Cannabis Tech recently interviewed Mira Pharmaceuticals CEO Erez Aminov and Co-Founder and President Dr. Adam Kaplin about Mira1a, a groundbreaking patented compound that mimics cannabinoids, shared an intriguing journey of what led to the development of a potentially revolutionary drug.
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Our conversation kicked off with the motivation behind the creation of Mira1a. Dr. Kaplin explained that while cannabinoids, like THC, are natural organic compounds found in plants, their effects, although desirable in many ways, can come with unwanted side effects for certain individuals, and it was this dilemma that led to the pursuit of an alternative.
“Cannabinoids are organic compounds derived from plants to prevent them from being eaten by predators – we just happen to be a predator that likes the effects we get from these plants,” Dr. Kaplin quipped.
Mira Pharmaceuticals’ founder embarked on an extensive journey, exploring 65 different chemical entities to create a novel compound with fewer side effects while preserving the therapeutic benefits of cannabinoids. The initial hope was that this new compound would be less likely to induce adverse side effects such as anxiety, paranoia, or cognitive impairment, common issues associated with THC.
Based on initial feedback, the scientific community is astonished by Mira1a’s ability to not only live up to these expectations but actually surpass them.
Mira1a a Revelation in Pharmaceutical Cannabinoid Compounds
Dr. Kaplin revealed a groundbreaking discovery – Mira1a significantly enhances cognitive performance while the treatment is active. While this heightened cognitive function is temporary and fades as the drug wears off, it represents a remarkable breakthrough.
“It makes your cognition better while you’re on the treatment, and that was dramatic. We’ve never seen anything that can acutely increase performance as much as this did,” Kaplin stated.
In contrast to THC, which can induce impairment, Mira1a demonstrated its unique ability to elevate cognitive function during treatment, making it an unprecedented development in cannabinoid-based compounds. “From a scientific standpoint, we see that mice -in tests of their memory and ability to express what they learned – do dramatically better.”
Dr. Kaplin referred to the results of extensive scientific research, particularly from studies conducted at Johns Hopkins University. These studies reveal that Mira1a’s effects on cognitive performance are astonishing. When tested on mice, Mira1a demonstrated the power to double their memory performance.
In a contextual association task, where mice learn to associate a specific box with a mild foot shock, Mira1a-administered mice exhibited a remarkable memory retention rate of over 50%, compared to only 25% in the placebo group.
What sets Mira1a apart is its acute administration – it doesn’t modify how you learn but instead augments your ability to utilize the knowledge already stored in your mind. The implications for humans, if this translates, are staggering.
“The idea would be, if it translates into humans, you don’t have to teach people new things based on what they already have stored in their mind,” Kaplin added.
Moreover, preclinical studies exhibited promising results in alleviating anxiety and pain without the typical side effects seen in traditional cannabis applications.
With this exceptional compound, the company is poised to redefine the future of cannabis-based therapeutics. As research continues and clinical trials progress, Mira1a may be a game-changer in medicine and cognitive enhancement, opening doors to new possibilities and treatment options.
Unlocking the Science Behind Mira1a
We asked Dr. Kaplin to explain the scientific intricacies that set the drug apart from traditional THC and indicate its cognitive benefits. He started by explaining the chemical composition of Mira1a.
Unlike THC, which comprises three 6-membered rings and a carbon tail, Mira1a features a distinctive structure, with one of its six-membered rings replaced by a 5-membered ring. The structural novelty renders Mira1a a unique entity never seen in nature or laboratories. Importantly, this novelty equates to a 20-year patent life, offering IP protection essential for pharmaceutical development.
Erez added, “I think we’re bringing something so marvelous, something so revolutionary, into the market that’s never been seen before.”
Pioneering the Path to Cognitive Enhancement and Beyond
During the interview, Erez explained the development phase of this novel compound. The goal is nothing short of remarkable – to not only address early-stage dementia and anxiety but also to enhance cognitive performance in individuals across the spectrum.
