Our Oral Biologic Platform
We are committed to leveraging our expertise in oral enzymes to develop first-of-its-kind targeted therapies that work within the gastrointestinal (GI) tract to limit the downstream effects of metabolic diseases, including kidney stones, gout, and chronic kidney disease.
Click on a program to learn more about what’s in our pipeline
Reloxaliase is a first-in-class, orally administered, non-absorbed enzyme for the treatment of hyperoxaluria. Its formulation was designed to degrade oxalate within the GI tract and limit the systemic absorption of oxalate into the bloodstream. A decrease in systemic absorption of oxalate reduces the burden on the kidney, ultimately reducing the risk of kidney stones and other serious kidney diseases. Clinical trials in healthy volunteers and patients with enteric hyperoxaluria demonstrated that reloxaliase:
- Substantially reduced urinary oxalate excretion in patients with enteric hyperoxaluria
- Was well tolerated, with no drug-related serious or severe adverse events
- Specifically targets oxalate, with minimal to no changes in other urine parameters
We are initially developing reloxaliase for adult patients with enteric hyperoxaluria (a form of the disease that is the result of certain GI disorders that cause fat malabsorption such as Crohn’s disease and complications from bariatric surgery). If approved, it has the potential to help treat 200,000 to 250,000 patients with enteric hyperoxaluria in the US alone. The urirox1 phase3 trial in patients with enteric hyperoxaluria met primary endpoint and second phase 3 trial urirox2 is ongoing.
The FDA has also granted separate orphan drug designations to reloxaliase for the treatment of primary hyperoxaluria (a form of the disease that results from a rare genetic disorder) and for the treatment of pediatric hyperoxaluria.
We have an ongoing phase 3 clinical trial that is actively recruiting patients with enteric hyperoxaluria.
ALLN-346 is a first-in-class orally administered non-absorbed enzyme that breaks down urate in the GI tract. It has the potential to treat hyperuricemia and lower the risk of urate-related complications, including gouty flares, arthritis, and urate-based stones in the kidney, bladder, or urinary tract. If approved, ALLN-346 may be used to help treat approximately 375,000 patients living with uncontrolled gout and related advanced CKD.
We are initially targeting ALLN-346 for patients with hyperuricemia and gout who have moderate to severe CKD.
Oral Biologic Platform
We are working to expand our pipeline of first-in-class oral enzyme therapeutic candidates to treat patients with rare and severe metabolic disorders.
Expanded Access Policy
We are committed to bringing patients access to our medicines. This requires conducting rigorous clinical trials and obtaining marketing approval by the U.S. Food and Drug Administration (FDA) and other regulatory authorities.
The best way for eligible patients to access our investigational products is through participation in our clinical trials. Our trials are designed to establish whether a therapeutic candidate is safe and effective for use. After trials are completed, the information gained is submitted to regulatory authorities such as the FDA. These authorities review the information and determine if it may be prescribed by health care providers.
However, some patients who are not part of these trials but meet certain eligibility criteria may benefit from our products. These patients can request access to the investigational drug through their physician. These situations are typically referred to as Expanded Access Programs (EAP).