Taking a gamble by purchasing the rights to an underperforming narcolepsy drug may soon begin paying dividends for Axsome Therapeutics.
The New York City central nervous system (CNS) specialist has scored in a phase 3 trial testing Sunosi (solriamfetol) on adults with attention deficit hyperactivity disorder (ADHD).
The study achieved its primary and key secondary endpoint as Sunosi, compared to placebo, provided “substantial and statistically significant” improvement in ADHD symptoms and a “statistically significant” reduction in overall ADHD severity.
In 2022, Axsome paid $53 million up front to acquire Sunosi from Jazz Pharmaceuticals, three years after the Ireland drugmaker scored FDA approval to treat patients with narcolepsy and obstructive sleep apnea (OSA).
The companies struck the deal believing Axsome was better equipped to develop the dopamine and norepinephrine reuptake inhibitor (DNRI) for other indications—including major depressive disorder (MDD), binge eating disorder (BED), and excessive sleepiness associated with shift work disorder (SWD).
In the ADHD trial, coded Focus, Axsome tested 516 adults in three treatment arms, with patients receiving placebo or Sunosi in a 150 mg dose or a 300 mg dose for six weeks.
As measured by the Adult ADHD Investigator Symptom Rating Scale (AISRS), Sunosi dosed at 150 mg provided average reductions from baseline of 17.7 points, compared to 14.3 points for placebo. Overall, Sunosi provided a 45% mean reduction from baseline in ADHD symptoms. With clinical response defined as a 30% improvement from baseline, 54% of patients in the 150 mg arm reached the standard compared to 41% of those on placebo.
As for the 300 mg dose of Sunosi, results were numerically superior to placebo, but came up short of statistical significance.
The results square up with those produced by Supernus’ Qelbree, “which showed a similar 3.8-point placebo-normalized reduction in AISRS at Week 6,” William Blair analyst Myles Minter, Ph.D., wrote in a note to investors Tuesday, though he warned of the difficulty in making cross-trial comparisons.
“The symptom improvements observed with solriamfetol were accompanied by a favorable safety and tolerability profile,” Gregory Mattingly, M.D., president of the American Professional Society for ADHD and Related Disorders, said in a release. “Based on these compelling data, solriamfetol has the potential to be an important new treatment option for adult patients living with ADHD.”
Axsome did not address a regulatory filing timeline for Sunosi in the indication. CEO Herriot Tabuteau, M.D., said that the company plans to initiate a trial in pediatric patients this year. Citing FDA guidelines, Minter suggested that Axsome may need to run two separate pediatric trials for both adolescents 13 to 17 years of age and younger kids.
Upon the approval of Sunosi six years ago, Leerink Partners analyst Ami Fadia projected potential sales of $500 million by 2023, given its novel mechanism of action and strong efficacy data to back it up.
But the treatment was never on that trajectory under Jazz, which reported the drug's sales as $58 million in 2021. Sunosi has shown more promise under the wing of Axsome as 2024 sales reached $94 million, which was an increase of 26% from 2023.
Things are happening quickly for Axsome, which Tabuteau founded in 2013. Two months ago, the company gained an FDA approval for migraine treatment Symbravo and saw its market cap surge to $5.3 billion. Axsome has projected Symbravo as a potential blockbuster.
Axsome's first approval came in 2022 for major depressive disorder (MDD) treatment Auvelity, which racked up sales of $291 million last year.
Potentially building on Auvelity, Axsome is also expected to report data for Sunosi as an MDD treatment from the phase 3 Paradigm study in the first quarter. However, as Minter noted, more than one phase 3 trial is needed for an MDD filing with the FDA.
Minter added that the latest ADHD readout “adds to a string of recent wins for the company, including clarity" on a regulatory path to an NDA filing for Alzheimer’s disease treatment AXS-05.
https://www.fiercepharma.com/pharma/axsome-touts-success-phase-3-trial-sunosi-adhd
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