PK061
PK061
Therapeutic Drug
a proprietary formulation of two existing drugs that may reduce or eliminate toxic aggregates of two proteins -amyloid-β-(αβ) and tau proteins that form deposits in the brain and other endpoints for early & mild stage patients diagnosed with Alzheimer’s disease.
Summary
• Use of patented combination of two drugs (an antidepressant and antipsychotic drug) for the dis-aggregation of toxic oligomeric proteins & other possible symptoms associated with Alzheimer’s disease (AD)
• The drug action is through dis-aggregation of previously formed toxic oligomers of amyloid proteins
• Expansion of a commercial formulation from a patient prospective as a combined single tablet, capsule or suspension aligned to the clinical program.
• Other potential indications include ‘brain fog’ associated with long COVID, post traumatic stress disorder
Status
Commencing Phase 1b/2a clinical trials Q1 2022
Strength
• Seeking a 505(b) clinical pathway from FDA
• Seeking an advancement of Hybrid Scheme clinical pathway under Article 10 directive 2001/83/EC from EMA
• Expansion of formulation and biomarker may bring enhanced clinical outcomes
• Has the potential to become a prophylactic and/or first line of a cost effective treatment against early AD.