Early Pilot Study Data from Veteran Volunteers is Compelling
Jackson Center, PA September 4, 2024 - PRISM MediaWire - Halberd Corporation (OTC: HALB)
To our shareholders:
As promised, this is the second of three Press Releases on our recent progress. If you have not had a chance to review that last one, on the good news on our Tri-aX™ Nasal Spray for TBI, please do. This one follows the same process. This Press Release is focused on LDN+, as related to Post Traumatic Stress Disorder (PTSD) and Veteran Suicide Reduction. To facilitate some feedback we have received from our investors, we are doing this one in two parts.
This is Part A. Hope this does not confuse anyone. Part B will be released in a few more days. As always, reach out to us if you have any comments or thoughts. Good or bad, we appreciate them!
The PTSD market is evolving with advancements in treatment options, increased awareness, and growing demand for supportive services, reflecting the critical need for comprehensive care for individuals affected by PTSD. The field of invention of our evolving intellectual property (IP), now referred to as WatchDawg™, is combining the patented drug (LDN+) with adjunct therapies and monitoring. In recent months, after three losses in proposed efforts to the Department of Defense (DoD) on LDN+, we recognized that we were not getting the attention of the military on LDN+ alone, and it was widely published that there was no medical “cure” for PTSD or any other form of mental illness. However, we did some in-depth analysis and concluded a combination of approaches in parallel to drug therapy may offer patients hope. We have evolved to the term LDX as an advanced LDN+ therapy-based pharmaceutical and bolstered adjunct therapies and a novel 24/7 patient monitoring technology. This was a game changer, and we recently won military interest. More on that later.
The pilot program started weeks ago now as has been reported. It looks like our solution is working and working well. Our preliminary clinical use data on the compounded formulation (LDX), based on a major modification of a patent describing LDN+, with a diverse patient targeted demographic. Contrary to issued patents on LDN+, by Dr. Mitchell S. Felder, we now believe that the choice of LDN based therapy as a novel drug therapy alone will simply not work. Of course, that can be argued, but the data obtained in our pilot study to date refutes that. So, over the last few months and especially as we began the pilot program, we adapted. The chosen therapies must be adjunctive to a comprehensive approach. The pursuit of FDA clearance to market LDX is evolving through FDA guidance, a solid regulatory consultant group, and the Institutional Review Board (IRB) inputs and directions. The plan is to move into safety and efficacy trials as quickly as possible on the pharmaceutical while continuing the marketing and distribution of the WatchDawg™ product with LDX as a “compounded solution” or as simple dual drug therapy of the FDA cleared subcomponents of LDX, with a selected number of nutraceuticals, psychological support services, proven Exalted Warrior yoga and meditation therapy, and 24/7 physiological monitoring of participants, to supplement the therapeutic interventions.
Combined Invention. What this invention includes, and is now submitted as a provisional patent, and unique to the markets, is a combination of low doses of FDA cleared components, pharmaceutical use, CBD/CBN-based nutraceuticals, monitoring and therapy within a patient portal of 24/7 connectivity between care providers and patients. When used in combination, the approach is uniquely suited to address various disease states common to man, while not relying on FDA clearance. Our compiled data indicates it is working. Early trends are lower subject heart rates, lower stress levels, improved heart rate variability (which is good), higher sPO2, and most interestingly, the data shows a significantly reduced data volatility (more stable physiology) in vital signs on therapy as opposed to baseline data before therapy. The differences in these minimal patients so far is compelling!
This is now suggesting a much closer-term revenue generation model earlier than projected, while the FDA clearance in parallel moves through the various stages. At this point the main desire is to avoid a classic Investigational New Drug (IND) FDA classification, and 3+ years and a large cost, in exchange for a simpler approach. This is good because we simply do not have the money. With the staggering data on the number of veteran suicides per day, it made sense to follow FDA guidance and also get to market faster without any presumed violations. What this invention describes is a nearer term, lower risk, lower cost alternative to an IND. Since the pharmacy does not require FDA clearance if either administered as separate capsules or pills, or compounding into a single capsule under applicable FDA guidelines for compounded pharmacy, it makes sense to move ahead for now without an IND or requisite FDA clearance as a prerequisite.
