KeifeRx is an emerging clinical-stage biotechnology company developing a pipeline of optimized, low dose, orally delivered tyrosine kinase inhibitors (TKIs) for the treatment of multiple, high-need neurodegenerative diseases.
We are a passionate and innovative life sciences company with a mission to develop new effective therapies for neurodegenerative diseases that transcend symptomatic management for Parkinson’s Disease, Alzheimer’s Disease, Lewy Body Dementia, Huntington’s Disease and other neurodegenerative disorders that involve motor, cognitive, behavioral and autonomic symptoms.
KeifeRx’s clinical pipeline is led by Nilotinib BE, an optimized, lower dose formulation of nilotinib delivered as an oral capsule, which the company is advancing in a multicenter Phase 3 clinical trial in early Alzheimer’s disease (NILEAD).
Our portfolio of optimized tyrosine kinase inhibitors (TKIs) are designed to penetrate the brain, induce autophagy, and treat neurodegenerative diseases through the bulk disposal of disease-causing toxic proteins. This approach offers the potential to significantly improve upon current neurodegenerative disease treatments, which are primarily palliative and offer minimal benefits due to their inability to adequately eliminate the toxic proteins that are the root of these deadly diseases.
TKIs are known to inhibit specific receptors such as discoidin domain receptor (DDR)-1, SRC/ABL and KIT to trigger autophagy, thus reducing toxic proteins and eliminating inflammation in the brain. Compelling preclinical and clinical research conducted at Georgetown University by KeifeRx’s co-founder, Charbel Moussa, MBBS, Ph.D., has demonstrated the ability of TKIs to enable protein clearance and eliminate the inflammatory response. This includes published research showing that Nilotinib activates intracellular degradation of amyloid and tau- versus other drugs that only target a single molecule.
KeifeRx’s clinical pipeline is led by Nilotinib BE, an optimized, lower dose formulation of nilotinib delivered as an oral capsule, which the company is advancing in a multicenter Phase 3 clinical trial in early Alzheimer’s disease (NILEAD). KeifeRx has also completed clinical trials of Nilotinib in Parkinson’s disease (Phase 2) and is currently conducting clinical trials in Lewy body dementia (Phase 2) and Huntington’s disease (Phase 1b) through Georgetown University.
In addition to Nilotinib, KeifeRx’s TKI portfolio includes an optimized oral dose of Bosutinib, which is the subject of a Phase 2 clinical program in Lewy Body Dementia. KeifeRx is also advancing an internally-developed TKI – Gutinib – which are currently undergoing optimizing and IND enabling studies involving four separate formulations with patent life through 2037.
Parkinson’s disease is a chronic, progressive ailment caused by neurodegeneration and a decreased concentration of dopamine in the brain, which ultimately leads to the brain’s inability to control body movements. Symptoms include tremor, rigidity, extreme slowness of movement, and impaired balance. Swallowing and speaking difficulties are also common, as are several non-motor symptoms that seriously affect quality of life.
Alzheimer’s disease is a progressive neurodegenerative disease that is characterized by impaired memory and thinking (dementia), and functional decline. With a rapidly accelerating worldwide prevalence, there is a growing societal pressure for curative treatment for Alzheimer’s patients. The burden of Alzheimer’s encompasses clinical burden to patients as well as economic burden to payers and patients and caregiver burden, adding to the urgent need for improved Alzheimer’s therapy. Alzheimer’s is the only top-ten leading cause of death with no known treatment to cure or even slow the progression of disease.
Lewy Body Dementia, also known as dementia with Lewy bodies, is the second most common type of progressive dementia after Alzheimer's disease. Because Lewy body dementia can closely resemble other more commonly known diseases like Alzheimer’s and Parkinson’s, it is currently widely under-diagnosed. Many doctors or other medical professionals still are not familiar with Lewy Body Dementia. Lewy body dementia causes a progressive decline in mental abilities. People with Lewy body dementia may experience visual hallucinations and changes in alertness and attention. Other effects include Parkinson's disease-like signs and symptoms such as rigid muscles, slow movement and tremors.
Huntington’s disease is a fatal genetic disorder that causes the progressive breakdown of nerve cells in the brain. It deteriorates a person’s physical and mental abilities usually during their prime working years and has no cure. Huntington's disease is known as the quintessential family disease because every child of a parent with HD has a 50/50 chance of inheriting the faulty gene. Today, there are approximately 30,000 symptomatic Americans and more than 200,000 at-risk of inheriting the disease. The symptoms of Huntington's disease are described as having ALS, Parkinson’s and Alzheimer’s – simultaneously. Symptoms usually appear between the ages of 30 to 50 and worsen over a 10 to 25-year period. Ultimately, the weakened individual succumbs to pneumonia, heart failure or other complications.
We are an experienced team with deep expertise in neurodegenerative disorders and successful track records in drug repurposing and development.
