Sovateltide (PMZ-1620), a first-in-class investigational product, shows promise to slow down the progression of Alzheimer's disease in patients
WILLOWBROOK, Ill., June 10, 2021 /PRNewswire/ -- Pharmazz, Inc. a biopharmaceutical company focused on developing and commercializing novel therapeutics to treat patients in critical care. The Company is developing sovateltide for Alzheimer's disease.
Sovateltide, a first-in-class investigational product, shows promise to slow down the progression of Alzheimer's disease
Drugs approved for Alzheimer's disease treatment include the cholinesterase inhibitors donepezil, rivastigmine, and galantamine, and the N-methyl-D-aspartate antagonist memantine. Recently, aducanumab a monoclonal antibody that targets β-amyloid was approved by the US FDA. Although aducanumab improves Clinical Dementia Rating, there is an unmet need for therapies that halt or slow the progression of Alzheimer's disease.
Sovateltide (PMZ-1620) is an endothelin-B receptor agonist shown to significantly improve cellular, molecular and physiological events, e.g., anti-oxidative activity, anti-apoptosis, mitochondrial fusion, and biogenesis, angiogenesis, tissue re-perfusion, neuronal differentiation, tissue regeneration, and repair in the CNS. Sovateltide promotes the differentiation of neuronal progenitors to produce mature neuronal cells after damage to the CNS. In animal models of Alzheimer's disease, sovateltide significantly improved clinical parameters and reduction in β-amyloid plaques in the brain.
Pharmazz, Inc. is conducting a human phase II trial using sovateltide to treat Alzheimer's disease patients (NCT04052737; CTRI/2017/12/016394). This trial is an 80 patients study, an interim analysis of 62 patients (control n=31 and sovateltide n=31) having completed 180 days treatment and follow-up with shows sovateltide can slow down the progression of Alzheimer's disease. A change from baseline in Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-Cog) at 180 days of treatment (day of randomization) was 1.382 ± 0.920 (95% CI -0.702 to 3.466) in the control group and 0.247 ± 0.955 (95% CI -1.918 to 2.412) in the sovateltide group. The baseline ADAS-cog score was 22.59 in the control group and 27.85 in the sovateltide group, indicating that disease severity was more significant in the sovateltide group than in the control group. Mini-mental state examination (MMSE) score changed by 1.226 ± 0.498 (95% CI 0.095 to 2.356) from a baseline of 19.45 in the control group, while it changed by 0.9355 ± 0.5004 (95% CI -0.198 to 2.069) from a baseline of 17.42 in the sovateltide group. Neuropsychiatric Inventory (NPI) score changed by -0.548 ± 1.123 (95% CI -3.093 to 1.996) from a baseline of 9.516 in the control group, whereas the NPI score changed by -1.968 ± 1.077 (95% CI -4.407 to 0.471) from a baseline of 9.871 in the sovateltide group.
The interim analysis of data indicates a numerical difference indicative of a potential beneficial effect of sovateltide in Alzheimer's disease patients with late early to moderate stage disease.
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SOURCE Pharmazz, Inc.