A Phase 2b Study of the Efficacy of a Novel Pro-Neurogenesis/Pro-Plasticity Drug for Bipolar Depression Using a Precision Psychiatry Approach

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Grant Award Details

Grant Number:
CLIN2-15395
Investigator(s):
Name:
Institution:
Type:
PI

Disease Focus:
Human Stem Cell Use:
Award Value:
$15,000,000
Status:
Pre-Active

Grant Application Details

Application Title:

A Phase 2b Study of the Efficacy of a Novel Pro-Neurogenesis/Pro-Plasticity Drug for Bipolar Depression Using a Precision Psychiatry Approach

Public Abstract:
Therapeutic Candidate or Device

ALTO-100

Indication

Bipolar depression (I or II)

Therapeutic Mechanism

ALTO-100 increased hippocampal neurogenesis and neuroplasticity. Its effects are mediated by signaling through the brain derived neurotrophic factor (BDNF) pathway.

Unmet Medical Need

Bipolar depression is a severe, life-long disorder with high burden of illness and risk of suicide. The only approved treatments are antipsychotic medications, which have limited efficacy, are associated with weight gain, metabolic syndrome, movement disorders, and high rates of non-adherence.

Project Objective

Completed Phase 2 trial for efficacy and safety

Major Proposed Activities

  • Enrollment of 200 participants in a Ph 2b trial to assess efficacy of ALTO-100 in adults with BD-D
  • CMC optimization to prepare drug substance and drug product for validation and further scale-up
Statement of Benefit to California:
Given the prevalence of bipolar disorder (1% annual, 4.4% lifetime) introducing a new and effective treatment for bipolar depression will have a major impact on hundreds of thousands of California residents in any given year. This will be seen at the level of the individual patient (improved clinical outcomes, reduction in risk of suicide), health system (decreasing hospitalization-related costs), employer (increasing productivity, presenteeism) and state (reducing medical costs, disability).