Alcresta has raised $49.4 million in a Series C financing to support the launch of its novel digestive enzyme cartridge Relizorb. Up first, it's aiming for the sub-set of cystic fibrosis patients who rely upon a feeding tube for nutrition.
The company sits right at the nexus of the nutritional, biotech and medical device industries. Its aim is to introduce a series of products that make it easier for gastrointestinal and rare disease patients to digest long-chain polyunsaturated fatty acids, or so-called "healthy fats".
It got its first FDA clearance late last year with a de novo approval of its digestive enzyme cartridge Relizorb. It’s designed to attach to an enteral feeding tube to help better break down the fats in the formula for adults whose bodies are unable to do so on their own. The idea is to mimic normal pancreatic function.
“When we started with this concept, we knew that we could help with nutrition in some shape or form. We realized that there was a unique regulatory path that had never been followed before. We are a medical device. We are focused on high science, nutrition—and on outcomes. Nutrition companies don’t look at outcomes,” Alcresta co-founder and president Robert Gallotto told FierceBiotech.
Now, Alcresta has dug deep into the pockets of its investors to launch its first product. The Newton, MA-based company near $50 million raise saw crossover investor Athyrium added to its existing VCs that include Bessemer Venture Partners, Frazier Healthcare and Third Rock Ventures.
Alcresta's Gallotto confirmed to FierceBiotech that this fundraising amount, posted in an SEC filing, is accurate.
The startup launched Relizorb earlier this month, becoming the first approved product to break down or hydrolyze fats in enteral tube feeding formulas. Alcresta will start with a sales strategy focused on adult cystic fibrosis patients who depend on enteral feeding. About 90% of cystic fibrosis patients have fat malabsorption with about 10% to 15% of CF patients must rely upon enteral nutrition, according to the company.
“We did a collaboration in 2013 with the CF Foundation. It allowed us to move the product very quickly through their clinical development network and their scientific expertise,” Gallotto said. “This is the start of a number of different products in CF.”
The active ingredient in the Relizorb cartridge is the digestive enzyme lipase attached to polymeric carriers, together called iLipase. As the formula passes through Relizorb, it is broken down into absorbable fatty acids and monglycerides prior to ingestion. iLipase remains in the cartridge and is not ingested itself.
Relizorb breaks down more than 90% of fats in most enteral feeding tube formulas--including the most difficult to breakdown long-chain polyunsaturated fatty acids, which are also among the most beneficial, such as docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA) and arachidonic acid (AA).
- here is the SEC filing
- and here is the launch release
Related Articles:
Biotech vets pick up $10M B round for startup Alcresta
Third Rock, biotech VCs make baby formula gambit
UT Southwestern researchers identify an enzyme as a major culprit of autoimmune diseases
Celgene gambles $50M on Abide and its R&D work on enzyme 'superfamily'