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    Takeda Neuroscience at AAN 2021: Data Demonstrates Positive Progress of Key Homegrown Assets, TAK-925 and TAK-935 (soticlestat)

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    Neurological disorders are the leading cause of disability and the second leading cause of death worldwide.1

    At Takeda Neuroscience, we are working to find solutions to alleviate this burden by putting the needs of patients first.

    At the virtual 73rd Annual Meeting of the American Academy of Neurology (AAN) starting on April 17th, 2021, we are presenting data which collectively underscore our commitment to neuroscience and support further investigation of compounds within two of our key development programs: TAK-935 (soticlestat), which is being studied in rare epilepsies and TAK-925, being studied as an orexin agonist which works selectively on orexin 2 receptors, in sleep-wake disorders characterized by excessive daytime sleepiness (EDS).

    “At Takeda Neuroscience, our mission is to develop innovative and potentially disease-modifying medicines for individuals with neurological diseases. To that end, we have intentionally focused our pipeline on a range of conditions that have historically been challenging to address,” said Erika Gill, Vice President Head of Neuroscience Global Product & Launch Strategy. “We are excited to see progress stemming from our pioneering work in orexin therapeutics with TAK-925 as well as with TAK-935 both of which were discovered by Takeda researchers at our labs in Shonan, Japan.”

    Advancing the TAK-935 Clinical Development Program

    Data from three Phase 2 studies that aim to advance the scientific knowledge and understanding of TAK-935, being studied as a selective, oral, inhibitor of the enzyme cholesterol 24-hydroxylase (CH24H), for the potential treatment of rare epilepsies including Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS), will be presented at AAN.2

    • On Saturday, April 17, data from the randomized Phase 2 ELEKTRA study will be presented in an oral session (S1.005; 2:00-3:00PM EDT). This Phase 2 study evaluated the safety, efficacy, and tolerability of TAK-935, an investigational adjunctive therapy in pediatric patients with DS or LGS.
    • Administration of TAK-935 demonstrated a statistically significant median reduction in seizure frequency compared to baseline in the combined DS and LGS patient population during the 12-week maintenance period (30.5% placebo-adjusted reduction; p = 0.0007).3
    • The incidence of treatment emergent adverse events (TEAEs) was similar in both the treatment and placebo groups with 80.3% (n=57) experiencing at least one TEAE compared to 74.3% (n=52), respectively. The most frequently reported TEAEs occurring with a difference of 5% or more over placebo were lethargy and constipation.4
    • Additional data from the TAK-935 program include two poster presentations from the open-label Phase 2 ARCADE study (P7.014) assessing the safety and efficacy of TAK-935 in patients with Duplication 15q syndrome (Dup15q) or Cyclin-Dependent Kinase-Like 5 (CDKL5) deficiency disorder (CDD)5 as well as the long-term Phase 2 open-label extension ENDYMION study (P7.003) which was open to patients who had participated in a previous TAK-935 study, including all patients who completed the ELEKTRA study.6

    In Q1 2021, Takeda secured global rights from Ovid Therapeutics to develop and commercialize TAK-935. Based on the ELEKTRA data, Takeda is meeting with regulatory authorities and intends to initiate Phase 3 studies of TAK-935 in children and young adults with DS or LGS in Q2 2021.

    Building on Early Proof-of-Concept for Orexin Therapeutics in Sleep-Wake Disorders

    We continue to explore the potential of orexin therapeutics across a range of disorders. Data presented at AAN from a Phase 1b study (n=25) in adult patients with Obstructive Sleep Apnea (OSA) who experience excessive daytime sleepiness (EDS) despite adequate CPAP use showed that TAK-925, being investigated as an orexin agonist, demonstrated a statistically significant improvement in mean sleep latency measured by the Maintenance of Wakefulness Test (MWT) versus placebo (placebo, TAK-925 44 mg and TAK-925 112 mg were 12.44, 35.32 and 39.77 min, respectively; p<0.0001 versus placebo).7 Karolinska Sleepiness Scale (KSS) results supported those obtained on the MWT with participants reporting lower sleepiness scores during infusion of TAK-925 than placebo.7,8

    All TEAEs reported were mild to moderate, compared with placebo (TEAEs ≥1 were 21.7% [placebo], 32.0% [TAK-925 44 mg] and 41.7% [TAK-925 112 mg]. Urinary system-related TEAEs were the most common TEAE and appeared to be dose-related. No serious TEAEs or discontinuations due to TEAEs occurred. 7,8

    This data adds to the growing body of evidence evaluating orexin agonists in sleep-wake disorders and supports further investigation in clinical studies, which are ongoing.

    References
    1. Feigin V, Vos T, Nichols E et al. The global burden of neurological disorders: translating evidence into policy. The Lancet Neurology. 2020;19(3):255-265. doi:10.1016/s1474-4422(19)30411-9
    2. A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-935 (OV935) as an Adjunctive Therapy in Pediatric Participants With Developmental and/or Epileptic Encephalopathies (ELEKTRA). ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03650452. Accessed 4/9/2021.
    3. Takeda DoF. TAK-935-3005. April 2021.
    4. Hahn C. Efficacy, Safety and Tolerability of Soticlestat (TAK-935/OV935) as Adjunctive Therapy in Pediatric Patients with Dravet Syndrome and Lennox-Gastaut Syndrome (ELEKTRA). In: 73rd Annual Meeting of the American Academy of Neurology (AAN), 2021. Oral Presentation.
    5. Demarest S. Efficacy, Safety and Tolerability of Soticlestat (TAK-935/OV935) as an Adjunctive Therapy in Patients with 15q Duplication Syndrome (Dup15q) or Cyclin-Dependent Kinase-Like 5 Deficiency Disorder (CDD) in a Signal-Finding Phase 2 Study (ARCADE). In: 73rd Annual Meeting of the American Academy of Neurology (AAN), 2021. Poster Presentation.
    6. Hahn C. Long‐Term Soticlestat Treatment in Patients with Developmental and/or Epileptic Encephalopathies in the ENDYMION Ongoing Open‐Label Extension Study. In: 73rd Annual Meeting of the American Academy of Neurology (AAN), 2021. Poster Presentation.
    7. Takeda DoF. TAK-925-0001. April 2021.
    8. Rubens R. Safety and efficacy of TAK-925 in adults with obstructive sleep apnea who experience excessive daytime sleepiness despite adequate use of CPAP. In: 73rd Annual Meeting of the American Academy of Neurology (AAN), 2021. Poster Presentation.
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