Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development of treatments for addictions. Pulse 2.0 interviewed CEO and board member Cary Claiborne Sr. to learn more about the company.
Cary Claiborne’s Background
What is Cary Claiborne’s background? Claiborne said:
“I began my career at GE, concurrently working on an MBA from Villanova University. I worked my way up through the ranks, starting in GE’s Financial Management Program and eventually reaching the position of President of New Enterprise Wholesale Services. I subsequently held many positions across different industries, including Home Depot and MCI.”
“After spending 20 years working outside of healthcare, I realized my passion was working with companies devoted to developing therapies to reach the unmet needs of patients. I have since served in leadership positions in biotech and biopharma companies, including Osiris Therapeutics, Sucampo Pharmaceuticals, and Indivior. As CFO of Indivior, I focused my work on making an impact on patients suffering from addiction. This passion led to my joining Adial Pharmaceuticals as a board member in 2021, as COO in late 2021, and now as CEO as of August 2022.”
Formation Of Adial
How did the idea for the company come together? Claiborne shared:
“The founders of Adial recognized that there was a critical need to develop effective treatments for the millions of people who are suffering from alcohol use disorder and struggling to find a treatment that meets them where they are on their journey to recovery.”
“We took the time to rigorously evaluate the scientific literature and developed a strategy that made sense based on the underlying science. Our strategy is focused on targeting serotonin signaling to disrupt the underlying circuitry involved with alcohol addiction. We also took the time to evaluate current trends and research in addiction treatment, specifically the role of harm reduction in helping people on their path to recovery. This led us to the idea of doing something bold, which was to develop a non-abstinence-based therapy for treating alcohol use disorder.”
Favorite Memory
What has been your favorite memory working for the company so far? Claiborne reflected:
“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.”
Core Products
What are the company’s core products and features? Claiborne explained:
“Our lead asset is AD04, a genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder. This is a unique mechanism compared to existing treatments for Alcohol Use Disorder, which we believe could be complementary to existing interventions. We have identified specific genetic populations which stand to gain the greatest benefit and are now developing a companion diagnostic assay to identify these individuals.”
Challenges Faced
What challenges have Claiborne and the team faced in building the company? Claiborne acknowledged:
“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 surrounding addiction also remains a significant barrier. Addiction is often misunderstood and viewed as a personal failure rather than as a complex medical condition that requires treatment. To combat this, we have prioritized education and advocacy as key components of our strategy.”
Evolution Of Adial’s Technology
How has the company’s technology evolved since launching? Claiborne noted:
“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.”
Significant Milestones
What have been some of the company’s most significant milestones? Claiborne cited:
“Based on the robust data generated from our Phase 2b and 3 clinical trials, we were able to engage in a highly productive meeting with the FDA. During this meeting, we received favorable feedback on both our existing data and our proposed future plans. This invaluable input from the FDA enabled us to develop a comprehensive regulatory strategy for our next steps. These discussions with the FDA were a significant milestone for our company, providing not only a clear path forward but also a crucial alignment in our company’s focus and objectives. This alignment will help us navigate the regulatory landscape more effectively and advance AD04 with confidence.”
Differentiation From The Competition
What differentiates the company from its competition? Claiborne affirmed:
“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 decision to engage with a non-abstinence-based strategy for addiction treatment is rooted in the principle of harm reduction, which has emerged from established research within the field. Unlike traditional approaches that demand complete abstinence, our method acknowledges the complexity of addiction and the varied paths to recovery. By focusing on reducing harmful behaviors and improving quality of life, we offer a more compassionate and realistic alternative for individuals who may struggle with the rigidity of abstinence-only programs. This approach is particularly beneficial for patients who are not ready or able to commit to total abstinence but are motivated to reduce their substance use and its negative impacts.”
Future Company Goals
What are some of the company’s future company goals? Claiborne concluded:
“In the near term, our biggest goal is the initiation of our planned Phase 3 clinical trial for AD04. This milestone is crucial as it will allow us to obtain the necessary data to demonstrate the safety and efficacy of AD04 in treating alcohol use disorder.”
“Ultimately, our mission is to bring a successful therapeutic into the hands of those who need it most, offering hope in the treatment of alcohol use disorder. We are not only advancing the development of AD04 but also laying the groundwork for its potential to transform the landscape of addiction treatment.”
