Emtora Biosciences

Commercializing eRapa™,
a novel, targeted formulation of rapamycin



Early Stage Prostate Cancer

Prostate cancer is the most common cancer in men.  Currently ~3M men are living with prostate cancer in the US and prostate cancer deaths exceed 29,000 in the US annually.  Around 165,000 men in the US are diagnosed with prostate cancer each year.  Approximately 80% of newly diagnosed cases are early stage, and men with early stage cancers (Gleason <7) under active surveillance have no effective therapies to slow or prevent cancer progression.  A majority of men elect premature surgical and/or radiation treatment regardless of the disease severity. 90% of treated patients experience erectile dysfunction, impotency, bowel distress, and other side effects.  We postulate that treating early state prostate cancer patients with low doses of eRapa will prevent the progression to prostate cancer.

  • Phase 1b safety and dosing clinical trial underway: three cohorts treated; fourth cohort being treated mid-March 2019; completion by summer 2019.
  • Trial taking place at UT Health San Antonio under the leadership of Principal Investigator Dr. Mike Liss.
  • Safety, dosing, and immunologic response endpoints will be foundational for all future clinical trials.

Familial Adenomatous Polyposis (FAP)

Familial Adenomatous Polyposis is a genetic condition that increases the lifetime risk of colon cancer from ~20% to nearly 100%.  The disease presents as hundreds to thousands of polyps growing in the colon and rectum, usually starting in an individual’s mid-teens.  The polyps are nearly 100% certain to develop into colon or rectal cancer by age 40.  No approved pharmaceutical treatments exist for FAP; the current standard of care is colon and bowel resection to avoid progression to colon cancer.  Approximately 50,000 FAP patients exist in the US; this relatively small patient population designates FAP as a rare disease by the FDA.

While several publications demonstrate promise for rapamycin in gastrointestinal diseases in humans, the high doses required to counteract the acid degradation in the stomach result in many side effects. However, eRapa™ protects the active ingredient from the low pH environment of the stomach, and in pre-clinical studies eRapa™-dosed mice showed impressive disease suppression and life spans 5x greater than untreated mice in a mouse model for FAP.

  • Pilot Phase 2 clinical trial planned for late 2019 
  • Proven effect in pre-clinical mouse model
  • Targeted delivery of the active pharmaceutical ingredient to the lower intestines  
  • Orphan Drug candidate with label expansion opportunities
  • Expedited 505(b)(2) pathway greenlighted by FDA