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Xalud Therapeutics is developing novel, non-opioid therapies for the treatment of neuropathic pain and osteoarthritis. Our lead product, XT-101, has shown exceptional efficacy in the leading rodent models of pain and in canine patients with neuropathic pain and osteoarthritis. XT-101 has an excellent safety profile -- it does not cause sedation, dizziness, numbness, addiction or tolerance.  7 and 28 day GLP toxicology studies have been completed with excellent results.  Xalud intends to file an IND for a Phase I/IIa trial in mid-2015 and, pending funding, initiate clinical trials thereafter.

Xalud's approach to treating pain is fundamentally different than conventional approaches. XT-101 causes the body to produce the natural anti-inflammatory IL-10.  In neuropathic pain, the use of this broad spectrum anti-inflammatory reduces inflammation around the spinal cord and reduces aberant pain signaling.  In gold-standard rodent models, a single injection of XT-101 completely eliminates neuropathic pain for 12 weeks.  We have also tested XT-101 in canine patients with severe osteoarthritis that has been resistant to standard treatments.  In these patients, XT-101 has provided long lasting pain relief resulting in dramatically increased mobility and activity levels and increased joint flexibility.

To date, Xalud's efforts have been supported by over $6 million of grant funding from the NIH, the DOD, and disease foundations.  We seek to raise $6 to $10 Million to fund our initial clinical trial or trials.  These will be placebo controlled Phase I/IIa trials in actual patients.  Because XT-101 has an extended duration, we expect that these trials will provide the safety, efficacy and biomarker data necessary to support a robust Phase II program.

Xeris is a clinical-stage pharmaceutical company developing patient-friendly injectable drugs for various indications with an initial focus on diabetes. The current paradigm for many injectable drugs is to design formulations for delivery in water-based systems.  However, the presence of water is problematic because it actively degrades many molecules often preventing drug products from being packaged for use as a “ready-to-use” solution.  Xeris' patented and patent-pending XeriSol™ and XeriJect™ formulation technologies are transformative in their elimination of water. By replacing water with non-water, bio-compatible carriers already used in other FDA-approved drugs, Xeris solves a number of problems adding significant value to existing injectable drugs and to new drugs in development.  This technology is already being validated with the development of a non-aqueous glucagon formulation that has shown 24 months of room-temperature stability in solution and very positive safety and efficacy in a Phase 2 clinical study. While this product and other glucagon products are being developed and $20M has been raised to support this development, Xeris is seeking to spinoff its earlier stage non-glucagon assets and obtain funding (both equity and non-dilutive) to support these projects.  More specifically, these projects include the development of a non-aqueous, auto-injectable diazepam to replace the current diazepam rectal gel for treatment of epileptic seizures and a non-aqueous, intradermal auto-injectable epinephrine to replace the current, antiquated EpiPen.