{"id":52121,"date":"2022-12-19T15:02:16","date_gmt":"2022-12-19T14:02:16","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/curasen-therapeutics-announces-successful-completion-of-phase-2-safety-tolerability-and-proof-of-concept-study-in-patients-with-parkinsons-disease-or-mild-cognitive-impairment-mci-with-cst\/"},"modified":"2022-12-19T15:02:16","modified_gmt":"2022-12-19T14:02:16","slug":"curasen-therapeutics-announces-successful-completion-of-phase-2-safety-tolerability-and-proof-of-concept-study-in-patients-with-parkinsons-disease-or-mild-cognitive-impairment-mci-with-cst","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/curasen-therapeutics-announces-successful-completion-of-phase-2-safety-tolerability-and-proof-of-concept-study-in-patients-with-parkinsons-disease-or-mild-cognitive-impairment-mci-with-cst\/","title":{"rendered":"CuraSen Therapeutics Announces Successful Completion of Phase 2 Safety, Tolerability and Proof of Concept Study in Patients with Parkinson\u2019s Disease or Mild Cognitive Impairment (MCI) with CST-103\/CST-107 Treatment"},"content":{"rendered":"
\n

\nUnique Combination of Beta2 Adrenoceptor Agonist (CST-103) and Beta Blocker (CST-107) Eliminated Known Agonist Adverse Events, Establishing Foundation for Longer-Term Clinical Studies<\/i><\/b>\n<\/p>\n

SAN CARLOS, Calif.–(BUSINESS WIRE)–CuraSen Therapeutics, Inc., a clinical-stage company developing small molecule therapies to treat neurodegenerative disease, announced today positive top-line safety, tolerability and proof of concept data, with early efficacy benefit, in a Phase 2 clinical trial with CST-103 in patients with Parkinson\u2019s disease (PD) or mild cognitive impairment (MCI). CST-103 is an oral, brain-permeant beta2 adrenoceptor (\u03b22<\/sub>-AR) agonist that is co-administered with CST-107, a brain-sparing \u03b2-AR blocker, to minimize known cardiometabolic side effects of \u03b22<\/sub>-AR agonists.\n<\/p>\n

<\/a><\/p>\n

\nThe Phase 2 trial was a randomized, double-blinded, two-period crossover study that enrolled 41 patients with neurodegenerative disease. The study evaluated the safety, tolerability and CNS effects of once daily CST-103\/CST-107 treatment, compared to matched placebo, with 14 days treatment on each period and at least 14 days of washout between periods. The majority of patients enrolled had Parkinson\u2019s disease, and specifically a history of REM-sleep behavior disorder (PDRBD<\/sub>). In RBD, people lose their natural paralysis during the dreaming stage of sleep, known as REM sleep, and vigorously act out their dreams with disruptive movements disturbing sleep and safety for themselves and partners. An estimated 30 to 50 percent of all PD patients have a history of RBD; these patients have more rapidly progressing symptoms, especially those involving cognitive and behavioral functions, and greater autonomic dysfunction. The study took place at sites in the UK, Australia, New Zealand and the European Union.\n<\/p>\n

\nResults showed that the combination of CST-103\/CST-107 was both safe and well-tolerated, and importantly, that co-administration of CST-107 eliminated adverse events (AEs) common to the \u03b22<\/sub>-AR agonist class of drugs when administered alone. Such AEs include elevated heart rate, hyperglycemia and hypokalemia, and could otherwise present long-term safety risks in chronic studies of \u03b22<\/sub>-AR agonists. Most AEs observed were mild, and there were no serious or severe adverse events attributed to study drug. Additionally, the study revealed improvements in several quantitative test measures of cognition in patients treated with CST-103\/CST-107, as early as one day after treatment and lasting in some cases for longer than the two weeks of treatment. CuraSen will present complete results from this trial in an oral session at the AD\/PD Conference in Gothenburg, Sweden, March 28-April 1, 2023.\n<\/p>\n

\n\u201cThese data provide strong support for the long-term development of CNS-active \u03b22<\/sub>-AR agonists and validate CuraSen\u2019s unique drug combination approach to treating poorly addressed symptoms in patients with neurodegenerative disease. From a strategic standpoint, we were able to clearly assess the effects of CST-103 on cognitive function and other endpoints without the dose-limiting AEs normally seen with these agonists. Furthermore, the cognitive findings seen in the majority of patients with PDRBD<\/sub> bode well for our plans to launch a larger and longer Phase 2b study in 2023 in this population,\u201d said Anthony Ford, PhD, chief executive officer, CuraSen Therapeutics. \u201cWe look forward to presenting the full results in March, as well as encouraging Phase 1 data from our second neurodegenerative program, CST-2032, in a second oral presentation.\u201d\n<\/p>\n

\nPhase 2 CST-2032\/CST-107 Clinical Trial Ongoing in Parkinson\u2019s and Alzheimer\u2019s Disease Patients<\/b>\n<\/p>\n

