GLX1112 is a new oral drug formulation being developed by Glialogix to potentially treat progressive forms of multiple sclerosis (MS), a disease form with very limited treatments to date. An interesting feature of this drug is that it is a proprietary reformulation of an existing and U.S. Food and Drug Administration (FDA)-approved drug, which, the company says (without identifying the drug), has been used for more than 50 years to treat non-neurological conditions at a higher and more chronic dosage. The original drug, however, has poor bioavailability, limiting its entry into the blood-brain barrier, and is associated with gastrointestinal toxicity, all shortcomings the reformulation is expected to address.
GLX1112 Development and Preclinical Testing
The mode of action of GLX112 is neuroprotection, rather than immunomodulation and treatment of disease symptoms. The drug is intended to protect the nerve fibres from damage, and possibly reverses damage, so as to slow or completely inhibit progression.
Glialogix reports that the active pharmaceutical ingredient of GLX1112 has already been tested for efficacy, tolerance, and safety in a Phase 2 trial in MS patients, where it also showed a significant effect in people with progressive MS. Its full efficacy might not be known, however, 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 in the central nervous system. Animal models have shown that GLX1112 improved the bioavailability of its parent drug three-fold, and preclinical tests in multiple MS models are reported to have demonstrated the new drug’s ability to prevent demyelination and decrease the neuroinflammatory cell populations.
What’s Next for GLX1112
The company 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, in September 2014. Research supported under the agreement included advanced pharmacokinetic testing, preclinical models, and further mechanistic studies. Clinical testing of GLX1112, at present, has not begun.
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