Vallon (VLON) Plummets as ADAIR Study Misses Primary Goal

Shares of clinical-stage biopharmaceutical company, Vallon Pharmaceuticals, Inc. VLON, plunged significantly after the company announced that its pivotal SEAL study evaluating ADAIR failed to achieve its main goal.

Vallon’s lead investigational product candidate, ADAIR, is a novel abuse-deterrent formulation of amphetamine immediate release being developed for the treatment of ADHD and narcolepsy.

The SEAL study (Study to Evaluate the Abuse Liability, Pharmacokinetics, Safety and Tolerability of an Abuse-Deterrent d-Amphetamine Sulfate Immediate Release Formulation), is an intranasal human abuse liability study assessing the pharmacodynamics (PD), pharmacokinetics (PK), safety and tolerability of snorting professional laboratory-manipulated ADAIR 30 mg when compared to crushed d-amphetamine sulfate and placebo in recreational drug users. 

Around 55 subjects were enrolled, of whom 53 completed the study and 52 were included in the final analysis.  The study involved a four-way crossover design to evaluate professionally manipulated, intranasal ADAIR 30 mg, crushed intranasal dextroamphetamine, ADAIR 30 mg taken orally, and placebo.

The study did not meet its primary endpoint. ADAIR scored similarly to what was observed in an earlier proof-of-concept study. However, reference dextroamphetamine did not score as high as expected and as seen in the previous study, thus driving the lack of statistical significance.

On a positive note, all pharmacodynamic secondary endpoints met with statistical significance.

The company announced that the pharmacokinetic results and results of other exploratory endpoints along with additional calculation and analysis of other endpoints will be discussed with its partner.

As a result of this plunge, shares of the company have plummeted 61.5% in the year so far compared with the industry’s decline of 12.6%.

Image Source: Zacks Investment Research

The news was disappointing as ADAIR is VLON’s lead candidate.

Apart from ADAIR, the company completed formulation development work and selected the final formulation of its second product candidate, ADMIR, an abuse-deterrent formulation of methylphenidate (Ritalin), for the treatment of ADHD.

Preparations are underway to submit an Investigational New Drug Application (IND) for ADMIR with plans to commence the first human clinical trial in 2022. Per the company, Ritalin is another commonly prescribed stimulant for treating ADHD that is frequently misused and abused.

Vallon has entered into an agreement with Catalent, a leading global provider of advanced delivery technologies, development and manufacturing, to support the development and manufacturing of ADMIR.

Zacks Rank & Stocks to Consider

Vallon currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Vertex Pharmaceuticals VRTX, Voyager Therapeutics VYGR and Kaleido Biosciences KLDO. All three carry a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

The consensus estimate for Vertex’s 2022 earnings has increased $1.13 over the past 60 days to $14.52. Shares of VRTX have gained 13.9% in the year so far.

Loss estimates for VYGR have narrowed to $1.35 from $2.20 for 2022 in the past 60 days. Earnings of Voyager surpassed estimates in three of the trailing four quarters and missed the same once.

Loss estimates for KLDO have narrowed to $1.64 from $2.13 for 2022 in the past 60 days. Earnings of Kaleido Biosciences surpassed estimates in three of the trailing four quarters and missed the same once.


 

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