AesRx’s second development program is Aes-210. The Company believes Aes-210 has the potential to treat a number of inflammatory diseases of the lower bowel:

Distal Ulcerative Colitis
Ulcerative colitis (UC) is a chronic form of inflammatory bowel disease characterized by inflammation of the lining of the colon. The specific cause(s) of the disease remain unknown. Inflammation in patients with UC begins in the rectum and extends in a continuous fashion to involve up to the entire lower digestive tract. The rectum and sigmoid colon (i.e., the lower or “distal” parts of the colon) are typically more affected than other regions in adult patients. Ulcerative colitis in the lower portion of the colon is commonly referred to as distal ulcerative colitis (DUC). AesRx believes the anti-inflammatory properties of Aes-210 could be effective in the treatment of UC irrespective of its location. Because Aes-210 is delivered in enema formulation, however, only the distal regions of the colon will be accessible to treatment by this drug candidate. Therefore, in its present dosing format, the benefits of Aes-210 are likely to be available only to patients with DUC. Patients with DUC are at an increased risk of developing colon cancer and serial colonoscopic evaluations with biopsies are recommended to detect dysplasia, a change in the mucosa that implies an increased probability of developing a subsequent malignancy. Patients with DUC are also at risk for development of liver diseases, including sclerosing cholangitis and bile duct carcinoma.

Pouchitis
Colectomy (i.e., removal of all or a part of the colon) with creation of an ileal pouch through the ileal pouch-anal anastomosis (IPAA) has become the surgical treatment of choice for the management of pediatric and adult patients with UC that has proven resistant to existing medical therapies. The development of inflammation in these newly created ileal reservoirs, a condition known as pouchitis, is the most common long-term complication of this procedure and can affect 50-60 percent of IPAA patients. Patients with acute or active pouchitis present with a variety of symptoms, including diarrhea that may also be accompanied by incontinence, rectal bleeding, and fever. Pouchitis most often first occurs during the two years following completion of an IPAA, but can be a chronic problem in up to 20 percent of patients. Pouchitis is an orphan indication. Aes-210 has already been granted Orphan Drug Status by the FDA.

Radiation Proctitis
Of the 8 million to 9 million cancer survivors currently living in the US, approximately 25 percent have undergone or will undergo radiation therapy. During abdominal and pelvic radiation therapy, the intestine is often exposed to radiation-induced toxicity that can lead to inflammation of the mucosal lining of the rectum. This inflammation of the rectal mucosa is known as radiation proctitis. Radiation proctitis is difficult to manage and adversely impacts the long-term quality of life of cancer survivors. Radiation injury to the rectal wall eventually causes connective tissue fibrosis and obliterative endarteritis with subsequent local tissue ischemia. Symptoms of radiation proctitis can persist after radiation treatment has been competed and the disease can progress to chronic bleeding and/or stricture and fistula formation, and ultimately surgical intervention.

The table below shows what AesRx estimates to be the sizes of the potential Aes-210 markets.

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