Alcresta Pharmaceuticals, a specialty pharmaceutical company focused on developing innovative enzyme-based products for gastrointestinal and rare disease, has announced it received de novo approval from the U.S. Food and Drug Administration (FDA) to market Relizorb™ (immobilized lipase). Relizorb is a first-of-its kind digestive enzyme cartridge designed to mimic the normal pancreatic function by breaking down fats in enteral tube feeding formula. By breaking down these fats from enteral tube feeding formulas prior to ingestion, Relizorb allows for the delivery of increased absorbable calories from fatty acids and monoglycerides to adults who are partially or completely unable to breakdown and absorb fats.
Fat malabsorption is most common in individuals who cannot produce adequate amounts of digestive enzymes because of compromised pancreatic function. In certain people, changes in gastric, duodenal, liver and pancreatic physiology can also dramatically impact malabsorption of critical nutrients in particular fat absorption. In these individuals, incomplete hydrolysis (break down) of fats from enteral tube feeding can lead to decreased caloric intake, reduced digestion of essential fats, in particular long-chain polyunsaturated fatty acids (omega-3), deficiencies of fat-soluble vitamins and increased gastrointestinal symptoms. These negative outcomes can significantly impact quality of life and nutritional status and can adversely affect a person's ability to maintain or gain weight and absorb necessary nutrients.
"The approval of our flagship enzyme-based product Relizorb marks an important and hopeful day for the thousands of people who rely on daily enteral feeding to support their medical and nutritional needs," said John Tucker, chief executive officer of Alcresta. "The Relizorb approval is also a key milestone for Alcresta as we complete the transition to a commercial-stage organization, and look forward to bringing Relizorb to market in the U.S. and subsequently to patients who could benefit in Europe and other regions."
Many patients face the challenge of attaining proper nutrition, which is required as a critical part of maintaining overall health and disease recovery. According to the Cystic Fibrosis Foundation's patient data report, a relationship has been established in cystic fibrosis (CF) between good health outcomes and patients' nutritional levels, reinforcing the need for individuals to maintain adequate weight gain. Specifically, low levels of certain fatty acids contribute inflammatory characteristics of CF, and negatively affect a person's ability to maintain or gain weight and absorb critical fatty acids and other nutrients.
In 2013, Cystic Fibrosis Foundation Therapeutics, the nonprofit drug discovery and development affiliate of the Cystic Fibrosis Foundation, issued an award to Alcresta to develop products to improve the management of enteral feeding in people living with CF.
"This is an important development for people with cystic fibrosis, especially those who rely on tube feeding as an important source of supplemental nutrition," said Preston Campbell, M.D., president and CEO of the Cystic Fibrosis Foundation. "We congratulate Alcresta on the approval of this new treatment approach."
It is estimated that more than 344,000 people of all ages in the U.S. are receiving enteral nutrition at home. There are an additional 613,000 patients in intensive care units (ICU) that use enteral feeding. Based on market survey data, 10-20 percent of people with CF and 20-40 percent of people with pancreatic and stomach cancer use enteral tube feeding on a daily basis.
"The FDA clearance for Relizorb signifies a critical first step forward in our ongoing commitment to developing additional enzyme-based products designed to improve the overall health of people with gastrointestinal and rare diseases, as well as those with specific nutritional needs," said Robert Gallotto, co-founder and president of Alcresta. "We are committed to bringing innovative products to people in need of improved nutritional care. This is the first in a number of enzyme-based products in development to support the management of patients suffering from acute or chronic conditions that impact nutritional needs."
Relizorb is a first-of-its kind digestive enzyme cartridge designed to mimic the function of pancreatic lipase. Relizorb is designed for use by adults on enteral tube feeding who have trouble breaking down and absorbing fats. Relizorb is developed using Alcresta's proprietary enzyme immobilization technology. The active ingredient in Relizorb is the digestive enzyme lipase, attached to polymeric carriers together called iLipase®.
As the enteral tube feeding formula passes through Relizorb, it makes contact with the iLipase and the fat in the formula is broken down to its absorbable form (fatty acids and monoglycerides) prior to ingestion. The iLipase remains in the cartridge and does not become part of what is ingested. Relizorb has been shown to break down 90 percent of fats in most enteral feeding tube formulas, including the most difficult to breakdown long-chain polyunsaturated fatty acids, such as docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA) and arachidonic acid (AA), which are critical for growth and development.
Over time, decreased fat absorption can lead to deficiencies in important fatty acids, such as omega-3. A balanced ratio of omega-3 to omega-6 fatty acids is beneficial in maintaining normal development and overall health.