Axsome Therapeutics, Inc. announced topline results from the CRESCENDO (Characterizing Patient Perspectives on Unmet Needs in Narcolepsy) survey of patients with narcolepsy type 1 (NT1, i.e., narcolepsy with cataplexy) receiving treatment, demonstrating high rates of persistent symptoms and significant patient burden, despite being on current treatments. CRESCENDO was conducted in partnership with Narcolepsy Network, a national non-profit patient support organization for people with narcolepsy, idiopathic hypersomnia, and related sleep disorders. The CRESCENDO survey included 203 adult patients diagnosed with NT1, who collectively have more than 2,600 years of lived experience with the sleep disorder, to understand their experience and journey, to measure disease symptoms including cognitive impairment while on treatment, and to assess burden of illness, comorbidities, and unmet needs and challenges patients face.

To quantify key elements of the narcolepsy patient experience, CRESCENDO utilized patient reported measures, and validated scales including the Epworth Sleepiness Scale (ESS) to assess excessive daytime sleepiness (EDS), and the British Columbia Cognitive Complaints Inventory (BC-CCI) to assess cognitive function. All patients taking part in the survey were currently undergoing treatment for NT1. The most common treatments were wake promoting agents (about 53% of surveyed patients), oxybates (47%), and stimulants (42%).

Despite receiving treatment, the majority of narcolepsy patients continued to experience symptoms. Cataplexy was reported by 77% of patients while on their current treatment regimen. EDS, assessed using the ESS (scores > 10), was observed in 64% of patients despite receiving current treatments. Cognitive impairment, assessed using the BC-CCI (scores =5), was observed in 74% of patients.

Depression and anxiety were experienced by about 45% and 57% of patients respectively. Axsome plans to present the detailed results of the CRESCENDO survey at upcoming scientific meetings. Key Topline Findings from the CRESCENDO Survey: Patient Demographics: Survey respondents consisted of a total of 203 adults, aged 18-82 years (mean 41 years) with a diagnosis of narcolepsy Type 1, all of whom had experience with FDA-approved treatments for their narcolepsy.

Current Treatments and Comorbidities: Subjects were receiving pharmacotherapy for narcolepsy. The most common narcolepsy-specific treatments were wake promoting agents (53% of surveyed patients), oxybates (47%), and stimulants (42%). 37% of participants were diagnosed with depression, of which 80% were taking medication to manage their depression.

37% of participants were diagnosed with anxiety, of which 72% were taking medication to manage their anxiety. Prevalence of Narcolepsy Symptoms While on Treatment: Cataplexy was reported by 77% of patients while on their current treatment regimen. EDS, assessed using the ESS (scores > 10), was observed in 64% of patients despite receiving current treatments.

Cognitive impairment, assessed using the BC-CCI (scores =5), was observed in 74% of patients on treatment. 68% rated their ability to concentrate as poor, very poor, or average. Cataplexy Impacts on Daily Life: 65% of participants currently experiencing cataplexy reported that cataplexy burdens their professional life (e.g. career, school), despite treatment 60% of participants currently experiencing cataplexy reported that cataplexy burdens their social life, despite treatment.

50% of patients currently experiencing cataplexy reported that cataplexy burdens their day-to-day life, despite treatment 64% and 68% of patients experiencing cataplexy reported being embarrassed by falling down and slurred speech, respectively, despite treatment. Time of Conduct: The survey was conducted between October-December 2023.