\nIn addition to CST-103, CuraSen is conducting a Phase 2 study with CST-2032 in patients with mild cognitive impairment or early dementia from either Parkinson\u2019s or Alzheimer\u2019s disease. As with CST-103, CST-2032 is administered in combination with CST-107 to minimize known side effects of \u03b22<\/sub>-AR agonists. The multi-center trial<\/a>, taking place in the United States and New Zealand, is expected to enroll approximately 60 patients. Following completion of the trial, expected mid-2023, CuraSen plans to initiate longer Phase 2 studies with additional dose levels of CST-2032\/CST-107 in preferred patient populations.\n<\/p>\n

\nAbout Parkinson\u2019s Disease with REM Sleep Behavior Disorder (PDRBD<\/sub>)<\/b>\n<\/p>\n

\nParkinson\u2019s disease (PD) is a degenerative condition of the brain associated with motor symptoms, such as slow movement, tremor, rigidity and imbalance, as well as non-motor complications such as cognitive impairment, depression, sleep disorders, pain and other sensory disturbances, and dysfunction of the autonomic nervous system. PD affects nearly one million Americans and more than eight million people globally, with as many as half of these having a history of RBD. RBD may develop contemporaneously with the typical PD symptoms, but it usually precedes the PD diagnosis by as much as five to 15 years.\n<\/p>\n

\nFocusing on PDRBD<\/sub> has allowed CuraSen to select for PD patients with greater cognitive symptom burden and those likely to respond to the adrenergic stimulation provided by CuraSen\u2019s therapeutic approach. As treatment options for such symptoms are very limited, CuraSen sees great potential in PD to treat these debilitating and progressive non-motor manifestations.\n<\/p>\n

\nAbout Neurodegeneration<\/b>\n<\/p>\n

\nPatients with neurodegeneration experience a loss of neurons in the locus coeruleus (LC) very early in the disease process, decades before functional decline. The LC, known as a key orchestrator of arousal and brain health, delivers most adrenergic input to forebrain structures and activates \u03b22<\/sub>-ARs essential for maintaining mood, memory and cognition, as well as heterocellular support for the brain\u2019s metabolism, perfusion, inflammatory control and clearance of protein debris. When the LC declines, cerebral neuroprotection is undermined by loss of these functions, triggering the pathological hallmarks of neurodegenerative disease and progressive loss of cognitive strength.\n<\/p>\n

\nAbout CuraSen Therapeutics<\/b>\n<\/p>\n

\nCuraSen is focused on the development of new treatments for neurodegenerative diseases, including Parkinson\u2019s disease, Alzheimer\u2019s disease and other related orphan conditions. CuraSen\u2019s drugs are designed to activate certain receptor populations in the brain to compensate for critical neuronal and glial functions that have otherwise been lost due to degeneration and represent a unique approach in the field. The company is evaluating CST-103 and CST-2032, both selective \u03b22<\/sub>-ARs agonists, in combination with CST-107, a \u03b2-AR blocker, in multiple Phase 2 clinical studies. For more information, please visit www.curasen.com<\/a>.\n<\/p>\n

Contacts<\/b> <\/p>\n

\nSusan Kinkead
\n
Kinkead Communications
\n
susan@kinkeadcomm.com<\/a>
415-509-3610\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

Unique Combination of Beta2 Adrenoceptor Agonist (CST-103) and Beta Blocker (CST-107) Eliminated Known Agonist Adverse Events, Establishing Foundation for Longer-Term Clinical Studies SAN CARLOS, Calif.–(BUSINESS WIRE)–CuraSen Therapeutics, Inc., a clinical-stage company developing small molecule therapies to treat neurodegenerative disease, announced today positive top-line safety, tolerability and proof of concept data, with early efficacy benefit, in … [Read more…]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":["entry","post","publish","author-business","post-52121","format-standard","category-industry"],"yoast_head":"\nCuraSen Therapeutics Announces Successful Completion of Phase 2 Safety, Tolerability and Proof of Concept Study in Patients with Parkinson\u2019s Disease or Mild Cognitive Impairment (MCI) with CST-103\/CST-107 Treatment - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/curasen-therapeutics-announces-successful-completion-of-phase-2-safety-tolerability-and-proof-of-concept-study-in-patients-with-parkinsons-disease-or-mild-cognitive-impairment-mci-with-cst\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"CuraSen Therapeutics Announces Successful Completion of Phase 2 Safety, Tolerability and Proof of Concept Study in Patients with Parkinson\u2019s Disease or Mild Cognitive Impairment (MCI) with CST-103\/CST-107 Treatment - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"Unique Combination of Beta2 Adrenoceptor Agonist (CST-103) and Beta Blocker (CST-107) Eliminated Known Agonist Adverse Events, Establishing Foundation for Longer-Term Clinical Studies SAN CARLOS, Calif.–(BUSINESS WIRE)–CuraSen Therapeutics, Inc., a clinical-stage company developing small molecule therapies to treat neurodegenerative disease, announced today positive top-line safety, tolerability and proof of concept data, with early efficacy benefit, in ... 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