Xalud Therapeutics proposes to evaluate the applicability of its novel and potent anti-inflammatory therapy, XT-101, for the treatment of motor impairment, gait disorders, and neuropathic pain in degenerative and inflammatory autoimmune rodent models of multiple sclerosis (MS). XT-101 is a non-viral form of gene therapy that causes the meningeal cells surrounding the spinal cord to secrete the powerful, natural, anti- inflammatory interleukin-10 (IL-10). Based on extensive pre-clinical research, Xalud believes that the secreted IL-10 will reduce inflammation and normalize the pathological microglia and astrocyte activity that is seen in MS. Xalud proposes to study XT-101 in both inflammatory and neurodegenerative rodent models of MS and to conduct various cell and tissue analyses to better understand and elucidate the biological effects of XT-101. Xalud expects to demonstrate in these models that XT-101 reduces motor impairment, alleviates gait disorders and resolves neuropathic pain. Xalud also expects that XT-101 will have a positive effect on numerous elements of MS pathology including: immune cell infiltration, inflammation, reduced glutamate transport, demyelination, and neuronal apoptosis. Support of the proposed studies would greatly accelerate the development of XT-101 for clinical applications. Xalud is currently conducting IND-enabling toxicology studies for the use of XT-101 in neuropathic pain and expects to file an IND in late 2013. The additional efficacy data provided by the proposed studies would support the initiation of human trials of XT-101 in neuropathic pain, gait disorders and possibly other MS-related indications. Xalud believes that XT-101, if successfully developed, could have a tremendous impact on the clinical treatment of MS and greatly improve the quality of life MS patients. Neuropathic pain and gait disorders impact almost all MS patients and greatly reduce their ability to participate in society and enjoy life. Further, XT-101 may slow disease progression in the currently untreatable progressive forms of MS. Because the method of action of XT-101 is markedly different from all existing or imminent MS treatments, it has the potential to be an extremely useful addition and complement to current medical practice.

Public Health Relevance

Xalud Therapeutics, Inc. is seeking support to advance the development of XT-101 for the treatment of motor impairment, gait disorders and neuropathic pain associated with multiple sclerosis (MS). Currently, there are no treatments approved for MS-related neuropathic pain or for treating progressive forms of the disease and only one treatment approved for gait disorders. By addressing these areas of tremendous unmet clinical need, Xalud believes XT-101 can greatly improve the quality of life of MS patients.

Agency
National Institute of Health (NIH)
Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
5R43NS081878-02
Application #
8616820
Study Section
Special Emphasis Panel (ZRG1-ETTN-P (11))
Program Officer
Fertig, Stephanie
Project Start
2013-02-15
Project End
2015-01-31
Budget Start
2014-02-01
Budget End
2015-01-31
Support Year
2
Fiscal Year
2014
Total Cost
$350,000
Indirect Cost
Name
Xalud Therapeutics, Inc.
Department
Type
DUNS #
831513770
City
San Francisco
State
CA
Country
United States
Zip Code
94110