Man suffering from abdominal pains

SGX201 for Radiation Enteritis

Disease Area

Radiation Enteritis

PreclinicalPhase 1Phase 2Phase 3Market
Preclinical
Phase 1
Phase 2
Phase 3
Market

Orphan and/or Fast Track Designation

Denotes funding in whole or in part by NIH, BARDA and/or FDA.

Oral Anti-inflammatory for Acute Radiation Enteritis

Radiation Enteritis is an inflammatory bowel condition resulting from radiation damage to the abdominal and pelvic areas. Acute Radiation Enteritis occurs during or immediately after a radiation treatment course while the chronic disease represents an inadequate healing process in the intestines after radiation damage. SGX201 is an oral, topical anti-inflammatory steroid for the treatment of the gut, which may address both the short-term exacerbation of damage caused by the inflammatory response as well as aiding in re-establishing the normal repair process in the gut over the longer term.

Background on Radiation Enteritis

Radiation enteritis occurs to some degree in almost all patients treated with radiation directed at the abdomen or pelvic area. This includes most patients with cancer of the bladder, uterus, cervix, rectum, prostate, and vagina. The bowel is very sensitive to radiation damage.

Acute radiation enteritis generally occurs around the second week of radiation treatment and includes symptoms of diarrhea, nausea, vomiting, stomach cramps, fecal urgency and loss of appetite.

Chronic radiation enteritis may occur in 20-50% of patients and typically develops between 18 months and 6 years after completion of therapy. Symptoms vary and may include pain after eating, acute or intermittent small bowel obstruction, nausea, loss of appetite, weight loss, bloating, diarrhea, inability to extract nutrients from food eaten and the excretion of fat in feces.

Fibrosis (thickening or scarring) of cells in the gastrointestinal lining is a common feature of chronic radiation enteritis and is believed to be directly related to the initial radiation damage and/or the resulting inflammatory response.

There are over 100,000 patients annually in the US receiving abdominal or pelvic radiation treatment for cancer who are at risk of developing acute and chronic radiation enteritis.

Current Treatments

Treatment is generally limited to supportive care, including:

  • Anti-diarrheal medication
  • Anti-nausea medication
  • Anticholinergic antispasmodic agent for abdominal pain
  • Pain medication
  • Dietary treatment (to increase caloric intake where needed)
  • Sucralfate for indigestion
  • Sometimes surgery can be recommended to bypass the affected area of the intestine

Acute and chronic radiation enteritis remains an unmet medical need.

Our Approach: SGX201

SGX201 is designed as a topical treatment for the gut. The active ingredient is beclomethasone 17,21-dipropionate (BDP).

BDP is a steroid which can reduce local inflammation but has limited ability to penetrate the body.

By providing a formulation of BDP which coats the inside of the gut with steroid, but isn’t absorbed into the bloodstream, the systemic side effects of steroid treatment are reduced.

SGX201 may be a safe alternative for prevention of acute and chronic radiation enteritis.

How is SGX201 Delivered?

SGX201 is an oral, enterically coated pill containing the active ingredient BDP. The pill is designed to dissolve in the intestine, coating the bottom half of the gastrointestinal tract and providing direct anti-inflammatory action.

What is Known About BDP?

Beclomethasone dipropionate (BDP) is a very well-known steroid that has been used in inhaled products for asthma, in nasal sprays for rhinitis and in skin creams for rashes. It has been used in children and adults for over 40 years. There is a lot of information known about the safety and efficacy of BDP.

Mechanism of Action

As with all corticosteroids, BDP binds to the corticosteroid receptor and has anti-inflammatory action, suppressing the infiltration of inflammatory cells to the local site of action.

The distinguishing feature of BDP is that it does not travel throughout the body easily, meaning that it has a local action without inducing as many side effects throughout the body. This also means that the BDP must be delivered directly to where it is needed – which is reflected in the unique oral formulation that is used in SGX201.

More details on the mechanism of action of SGX201 (BDP) can be found in our Reference Literature.

Clinical Studies & Commercialization

SGX201 would be the first treatment for the prevention of acute and chronic radiation enteritis with concomitant radiation therapy, if approved.


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Phase 2 Trial Design

The Phase 2 trial will be a double-blind, randomized, placebo-controlled trial that will enroll approximately 66 women that plan to receive pelvic radiation as a treatment for cervical or ovarian cancer. The trial will compare the rates of improvement of the signs and symptoms of radiation enteritis.

Previous Clinical Studies with SGX201

A small Phase 1/2 clinical study was completed testing SGX201 in prevention of acute radiation enteritis. Sixteen patients with rectal cancer receiving radiation and chemotherapy prior to surgery were randomized to one of four SGX201 dose groups. The study demonstrated that oral administration of SGX201 was safe and well tolerated across all four dose groups with evidence of a potential dose response with respect to diarrhea, nausea and vomiting.

Previous Nonclinical Studies with SGX201

Previous nonclinical studies with related formulations of BDP have shown that some of the chronic effects of radiation therapy (known as fibrosis) can be mitigated by anti-inflammatory treatment with BDP.

Other Potential Uses for BDP

A topical oral anti-inflammatory with action limited to the gastrointestinal tract may be useful in a number of other inflammatory conditions.

Acute Radiation Syndrome (OrbeShield®)

The SGX201 formulation, combined with another pill containing BDP which dissolves in the stomach, is also being explored in the context of Acute Radiation Syndrome, as a potential therapy in the case of a mass-casualty nuclear accident or attack.

Pediatric Crohn’s Disease

The SGX201 formulation, combined with another pill containing BDP which dissolves in the stomach, is also being explored in the context of Pediatric Crohn’s Disease , an inflammatory bowel disease which in children involves all parts of the intestine.

Regulatory Status

SGX201 has Fast Track designation for the prevention of acute radiation enteritis in the United States.

Intellectual Property

Soligenix has a strong worldwide intellectual property position on the proprietary formulation of BDP as an oral topical treatment for the gastrointestinal tract in Pediatric Crohn’s Disease and related inflammatory conditions of the gut.

Our pipelines focuses on orphan and unmet medical need across a range of indications