CuraSen Therapeutics Announces Successful Completion of Phase 2 Safety, Tolerability and Proof of Concept Study in Patients with Parkinson’s Disease or Mild Cognitive Impairment (MCI) with CST-103/CST-107 Treatment

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

Excerpt from the Press Release:

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’s disease (PD) or mild cognitive impairment (MCI). CST-103 is an oral, brain-permeant beta2 adrenoceptor (β₂-AR) agonist that is co-administered with CST-107, a brain-sparing β-AR blocker, to minimize known cardiometabolic side effects of β₂-AR agonists.

The 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’s disease, and specifically a history of REM-sleep behavior disorder (PD_RBD). 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.

Results 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 β₂-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 β₂-AR agonists.

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