Benzinga | Oct 12, 2021 08:46AM EDT

Vallon Pharma Offers Update On Progress Of Its Development Programs, ADAIR, ADMIR

- Lead program, ADAIR, advancing toward completion of patient enrollment and treatment in ongoing SEAL study

- Selection of final formulation completed for second development program, ADMIR

- Company's two lead programs targeting the large and growing ~$9 billion US ADHD market

- New data from a survey of nearly 500 prescription stimulant abusers support the clinical unmet need for abuse deterrent stimulants

PHILADELPHIA, PA, Oct. 12, 2021 (GLOBE NEWSWIRE) -- Vallon Pharmaceuticals, Inc. (NASDAQ:VLON), ("Vallon" or the "Company"), a clinical-stage biopharmaceutical company primarily focused on the development of novel drugs that are designed to deter abuse in the treatment of central nervous system (CNS) disorders, today provided an update on the progress of its development programs, ADAIR and ADMIR, which leverage the Company's proprietary technology that is designed to resist manipulation for snorting and provide barriers to injection.

"Over the past few months, we have made considerable progress on multiple fronts. While the COVID-19 pandemic has presented some inevitable challenges in patient recruitment for the SEAL study, we are pleased to have achieved approximately 75% of target subject completion. We have implemented additional recruiting initiatives which have bolstered our enrollment efforts. Our team continues to advance toward the completion of enrollment and treatment of all subjects, now targeted for the first quarter of 2022, with topline results expected shortly thereafter," commented David Baker, President & Chief Executive Officer of Vallon.

"Additionally, we have made important advancements in our second development program, ADMIR, by finalizing the selection of a very promising abuse-deterrent formulation of methylphenidate (Ritalin(r)). We have signed a manufacturing agreement with Catalent, a development and manufacturing partner and are moving towards filing an IND which will allow the commencement of human clinical trials. In addition, we've strengthened our corporate expertise and leadership with the formation of a scientific advisory board. We believe their knowledge and expertise will be a significant asset and validates our approach to the advancement our CNS-focused, novel abuse-deterrent platform. With this exciting progress, I believe we are well-positioned to successfully bring our first program, ADAIR, across the finish line and continue to progress additional opportunities in the development of much-needed treatments for CNS disorders," added Mr. Baker.

ADAIR1 Abuse-Deterrent Formulation of Dextroamphetamine

ADAIR is the Company's proprietary abuse-deterrent formulation of immediate-release dextroamphetamine currently in development for the treatment of attention deficit hyperactivity disorder (ADHD) and narcolepsy. ADAIR is being developed leveraging the de-risked 505(b)(2) regulatory pathway and is currently being evaluated in a pivotal intranasal abuse study, the SEAL study. The SEAL study is expected to be the final clinical trial prior to NDA filing. If approved, ADAIR has the potential to address the growing Adderall(r) segment of the ~$9 billion US ADHD market.

The SEAL study is a pivotal randomized, double-blind, double dummy, placebo and active-controlled 4 period, 4-way crossover assessing the pharmacodynamics (PD), pharmacokinetics (PK), safety and tolerability of manipulated ADAIR 30 mg when compared to crushed d-amphetamine sulfate and placebo. Safety will be assessed via adverse events, vital signs, ECGs, clinical laboratory tests and other standard measures.

Patient enrollment is ongoing with approximately 75% of the target number of subjects completing the study. The final patient visit and completion of treatment is expected in the first quarter of 2022 with topline results expected shortly thereafter.

ADAIR is also currently being developed in Europe and the UK through a license and collaboration agreement with MEDICE Arzneimittel P?tter GmbH, a leader in the European ADHD market. The Company is in ongoing partnering discussions for additional regional license opportunities for ADAIR.

Vallon received its first EU patent for ADAIR in July 2021. The Company has filed additional patents in other major territories that are important ADHD markets in order to bolster its IP protection.

ADMIR: Abuse-Deterrent Formulation of Methylphenidate (Ritalin(r))

The Company's second program in development is ADMIR, a novel abuse-deterrent formulation of immediate-release methylphenidate (Ritalin). Ritalin is another commonly prescribed stimulant for treating ADHD that is frequently misused and abused.

Vallon has completed its formulation development work and selected a final formulation for ADMIR. This formulation has demonstrated excellent dissolution and abuse-deterrent characteristics in the laboratory setting that the Company believes is compelling for advanced development. Preparations are underway to submit an IND with plans to commence the first human clinical trial in 2022.

Additionally, the Company recently entered into an agreement with Catalent to support the development and manufacturing of ADMIR. Catalent is a leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable global clinical and commercial product supply.

Real World Stimulant Abuse Insights and the Need for Abuse-Deterrent Formulations

In addition to advancing its clinical programs, the Company recently sponsored a large survey on stimulant abuse patterns in adults. The survey was led by researchers at the University of Kentucky and included nearly 500 people who misuse or abuse prescription stimulants. Results of the survey provided important insights into patterns of abuse and confirmed the clinical unmet need for products with abuse deterrent characteristics like ADAIR. Results from the survey have been accepted for presentation at the upcoming American Academy of Child and Adolescent Psychiatry Annual Meeting being held virtually October 18-30, 2021.