What makes Mira1a particularly intriguing is its broad appeal. Just as “Valium” was once dubbed “mom’s little helper,” Mira1a could become a sought-after aid for business professionals, students, and anyone seeking enhanced cognitive function.
The compound’s ability to improve cognition has already shown promise in preclinical studies, making it a tantalizing prospect for individuals looking to boost their mental faculties.
What sets Mira1a apart is its ability to deliver the therapeutic effects that people seek from THC and CBD without unwanted side effects. This differentiating factor positions Mira1a to potentially dominate the cannabis market, catering to those searching for cognitive enhancement and anxiety management.
But Dr. Kaplin explained, “We are not trying to be a part of the cannabis market. We hope to attract current users of medical marijuana to use Mira1a instead.”
Erez’s vision of widespread adoption suggests this compound may become an invaluable asset for individuals seeking that cognitive edge in their pursuits. “The average person is probably going to want this drug for the enhanced performance effects that are showing in the preclinical studies, and if we can prove that in humans, it will be a tremendous accomplishment,” he stated.
As Mira1a progresses through development and clinical trials, its potential to redefine cognitive enhancement and its impact on the cannabis industry remains to be seen.
A Game-Changer for Therapeutics
What sets Mira1a apart from traditional medical cannabis is its unique position as an unscheduled compound, a distinction that opens doors to a world of possibilities in the realm of therapeutic solutions.
Highlighting a significant milestone – Erez explained that Mira1a is unscheduled by the DEA. This distinction gives it an advantage over cannabis, which, as of today, is still classified as a Schedule I substance. Even with the latest news regarding the Schedule III recommendation by HHS as an unscheduled compound, Mira1a would still have a better opportunity to navigate the regulatory landscape.
However, this compound may be particularly significant for individuals who cannot use scheduled drugs due to federal regulations, such as federal employees or those subject to specific employment restrictions. Mira1a’s unscheduled status positions it as a viable alternative.
Ultimately, Erez envisions a future where healthcare providers like Dr. Kaplin can offer Mira1a as a cleaner pharmaceutical option to patients. Rather than dealing with the sometimes adverse, inconsistent effects and impaired cognition, doctors can prescribe Mira1a to alleviate symptoms without compromising cognitive function.
In essence, Mira1a doesn’t see the cannabis market as competition; it transcends it by offering a novel approach to therapeutic solutions. Its potential to capture significant market share while simultaneously addressing the needs of patients suffering from various conditions, including dementia, chronic pain, and anxiety, drives this mission forward.
Paving the Way for a Revolution in Healthcare
Dr. Kaplin acknowledged the importance of starting somewhere and recognized the pressing need within the elderly population. This demographic, often suffering from conditions like Alzheimer’s and dementia, can benefit immensely from Mira1a’s potential to alleviate behavioral symptoms without the adverse effects of conventional treatments and polypharmacy practices. He highlights the current use of marijuana for severe Alzheimer’s cases, a testament to the desperate search for solutions.
Dr. Kaplin’s emphasis on addressing the needs of the elderly, where benzodiazepine use is alarmingly high despite recommendations against it, underscores the urgency of introducing alternatives like Mira1a.But, the applications of this novel compound potentially extend far beyond the elderly population. Traumatic brain injuries, strokes, and various forms of cognitive impairment represent some of the many potential avenues where Mira1a could make a profound impact.
Mira1a’s Promising Profile: A Closer Look at Side Effects
A crucial aspect of any pharmaceutical development is, of course, the side effects. Dr. Kaplin offered his insights into the side effect profile of Mira1a and the early observations made during its development process.
Remarkably, at therapeutic doses where Mira1a has demonstrated its potential to improve anxiety and cognition in animal studies, no significant side effects have been observed thus far. This is a promising indication of the compound’s safety and effectiveness. However, it’s important to note that these studies have not involved chronic dosing, and further research, including safety analysis, is required before moving into human trials.
