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Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW) is a clinical-stage biopharmaceutical company dedicated to developing therapies for the treatment and prevention of addiction and related disorders. The company leverages its extensive expertise in pharmacology and pharmacogenomics to create personalized treatment options.
Adial’s lead investigational drug, AD04, is a genetically targeted, serotonin-3 receptor antagonist. It is designed to treat Alcohol Use Disorder (AUD) in heavy drinking patients with specific genetic markers, as identified through Adial’s proprietary companion diagnostic genetic test. The ONWARD™ pivotal Phase 3 clinical trial demonstrated promising results in reducing heavy drinking among patients with these target genotypes, with no significant safety or tolerability concerns.
AD04’s therapeutic potential extends beyond AUD. It is believed to be effective in treating other addictive disorders such as Opioid Use Disorder (OUD), gambling, and obesity. Adial is constantly expanding its patent portfolio to cover these broader applications. Recent patents enhance the intellectual property protection around AD04, including its unique ability to target the serotonin transporter gene for treating OUD.
Adial’s innovative approach has garnered regulatory compliance and favorable feedback from both the U.S. and European agencies. The company is in active discussions with potential strategic partners to support the development and commercialization of AD04 internationally. Key patents issued in 2024 further solidify Adial’s market position in treating addiction with a personalized approach.
Financially, Adial has maintained a strong balance sheet, enabling accelerated development of AD04. The company has strategically streamlined its operations, reducing general and administrative expenses significantly in 2023. Recent financial reports indicate positive steps toward achieving regulatory milestones while maintaining a robust pipeline of development activities.
Adial also recently received significant funding from warrant exercises, which will support ongoing clinical and regulatory efforts. The company continues to advance its pharmacokinetics study for AD04, aiming to optimize the study design for upcoming Phase 3 trials under the FDA’s guidance.
Adial is committed to transforming the lives of those affected by addiction through innovative, genetically targeted treatments. With a focus on personalized medicine, the company strives to offer new hope to millions dealing with addiction disorders worldwide. For more information, visit www.adial.com.
Adial Pharmaceuticals (NASDAQ: ADIL; ADILW) announces a conference call on August 20, 2021, at 11:00 A.M. ET for a clinical update and business developments. The call can be accessed via telephone or webcast. The Company focuses on therapies for addiction, with its lead product, AD04, currently in a pivotal Phase 3 trial targeting Alcohol Use Disorder (AUD). Prior Phase 2b results showed significant reductions in drinking frequency and quantity without major safety concerns. AD04 may also address other addictive disorders.
Adial Pharmaceuticals (NASDAQ: ADIL; ADILW) announced recent patent issuances for its lead asset, AD04, aimed at treating Alcohol Use Disorder (AUD) and Opioid Use Disorder (OUD). Patents were granted in the U.S., Canada, Israel, and Brazil, protecting the use of AD04 for patients with specific genetic markers. The ONWARD trial, a Phase 3 study for AD04 in AUD, is ongoing across seven countries. The company highlights the potential of AD04 in treating OUD, given the similarities in addiction physiology. CEO William Stilley emphasizes these advancements as significant opportunities.
Adial Pharmaceuticals (NASDAQ: ADIL; ADILW) announced the completion of a $5,000,002 private placement of 1,666,668 shares at $3.00 each, funding its ONWARD™ Phase 3 trial for AD04, a treatment for Alcohol Use Disorder (AUD). The financing, totaling $7.1 million when combined with a previous round, supports trial completion until data read-out. CEO William Stilley expressed confidence in investor support and business outlook. AD04 aims to target specific genetic profiles in AUD treatment, with prior trials showing significant results without safety concerns.
Adial Pharmaceuticals (NASDAQ: ADIL; ADILW) announced that its CEO, William Stilley, has published an op-ed on Nasdaq.com, discussing the importance of addressing Alcohol Use Disorder (AUD). The op-ed highlights that over 30 million people in the U.S. are affected by AUD, leading to more than 95,000 deaths annually, and a cost of $250 billion to the nation. Stilley underscores the positive impact of their investigational drug AD04, currently in a pivotal Phase 3 trial for AUD. The trial's results from a Phase 2b study showed promising reductions in drinking frequency and no significant safety issues.
Adial Pharmaceuticals (NASDAQ: ADIL; ADILW) announced promising advancements in its adenosine analog development platform via its acquisition of Purnovate. The compounds developed show potency against targeted adenosine receptors while maintaining high solubility, achieving over 50 times more solubility than similar compounds. Initial studies indicate good oral bioavailability and pharmacological activity, particularly in reducing pain in rodents and demonstrating synergy with morphine and acetaminophen. These findings position Adial to potentially replace opioids and address addiction issues.
Adial Pharmaceuticals (NASDAQ: ADIL; ADILW) has entered into Securities Purchase Agreements for a private placement of 1,666,667 shares at $3.00 each, totaling $5 million. Leading the placement is Bespoke Growth Partners, Inc., contributing $2.5 million. The investment will be funded in two tranches: $500,000 immediately and the remaining $4.5 million following share registration. Adial focuses on addiction treatments, with its lead product AD04 currently in a pivotal Phase 3 trial for Alcohol Use Disorder (AUD), showing promising results in earlier trials.
Adial Pharmaceuticals announced key progress in its ONWARD Phase 3 clinical trial for AD04, aimed at treating Alcohol Use Disorder (AUD). The company achieved 100% screening and 90% enrollment targets, with 261 out of 290 expected subjects enrolled. Notably, 33% of screened patients tested positive for the genotype linked to AD04. The medication appears well-tolerated, with no serious adverse events reported. The retention rate stands at 84%, exceeding the projected 70%. Data from the trial is anticipated in Q1 2022.
Adial Pharmaceuticals has been added to the Russell Microcap® Index effective June 28, 2021. This inclusion follows the annual reconstitution of Russell indexes. The CEO stated that this reflects progress in increasing shareholder value, particularly with the clinical development of AD04 for alcohol use disorder through its ONWARD™ Phase 3 trial. Membership may enhance awareness and liquidity among institutional investors, aligning Adial with a vast $10.6 trillion in assets benchmarked against Russell indexes.
Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW) announced the denial of its Fast Track Designation request from the FDA for its drug candidate AD04, aimed at treating Alcohol Use Disorder in pediatric and adult patients with Alcoholic Liver Disease. The FDA cited insufficient evidence of AD04's potential to address unmet medical needs given existing treatments. Despite FDA acknowledgment of the medical need, further data is required for reconsideration. The ongoing ONWARD Phase 3 trial continues to evaluate AD04's efficacy in genetically screened patients across multiple countries.
Adial Pharmaceuticals has announced plans to enter the genetic testing market following a Notice of Allowance from the U.S. Patent and Trademark Office. This patent covers the use of a genetic diagnostic panel in combination with its product AD04 for treating Alcohol Use Disorder (AUD) and potentially Opioid Use Disorder (OUD). The company estimates a multi-billion dollar market opportunity, anticipating that genetic evaluations can help identify patients likely to benefit from AD04. If approved, the patent will provide market exclusivity, enhancing Adial's commercial strategy.
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