Glialogix: Fast Track To a New Treatment for Progressive Multiple Sclerosis
Company. Glialogix is a privately held company based in the San Francisco Bay Area. The company was founded by two veterans of the biotechnology industry who have each co-founded other biotech companies. Glialogix has built a board and advisory group composed of experts in the science of multiple sclerosis and neurodegenerative diseases, clinical development, intellectual property and business development.
Mission. To develop GLX1112 as a breakthrough therapy for progressive multiple sclerosis.
Opportunity. Progressive MS is poorly treated and represents a >$3 billion dollar a year market opportunity. The only approved therapy for progressive multiple sclerosis is a chemotherapy drug administered by the intravenous route that has limited efficacy and a lifetime exposure limit, and therefore not used widely.
New Neuroprotective Approach. Glialogix has a novel and unique therapeutic approach to treating progressive MS. Unlike past approaches, which target the peripheral immune system, our approach is neuroprotective and designed to reduce the chronic damage to oligodendrocytes and neurons within the CNS. Glialogix's drug has been shown to prevent demyelination and neuroinflammation, the two key pathologies of Progressive MS.
GLX1112 is Optimistic Based on Existing Clinical Data. Glialogix's drug has already been tested in a double-blind, placebo-controlled Phase 2 trial by a noted group of MS clinical researchers. In this prior clinical trial, a large efficacy signal was detected in progressive MS patients using the Expanded Disability Status Scale (EDSS) - the broadest measure of clinical utility in MS. Glialogix is using the results of the previous clinical trial to optimize the design and dosing regimens of future clinical trials.
Rapid Clinical Development. GLX1112 is an improved proprietary formulation of an existing drug that is FDA-approved for non-neurological indications. Glialogix's formulation is designed to optimize the pharmacokinetic properties of the parent compound and increase the therapeutic index when used for central nervous system indications. Glialogix plans to use the 505(b)(2) regulatory pathway to develop GLX1112. The 505(b)(2) pathway is an innovative regulatory pathway that that is designed to lower costs and speed development times.
External Validation. The promise of our therapeutic approach has been validated by third party experts in multiple sclerosis.
De-risked Approach. Our approach is intended to significantly mitigate the major risks in drug development. By making use of existing clinical data in our patient population, we reduce the leading risk of failure in drug development - lack of clinical efficacy. By reformulating an existing, FDA-approved drug, we also mitigate other leading causes of drug development failure - unexpected toxicology or pharmacokinetics that are incompatible with the patient population. By focusing on progressive MS, we can protect our intellectual property not only through patents but by the statutory market exclusivity that is available to orphan indications.
Additional Therapeutic Opportunities. The target of GLX1112 is involved in a broad range of neurodegenerative diseases, and Glialogix's drug has demonstrated efficacy in pre-clinical models of ALS, neuropathic pain, Alzheimer's disease, epilepsy and ischemic stroke.