Dr. Kaplin made an intriguing observation during the research process. When mice were administered excessively high doses of Mira1a, they exhibited a peculiar behavior – a form of sedation where they would sit with splayed legs and an apparent sense of relaxation. While this behavior is intriguing, it occurred at doses far beyond what would be considered therapeutic. Therefore, it serves as a reminder of the importance of proper dosing and monitoring in the clinical application of Mira1a.
Comparatively, Dr. Kaplin highlights a notable difference between Mira1a and THC. THC has been associated with catalepsy in mice, a state of rigid immobility akin to a statue. Catalepsy is a phenomenon that can be observed in humans with psychotic symptoms and has previously raised concerns regarding the safety of THC. Mira1a, even at equivalently high doses, showed no signs of inducing catalepsy in the animal models.
Dr. Kaplin aptly states, “All drugs are toxins, but some have therapeutic effects.” Thus far, Mira1a has demonstrated a promising therapeutic profile with minimal observed side effects at therapeutic doses. Further research and human trials are necessary to provide a better understanding of its safety and efficacy.
Charting the Path Forward: Mira1a’s Journey to the Masses
Looking forward, CEO Erez provides a glimpse into the next steps in Mira1a’s journey after reaching this significant milestone and making it accessible through a recent press release.
The primary focus for the team now is the continued development of Mira1a. Erez emphasized the company’s commitment to advancing this groundbreaking compound through the clinical trials and regulatory processes required for approval. Key milestones include Investigational New Drug (IND) submissions and initiating Phase 1 and Phase 2 clinical trials.
“The goal is to get through scaling up manufacturing of Mira1a, completing safety/tox/tolerability studies in animals, and then trying to initiate a Phase 1 study in 2024. Phase 2 studies are not anticipated starting until 2025,” Dr. Kaplin stated.
However, he also underscores that their ambitions extend beyond the initial stages of clinical trials. Recognizing the profound potential of Mira1a, the team is actively seeking collaborations and potential partnerships to ensure broad access to the compound.
“We’re going to be looking for collaborations with other entities to potentially advance this drug through the market,” Erez indicated. “We’re very excited about getting this through to the FDA regulatory process.”
Accessibility and Addressing the Challenge of Cost
Dr. Kaplin recognizes some medicine options can be prohibitively expensive. Discussing the intricacies involved in CBD production, he pointed out the need for secure farms, cultivation, and extensive purification processes to isolate the compound from other cannabinoids in hemp.
To this point, Dr. Kaplin emphasized that the process for manufacturing Mira1a is fundamentally different. It involves modern manufacturing techniques and is poised to be more cost-effective than the laborious and resource-intensive process required for plant-based products.
“The cost of manufacturing will be far less than the cost of growing, harvesting, securing, and purifying plant-based products,” he stated.
CEO Erez also mentioned the company’s vision for managing costs. Acknowledging the streamlining and scaling-up efforts underway, he suggests that Mira1a, covered by insurance, could be as little as a $5 co-pay.
In the quest for cognitive enhancement and the development of novel therapies, Mira1a stands at the forefront, a testament to scientific ingenuity and limitless possibilities. As a potential treatment for early dementia or cognitive decline, Mira1a may enhance cognitive performance and perhaps even reclaim lost abilities.
As the compound progresses through its development and regulatory phases, it is clear that both affordability and effectiveness are central to the mission of making Mira1a available to patients suffering from anxiety, chronic pain, and cognitive impairment.
“We have an exit-based strategy – focus on drug development, then attract collaborations or a bigger pharmaceutical company to acquire it as a clear entry point for pharma in the cannabinoid space,” Erez stated.
As research continues, this compound could redefine how we perceive and harness the power of the endocannabinoid system, opening doors to a future where personalized medicines pave the way to proactive healthcare.
