Adial Pharmaceuticals is a biopharmaceutical firm in the clinical development phase, dedicated to creating therapies for addiction disorders. In an exclusive interview with Pulse 2.0, CEO and board member Cary Claiborne Sr. shared insights about the company's mission and progress.
Cary Claiborne’s History
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Cary Claiborne has a diverse background that spans various fields. He has experience in both the corporate world and community service, which has shaped his perspective and approach to leadership. Claiborne mentioned that his journey has been influenced by his commitment to making a positive impact in his community and his dedication to professional excellence.
"I started my professional journey at GE while pursuing an MBA from Villanova University. I progressed through various roles, beginning in GE's Financial Management Program and ultimately attaining the role of President of New Enterprise Wholesale Services. After that, I took on numerous positions in diverse sectors, including roles at Home Depot and MCI."
"Having dedicated two decades to non-healthcare industries, I discovered my true passion lay in collaborating with organizations committed to creating therapies that address the unmet needs of patients. Consequently, I have held leadership roles in various biotech and biopharma firms, such as Osiris Therapeutics, Sucampo Pharmaceuticals, and Indivior. During my tenure as CFO at Indivior, I concentrated on initiatives aimed at making a difference for patients grappling with addiction. This commitment inspired my transition to Adial Pharmaceuticals, where I became a board member in 2021, assumed the role of COO later that year, and was appointed CEO in August 2022."
Creation of Adial
What inspired the formation of the company? Claiborne revealed:
"The creators of Adial understood the pressing necessity to create effective solutions for the millions affected by alcohol use disorder, who are searching for treatments that align with their individual paths to recovery."
"We dedicated ourselves to thoroughly reviewing the scientific literature and crafting a strategy grounded in the fundamental science. Our approach centers on targeting serotonin signaling to interfere with the neural pathways associated with alcohol addiction. Additionally, we assessed current trends and research in addiction treatment, particularly the impact of harm reduction in supporting individuals during their recovery journey. This exploration inspired us to pursue an innovative idea: creating a therapy for alcohol use disorder that does not rely on complete abstinence."
Cherished Moment
Claiborne reminisced about a particularly memorable moment during their time with the company, saying:
“Reviewing the detailed analysis of the Phase 3 ONWARD trial results by each of the four Genotypes that were enrolled in the trial and learning that one of those four Genotypes (AG) significantly outperformed the others in terms of their response to AD04. Then going backwards to even our prior Phase 2 data to confirm that the AG signal wasn’t just some anomaly, and finding the same result was a great memory. What that meant was that there was a clear path forward in future trials if we focused initially on that genotype. The key is developing a plan after you’ve gotten trial results, seeing where the successes are, and then formulating a strategy to move to the next stage. That moment became the foundation for where we are going as a company now.”
Essential Offerings
What are the main products and features of the company? Claiborne elaborated:
“Our primary asset is AD04, a genetically targeted antagonist of the serotonin-3 receptor designed to treat Alcohol Use Disorder. This innovative mechanism sets it apart from current treatment options for Alcohol Use Disorder, and we believe it could work synergistically with existing therapies. We have pinpointed particular genetic groups that are likely to benefit the most from this treatment and are currently working on a companion diagnostic test to help identify these patients.”
Obstacles Encountered
What obstacles has Claiborne and the team encountered while establishing the company? Claiborne admitted:
“Recent economic changes following the peak in biotech funding a few years ago, and subsequent downturn in the years after have posed significant challenges for the industry as a whole. Investors tend to be cautious to deploy capital in uncertain economic times, and biotech companies are inherently risky due to the lengthy and costly process of bringing a new therapy to market. To overcome this challenge, we have had to be innovative in our approach to fundraising. We also took this opportunity to focus on demonstrating the robustness of our scientific data and recently published several peer-reviewed studies highlighting the safety and utility of our approach.”
"The stigma associated with addiction continues to pose a major obstacle. Many people misinterpret addiction as a personal shortcoming instead of recognizing it as a multifaceted medical issue that necessitates professional care. In response to this challenge, we have emphasized the importance of education and advocacy within our overall approach."
The Progression of Adial's Technology
How has the company’s technology progressed since its inception? Claiborne mentioned:
“As we’ve gained a more comprehensive understanding of the complex nature of addiction, we’ve managed to narrow our focus down to specific genotypes that respond more positively to our therapy. Not everyone responds the same way to certain medications, so we have really focused on pinpointing a subset of patients with alcohol use disorder in whom AD04 is predicted to elicit a particularly robust response and are now using a genetic diagnostic assay to detect these individuals on a genetic basis.”
Notable Achievements
What are some of the most notable milestones achieved by the company? Claiborne mentioned:
“Drawing from the solid data obtained in our Phase 2b and 3 clinical trials, we successfully conducted a fruitful meeting with the FDA. In this discussion, we were pleased to receive positive feedback regarding our current data as well as our strategic plans for the future. The insights provided by the FDA were instrumental in shaping a thorough regulatory strategy for our next actions. These conversations marked an important milestone for our organization, offering not just a clear direction ahead, but also a vital synchronization of our company’s goals and priorities. This alignment will empower us to maneuver through the regulatory environment with greater efficiency and propel AD04 forward with assurance.”
Standing Out From The Competition
What sets the company apart from its competitors? Claiborne stated:
“What sets us apart from others in the Alcohol Use Disorder treatment space is the use of personalized medicine and our non-abstinence-based approach. By using precision medicine to identify the patients most likely to benefit from our therapy, we believe we are placing ourselves on the razor’s edge of scientific advancements in modern medicine. Addiction is a complicated disorder with lots of different causal factors, and everyone’s path to recovery is different. By focusing on a specific population of patients and giving them a pharmacological therapy that offers a flexible path to recovery, we believe we are really doing something groundbreaking compared to what has long been the status quo.”
"Our choice to adopt a non-abstinence-based approach to addiction treatment is founded on the principle of harm reduction, which is supported by extensive research in the field. In contrast to conventional methods that require total abstinence, our strategy recognizes the intricate nature of addiction and the diverse journeys toward recovery. By concentrating on minimizing harmful behaviors and enhancing overall well-being, we provide a more empathetic and pragmatic option for individuals who find the strictness of abstinence-only programs challenging. This approach is especially advantageous for patients who may not be prepared or able to fully abstain but are eager to decrease their substance use and mitigate its adverse effects."
Aspirations for Our Company’s Future
What are some of the company's future objectives? Claiborne summarized:
“Our immediate objective is to launch our scheduled Phase 3 clinical trial for AD04. Achieving this milestone is vital, as it will enable us to gather the essential data needed to prove the safety and effectiveness of AD04 in addressing alcohol use disorder.”
"Our primary goal is to deliver an effective therapy to individuals who need it the most, providing hope for those battling alcohol use disorder. While we are making progress in developing AD04, we are also establishing a foundation for its ability to revolutionize addiction treatment."
