Why Adial is developing a pill for alcohol addiction: 'Abstinence is not the only road to recovery’

BPR: What is Alcohol Use Disorder (AUD) and why is it a major health, social and financial problem?​

Alcohol Use Disorder (AUD) is a chronic disease characterized by an individual regularly consuming a quantity of alcohol which is harmful to them both physically and socioeconomically. It is believed that there are over 200 physical and mental health problems associated with AUD, including multiple types of cancer, liver disease, depression, domestic violence, and memory problems.

It is estimated that AUD costs the US healthcare system over $10 billion annually, not taking into account the economic costs of decreased productivity of those suffering from AUD. An estimated 140,000 people die every year in the U.S. from alcohol-related causes, and alcohol use is estimated to play a factor in one-third of all driving fatalities and one-fourth of all deaths by suicide.

AUD can also have significantly detrimental effects on families and communities. More than 10% of children in the U.S. are estimated to live with a parent who has AUD, and substance misuse is involved in between 40-60% of reported incidents of domestic violence.

BPR: What does the current treatment landscape for AUD look like?​

The current treatment landscape for alcohol use disorder (AUD) includes a variety of medications and behavioral therapies. Medications can help to reduce cravings for alcohol, block the intoxicating effects of alcohol, or cause unpleasant side effects if alcohol is consumed. Behavioral therapies can help people to develop coping skills, identify and avoid triggers, and change their drinking habits.

AUD treatments can be quite extreme, requiring patients to make significant alterations to their lives, oftentimes needing to cut out friends and family in order to create an environment where they can commit to fully abstaining from alcohol. Many AUD patients will only enter treatment programs such as Alcoholics Anonymous when they’ve hit 'rock bottom', which motivates them to pursue more severe treatment options.

Current pharmacological approaches can be similarly extreme, causing adverse reactions to alcohol consumption that can be fatal or requiring painful monthly injections via an 18-gauge needle. Despite their availability, the extreme requirements of these treatments prevent many patients from accessing treatment.

BPR: How is Adial’s approach to treating AUD different than the current methods?​

While most AUD treatments require patients to abstain entirely from alcohol, we believe in a non-abstinence-based approach. AD04, the therapy we are developing to treat AUD, can be taken while patients are engaged in non-abstinence-based treatment. AD04 has been shown in clinical trials to reduce alcohol cravings and allow patients to consume alcohol at more moderate levels.

Allowing for a non-abstinence-based approach gives patients more control over their recovery, enabling them to choose the method they think best for them and increasing their buy-in to the program they are following. Non-abstinence-based approaches allow patients to recover from AUD in situ rather than removing them from the stressors and situations they encounter every day, giving them the tools, they need to continue their recovery without interrupting their lives.

BPR: AD04, your lead product, is a genetically targeted therapeutic agent for the treatment of Alcohol Used Disorder. Can you tell us how it works?​

Studies have shown AUD to have a strong genetic component. AD04 targets patients of a specific genotype that we believe were found to be associated with differential reductions in alcohol consumption severity in response to treatment with AD04. Clinical trials have shown that patients with these genotypes have reduced drinking when compared to patients of other genotypes.

This means that physicians can pre-screen patients to see if AD04 will work for them, making it easier for patients and their doctors to find the right prescription. Using genetic testing can also help destigmatize AUD, emphasizing that patients have the disease due to their genetics rather than because of a moral failing.

BPR: What are the challenges of developing a new therapeutic for AUD and how is Adial addressing them?​

AUD is an incredibly complex disorder; development of new treatments needs to factor in the complex interplay of genetic, psychological, and environmental factors that contribute to the manifestation of this disease. By focusing on genetic markers, we can identify a narrower patient population and focus on perfecting the treatment for them before finding ways to target patients with differing genetic profiles.

In developing a non-abstinence-based therapeutic for AUD, there also needs to be a shift in the mindset in those treating AUD. Abstinence has long been accepted as the standard to initiate treatment, and to maintain recovery, but we are aware that 90% of patients are unable to achieve long-term abstinence. We need to emphasize the idea that abstinence is not the only road to recovery.

BPR: How does Adial Pharmaceuticals envision its treatment fitting into the broader landscape of AUD medicine, and what potential impact do you foresee on individuals and healthcare systems?​

We foresee AD04 as a strong addition to the broader landscape of AUD medicine. It offers a novel and personalized approach to AUD treatment that empowers individuals and improves overall healthcare outcomes.

By introducing an alternative to traditional AUD treatments, we hope to encourage more individuals to seek help and adhere to treatment plans effectively. Personalized therapy aligns with the growing trend of tailored medical interventions, potentially leading to more successful outcomes and reducing the burden on healthcare systems. Moreover, it can help reduce long-term healthcare costs by curbing the frequency of hospitalizations and emergency room visits.

BPR: What trends and advancements can we expect to see in the treatment of AUD in the coming years?​

Over the upcoming years, we predict a series of significant developments in the treatment of AUD that will significantly enhance the accessibility of treatment for those who require it. These advancements will primarily be driven by the growing field of precision medicine, which utilizes genetic and neurobiological markers to craft highly personalized therapeutic strategies. This approach will enable healthcare providers to tailor treatments to individual patients, recognizing that one size does not fit all in the realm of addiction treatment.

Furthermore, a substantial shift is expected in the development of medications aimed at targeting specific brain pathways associated with addiction. This evolution in pharmaceutical interventions will contribute to a broader array of treatment options, potentially reducing the reliance on traditional abstinence-based approaches. These novel therapies hold the potential to transform the landscape of AUD treatment, offering more effective and sustainable solutions that address the complex nature of addiction. We firmly believe that non-abstinence-based therapies represent the future of AUD treatment, bringing hope to those affected by this challenging condition.