GLX1112 is an investigative oral therapy being developed by Glialogix for progressive forms of multiple sclerosis (MS). The drug is reported to be a proprietary reformulation of an existing and U.S. Food and Drug Administration (FDA)-approved drug, one not identified by the company but which, it also claims, has been used for more than 50 years to treat non-neurological conditions. The original medicine has poor bioavailability, limiting its passage through the blood-brain barrier, and is also associated with gastrointestinal toxicity, all shortcomings the reformulation is expected to address.
How GLX1112 works
MS is characterized by damage to the myelin sheath, the protective layer that surrounds and insulates nerve fibers. Because of myelin damage, nerves can no longer send messages effectively.
GLX1112 is a sulfasalazine compound. Sulfasalazine is used as an anti-inflammatory agent to treat conditions such as inflammatory bowel disease (IBD) and rheumatoid arthritis. The effectiveness of sulfasalazine as an MS treatment of MS.
The mode of action of GLX1112 in MS is neuroprotection, rather than immunomodulation and the treatment of disease symptoms. In other words, the drug is intended to protect nerve fibers from damage and to help restore nerve function, by promoting remyelination, so as to slow progression of the disease.
GLX1112 development and preclinical testing
A clinical trial, conducted by the Mayo Clinic in 1998 in patients with relapsing and progressive multiple sclerosis, found that sulfasalazine failed to slow disability progression (as measured by EDSS), the trial’s primary goal. But data suggested that treatment had benefits in secondary measures for MS patients, but these benefits were not sustained beyond 18 months.
Preclinical research published in the scientific journal Molecules and Cells in 2015 showed that sulfasalazine has the potential to promote remyelination, or the production of new myelin, to replace what has been damaged in a zebrafish model of MS.
Glialogix reports that the active pharmaceutical ingredient of GLX1112 has already been tested for efficacy, tolerance, and safety in progressive MS patients, and has shown promising clinical results. However, its full efficacy might not have been reached because the company believes dosing in that trial was suboptimal. As an optimized formulation, GLX1112 is expected to address previous drug limitations and enable its safer use for the treatment of MS.
In September 2014, Glialogix entered into a Sponsored Research Agreement with Fast Forward, a nonprofit arm of the National Multiple Sclerosis Society working to accelerate the development of new MS treatments. Research supported under the agreement included advanced pharmacokinetic testing, preclinical models, and further mechanistic studies with GLX1112.