric approach.  How can we best serve the patient where he or she lives?  Many Companies are taking an approach where they believe that patients will best respond to psychedelic (trip inducing) levels of drug administered under the watchful eye of a trained therapist in sessions that can last 8+ hours.  While some indications may benefit most effectively from this approach, we believe that we can identify a sub psychedelic but therapeutic dose of psilocybin for example and administer it over a period of days.  Treating the millions of patients suffering from mTBI and PTSD will be best done where the patients live, work and play.  By approaching the market and patients using this strategy gives Lobe the best opportunity to develop and launch drugs targeting a global market while creating significant shareholder value.

What psychedelic molecules are you investigating and for which indications?

We are currently working to develop a combination therapeutic regimen combining psilocybin and/or MDMA with NAC (N-Acetyl Cysteine).  NAC is a very well characterized supplement, originally FDA approved for treating Acetaminophen poising. We believe that the combination of these treatments will give a more robust therapeutic response than either used alone.  In fact, we plan on initiating our human clinical trials this year (2022), starting with Phase 1a and 1b trials designed to demonstrate the safe administration of our products while identifying the optimal dose to take forward into Phase 2 study in mTBI and PTSD. It is exciting that we have advanced as rapidly as we have and plan to file the IND with the FDA to allow us the ability to initiate further clinical trials in the USA.

Can you share with us what potential psilocybin holds as a molecule for therapeutic purposes and what validation you have seen of it clinically?

There have been hundreds of publications, some in peer review medical journals documenting the beneficial effects of psilocybin.  It is one of the most studied psychedelic drugs and is it likely the oldest, so the knowledge base is broad and deep.  Science is starting to be able to discuss the actual interactions or signaling this molecule achieves as it activates in the brains of patients.  We know from the literature and thousands of years of anecdotal reports that psilocybin is safe and non-addictive. In fact, there are now animal models demonstrating the psilocybin’s ability to generate and maintain many new neuronal connections.  Our initial preclinical data testing our patent pending combination therapy with NAC indicates that there is positive potential of our therapeutic compounds in mTBI and PTSD.  We plan to further explore this in our first human studies this year.

Can you share more about Lobe’s partnership with the World Boxing Association and the NFL Alumni association and how it will work to address patients with mTBI?

Both organizations are committed to improving the lives of their constituents who have suffered from the impact of Traumatic Brain Injuries.  The medical community, including the United States Military are just now beginning to understand the long lasting, sometimes devastating impact of mild to severe concussions (mTBI or TBI). We will be working with the staff at each organization to identify commonalities that will support the building of an international registry that will track those affected by TBI.  Eventually we hope this Registry will become a tool that will allow the identification of participants for clinical studies and eventually treatment with FDA approved therapeutics developed by Lobe Sciences.

 Can you discuss your collaboration with Virtual Psychedelics to develop the Krysalis System?

We are very excited to be working with a team of media futurists, system innovators, and medical thought leaders as we develop the Krysalis therapeutic XR system.  We will be leading the way in the newly minted Metaverse.  Our plans will allow treating physicians to use original and aggregated immersive healing content in conjunction with psychedelic drugs administered during targeted counseling sessions.  In addition to the psychedelic aided sessions, we believe that additional content targeted at virtual counseling sessions between patient and therapist will grow in adoption as the true value of the Virtual Reality centered Krysalis System is built and realized.  The Krysalis System will be fully interactive and will be able to monitor, gather and respond to the biometric data of each and every patient.

What do you see the pathway being for psychedelics to becoming medically accepted and accessible?

I think the pathway for acceptance of these new therapies begins with our responsibility to appropriately develop them as FDA regulated medicines.  When I say FDA, I am speaking of all the global regulatory bodies.  In general, if we satisfy the FDA, we will satisfy the requirements of the rest of the world’s Regulators.  Given the checkered history of psychedelics it is natural that some percentage of the population will be skeptical.  Especially when there are news stories about localities around the North America decimalization of legalizing the recreational use of various psychedelics.  These products are not manufactured to strict cGMP standards and will never be mainstream. We will implement the development of our therapies to the highest standards.  Publishing data as we generate it and communicating the effects of treatment in the target populations will also help drive a positive public sentiment about the potential for these therapies.  Demystifying and differentiating our pharmaceutical approach to recreational use is all part of the plan and is needed for the industry to succeed.

What do you see the future of psychedelic medicines being and what will their impact be on healthcare as a whole?

The future of psychedelic medicines is unlimited.  Analysts forecast that the psychedelic market will be counted in the tens of billions of dollars or more.  I believe that to be the case.  The initial concentration on treating patients who have largely been ignored or poorly treated with poorly designed me-too ineffective therapies presents a tremendous opportunity.  From Depression, PTSD, mTBI, OCD to alcohol abuse and postoperative pain disorders to name a few, there is much work to be done. We will see significant breakthroughs in the next several years which will generate increased interest in psychedelics and drive the long term success.

 What excites you the most about Lobe’s future? 

We are just starting!  We became Lobe Sciences just a year ago and have made great strides to position our company for great success in 2022 and beyond.  I truly believe that the future of psychedelic medicines begins with identifying the appropriate diseases and paring the correct pharmacologic activity needed to attenuate symptoms and potentially cure the patient.  In pursuit of those goals in 2022 we will announce the initiation of human clinical trials, and IND with the FDA, complete control of manufacturing our products and New Chemical Entities (NCE) for the treatment of our targeted indications, mTBI and PTSD and additional indication(s).  We are building plans that will allow us to rapidly move through our initial clinical studies geared to provide data that supports our therapeutic hypophysis. The psychedelic and the larger Biotech markets in general suffered negative stock pressure through the end of 2021 and into early 2022.  We believe that following our plans and communicating our results to the Markets and Medical community will drive our shareholder value and position Lobe as a leader in the psychedelic sector and larger biotech marketplace.