SRT001 for Behçet’s Disease
to treat mucocutaneous ulcers

Without a cure, the primary goal of BD treatment is the elimination and management of recurrent ulcers.
  • General agreement amongst rheumatologists that current treatment/management options (i.e., oral & topical steroids, colchicine, azathioprine) are largely ineffective for BD patients. 
  • Systemic therapies are used to try to reduce flare frequency, duration, and severity
  • Access, tolerability, patient-willingness, and AE risk influence systemic therapy choice
  • Mild patients may elect to forgo systemic therapy because of treatment burden or AE rick
  • Episodic systemic prednisone is effective at rapidly reducing BD symptoms; however, they are prescribed sparingly because of SEs
  • Regardless of systemic therapy use, all BD patients are prescribed topical steroids to help control mucocutaneous flares
SRT001 addresses an unmet need for a BD treatment that is both efficacious and able to be used long-term for flares
SRT001 may offer an enhanced treatment option for BD compared to recently approved Otezla
Well defined US FDA and EU EMA pathway to approval

FDA Orphan Designation

FDA Fast-Track Designation

FDA agreement following multiple meetings:

  • Registration may proceed under expedited 505(b)(2) pathway
  • Phase 2/3 registrational trial design may include 80% of BD cases from Turkey (costs in Turkey are 10% of US clinical trials costs)
  • Approved both oral and genital INDs
  • Concurrence on primary clinical endpoints for registration: average daily ulcer number and pain scores
  • EMA Orphan Drug Designation(ODD) application submitted by 1/1/2022. Estimated 6 month to receive ODD.
  • EU Protocol assistance process to begin as soon as the orphan drug designation is awarded and last for about 6mo
  • EU to be included in the same process as FDA NDA submission.
SRT001 FOR APTHOUS ULCERS:  BROAD ORAL HEALTH APPLICATIONS
  • RX TREATMENTS:
  • RECURRENT APTHOUS ULCER SYNDROME
    • HIV/AIDS
    • CANCERS
    • OTHER IMMUNODEFICIENCIES

 
OTC TREATMENT

  • BENIGN SPORATIC ULCERS
  • LARGE POPULATIONS
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