Spinogenix Inc, a California-based clinical-stage biopharmaceutical company developing therapeutics that restore synapses, announced on Thursday positive results from the first cohort of its Phase 2a trial in Australia, evaluating SPG302 for the treatment of Alzheimer's disease (AD).

SPG302 is a once-daily pill that, by promoting synaptic regeneration, has the potential to reverse cognitive decline in people with mild to moderate AD.

The randomized, double-blind, placebo-controlled Phase 2 study of SPG302 assessed the safety, tolerability, and clinical efficacy of SPG302. Two dose cohorts completed 24 weeks of treatment (including a 4-week double-blind, placebo-controlled phase and an open label extension period). Clinical cognitive assessments of Mini-Mental State Examination (MMSE) and Clinical Dementia Rating Sum of Boxes (CDR-SB) were measured.

Spinogenix said that results from the first cohort, presented at the recent Alzheimer's Association International Conference (AAIC), demonstrated: SPG302 was safe and well tolerated with no severe or treatment-related adverse events; participants displayed evidence of rapid cognitive benefits, with a nearly 3-point increase in MMSE score within four weeks; cognitive improvement was sustained throughout six months of open-label treatment; participants in the open label extension also achieved durable improvements in CDR-SB between four-to-six months of treatment; and SPG302 as a monotherapy or in combination with standard of care therapeutics was well tolerated by participants.