InflammX Clinical Strategy

 Intermediate age realated macular degeneration

  • iAMD is the precursor to Geographic Atrophy (GA) at which point there is significant vision loss

  • The goal of treating iAMD patients with Xiflam™ at this early stage, is to prevent patients from progressing to severe vision loss and blindness.

  • InflammX is the first company with an FDA accepted Phase 2B trial design and endpoint for iAMD.

  • A 300 patient Phase 2B Clinical Trial with Xiflam™ will be conducted with solely US based sites.

  • Xiflam™ is supported by a clinical safety database of >2000 patients

  • Oral administration significantly increases the provider database (to general ophthalmologists etc.) since the current state of intra ocular injections remains overwhelmingly the domain of retinal specialists.

  • Expanding the provider database ensures a significant expansion of care for this unmet need and a significant shift in health equity for this blinding disease.

Diabetic Eye Disease

• Xiflam™ is currently in an active Clinical Trial evaluating the effect of bilateral oral treatment on Diabetic Macular Edema.

• The Diabetic Clinical Trial is being funded and run by the Diabetic Retinopathy Clinical Research Network, the ophthalmic clinical retinal arm of the NIH. Additional funding has been provided by Breakthrough T1D (formerly Juvenile Diabetic Research Foundation or JDRF) and as such biomarkers related to Diabetic Kidney Disease are being measured from baseline in the clinical trial.

• Treating patients at an earlier stage of the disease with an oral drug that treats both eyes simultaneously is another significant unmet need.

• The goal for earlier treatment is to intervene prior to patients losing significant vision.