In this interview, we engage with Dalton Signor, CEO at Miist Therapeutics, to explore their innovative inhaled therapies for migraines and smoking cessation. With a focus on rapid drug delivery and enhanced patient outcomes, Miist Therapeutics is set to redefine treatment standards. This discussion unveils the unique methodologies and promising results that distinguish their therapies from traditional options.
Moe: How are Miist’s trials designed to measure the safety and efficacy of your inhaled therapies?
Our clinical trials are meticulously crafted to focus on safety, pharmacokinetics (PK), and early efficacy. A standout feature is our use of arterial sampling, which is somewhat unique in the industry. This method allows us to accurately capture the rapid absorption of our inhaled therapies, which is crucial given our delivery system. For example, in our phase one study, we conducted arterial draws at intervals as short as 30 seconds, yet we found that the peak absorption occurred even before this mark. This rapid absorption is pivotal for achieving quick symptom relief, as demonstrated by our 92% symptom relief within two minutes for smoking
cessation. This approach provides a comprehensive understanding of the drug’s behavior in the body and sets a new standard for evaluating inhaled therapies.
Moe: How do Miist’s inhaled therapies compare to current treatments for migraines and smoking cessation?
Our therapies offer a significant leap forward in both speed and efficacy. For smoking cessation, existing products like gums and lozenges are marketed as quick-acting but take 30 to 50 minutes to provide relief. This delay is problematic because the average person relapses within 11 minutes of experiencing cravings. Our inhaled therapy, however, reaches peak concentration within 30 seconds and provides 92% symptom relief within two minutes. This rapid response is crucial for preventing relapse. Similarly, for migraines, most treatments are oral and can take up to two hours to reach peak concentration due to delayed gastric emptying. Our inhaled therapy delivers the drug to the brain almost instantaneously, allowing us to address the migraine before it fully develops. This improves patient outcomes and highlights the potential of inhaled therapies to revolutionize treatment paradigms.
Moe: Can you elaborate on the adverse reactions or potential side effects observed during your studies?
The safety profile of our inhaled therapies is quite favorable. For smoking cessation, the adverse events were minimal and expected, such as coughing and throat irritation, which are typical of inhaled nicotine. Importantly, we observed no serious adverse events. One key to our strong safety profile is our aerosol generation method, which uses vibration, not heat. Since we don’t use any heat in our aerosolization process, we avoid the creation of any undesirable or dangerous byproducts. Patients who use our aerosol therapies are only inhaling small water droplets that contain our active pharmaceutical ingredient. In addition, the large surface area of the peripheral lung helps dilute the therapy, enhancing tolerability. This is a significant advantage over traditional methods, which often have more pronounced side effects. Our approach leverages the body’s natural physiology to improve drug delivery and minimize adverse reactions, setting a new benchmark for safety in inhaled therapies. By focusing on the natural absorption processes, we ensure that our treatments are effective and safe for long-term use, providing a comprehensive solution for patients.
Moe: What are the long-term outcomes for patients using your inhaled therapies for smoking cessation?
While we can’t claim long-term outcomes until our phase three trials are complete, current therapies show only 7% to 10% success rates at six months. Our approach involves a gradual dose reduction, aligning with the natural downregulation of nicotinic receptors in the brain. This method aims to reduce the need for nicotine gradually, potentially leading to better long-term abstinence rates. By synchronizing the reduction of nicotine with the brain’s adaptation, we hope to provide a more sustainable path to quitting smoking, addressing a critical gap in current treatment options. Our goal is not only to help patients quit smoking but also to ensure they remain smoke-free, improving their overall health and quality of life.
Moe: How does Miist address the regulatory challenges of introducing a novel inhalation device therapy?
Regulatory challenges are manageable as the FDA is familiar with inhalation devices. The key is standardizing inhalation to ensure consistent drug delivery. Our software-controlled inhaler automates the process, ensuring patients inhale correctly every time. This automation minimizes variability and enhances the reliability of our clinical trial data, addressing a standard failure mode in inhaled therapies. By leveraging technology to standardize drug delivery, we meet regulatory requirements and improve patient outcomes, demonstrating our commitment to innovation and excellence. Our approach ensures that our therapies are effective and compliant with regulatory standards, paving the way for broader adoption.
Moe: What endpoints are you focusing on in your phase three trials?
Our primary endpoint for phase three smoking cessation study is continuous abstinence during the last four weeks of the study, with secondary endpoints including seven-day point prevalence abstinence throughout the trial. This standard has been used for all nicotine replacement therapies approved in recent decades. By adhering to these established benchmarks, we aim to demonstrate the superior efficacy of our treatments, paving the way for regulatory approval and broader adoption. Our focus on these endpoints ensures that we are meeting regulatory standards and providing meaningful outcomes for patients, improving their chances of long-term success.
Moe: Is there anything else you’d like to add about Miist’s approach or future plans?
Beyond smoking cessation and migraines, our technology is adaptable to other conditions requiring rapid drug delivery to the brain, such as pain and insomnia. The core technology remains the same, allowing us to conduct phase one studies across various therapeutic areas efficiently. This scalability is a significant advantage, enabling us to expand our impact across multiple conditions. By leveraging our platform technology, we are well-positioned to address a critical patient need, instant symptom relief, for many of today’s most common and debilitating conditions.
Moe Alsumidaie is Chief Editor of The Clinical Trial Vanguard. Moe holds decades of experience in the clinical trials industry. Moe also serves as Head of Research at CliniBiz and Chief Data Scientist at Annex Clinical Corporation.