Core market. We entered this new business strategy with the idea of helping to lessen the incidence of veteran suicide. An enduring result of war is development of Post Traumatic Stress Disorder (PTSD), and concomitant mental health issues in our veterans. PTSD is not only seen in veterans but in the general non-military populations as well. As of 2024, the Global Market for Post-Traumatic Stress Disorder (PTSD) Treatment and Managementwas estimated to be approximately $12 to $15 billion. The Compounded Annual Growth Rate (CAGR) for the PTSD treatment market segment is projected to be approximately 8% to 10% over the next few years. This growth rate is high and reflects the increasing demand for more effective PTSD treatments and interventions due to various factors. This market includes various components related to the diagnosis, treatment, and support for individuals suffering from PTSD and other related mental health issues as well as substance abuse, anger, anxiety and depression.
Key Components of our WatchDawg™ Approach for the PTSD Market:
- Pharmaceuticals: Standard clinical treatment includes antidepressants (such as SSRIs and SNRIs) and anti-anxiety medications used to manage the symptoms of PTSD. Specific drugs like sertraline and paroxetine are commonly prescribed. We have developed LDN+ and now LDX, and add other therapies associated with nutraceuticals based on CBD/N.
- Therapeutic Services: Various forms of psychotherapy, including Cognitive Behavioral Therapy (CBT), Eye Movement Desensitization and Reprocessing (EMDR), and trauma-focused therapy, have been established as critical components of PTSD treatment. This often includes individual counseling, group therapy, and peer support programs designed to help individuals manage and recover from PTSD. We have added our proprietary blend of yoga and meditation found to be particularly effective on veterans lucky enough to experience Exalted Warrior’s technique.
- Digital Health Solutions: Apps for managing PTSD symptoms, providing therapy exercises, and offering mindfulness and relaxation techniques are now increasingly common. We support that. However, we are different. The industry is now releasing telehealth services, i.e., remote therapy and counseling services that provide accessibility and convenience for individuals seeking treatment for PTSD. We have added the WatchDawg near-real time (NRT) vital signs monitoring platform, and the App via a cloud-based platform. In addition, we have developed the PAWS system architecture and launched this as part of WatchDawg. In Part B we will explain this in detail.
- Support and Rehabilitation Programs: Veteran and Military Programs have specialized programs and services for veterans and active-duty military personnel, including VA facilities and military-focused PTSD treatment programs. In addition, Trauma-Informed Care Programsincorporate trauma-informed approaches to provide supportive care for individuals affected by PTSD. All in, the combination of what we offer with WatchDawg™ through our cloud-based APP exceeds what is available on the market today.
- Research and Development: We also know there are numerous research programs focused on developing new treatments, therapies, and interventions for PTSD as well as other mental health issues. These include studies on novel medications, therapeutic techniques, and digital health interventions. We are now well underway in a pilot study, transitioning soon to Phase 1 and then a comprehensive 150 participants in a safety and efficacy study on the combination of WatchDawg monitoring, and therapies.
In Part B we will expand into these areas more and describe the approach and our recent successes with the military. So far, we have evidence now that we are on the right pathway forward and are also well ahead of the timeline originally envisioned to get this to market. Rarely does a day goes by now that some other veteran or addict calls us or texts/emails us that they heard about our work and wants to participate.
William A. Hartman and Dr. Mark Darrah
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About Athena GTX, Inc.
Athena GTX is a certified DoD small business with Corporate Headquarters in Johnston, Iowa. Athena focuses development on wearables and highly mobile, wirelessly connected monitoring technologies, and transitioning those to key markets to meet unmet needs of first responders worldwide. Wireless Patient Monitoring – Athena GTX connects patient and provider About - Athena GTX® Inc.
About Halberd Corporation.
Halberd Corporation (OTC: HALB) is a publicly traded company on the OTC Market, and is in full compliance with OTC Market reporting requirements. Since its restructuring in April of 2020, Halberd has obtained exclusive worldwide rights to three issued patents and has filed 22 related provisional, PCT, or utility patent applications to enhance its value to its stockholders and to attract the interests of potential development partners.
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Source: Halberd Corporation