Hyperphosphatemia is a complication in patients with chronic kidney disease (CKD) on dialysis and Ilypsa's compound, ILY101 could be one of a number of new non-absorbed polymeric phosphate and potassium binding compounds.
ILY101 is a metal-free, non-absorbed polymeric drug designed for the selective binding and removal of phosphate anions from the gastrointestinal tract. It is being developed for the treatment of hyperphosphatemia in CKD patients on dialysis and works by reducing the systemic absorption of dietary phosphate.
ILY101 is designed to allow for lower daily doses and improved patient acceptance and tolerability in comparison to other products in this class of drugs.
>Ilypsa's current drug candidates are based on tailored non-absorbed polymers, where the polymer itself provides the drug function. By preventing degradation and systemic uptake, the polymeric drugs are designed to act in the gastrointestinal tract and clear the human body through the digestive system.
The non- absorbed feature significantly simplifies toxicology and pharmacology requirements for this class of drugs, leading to superior safety and risk profiles.
"Hyperphosphatemia is a serious disease characterised by abnormally elevated serum phosphate levels that can result in significant morbidity and mortality in end-stage renal disease patients," said Detlef Albrecht, Ilypsa's Chief Medical Officer.
"We are encouraged by the outcome of our Phase 1 study, and believe that ILY101 has the potential to offer an improved treatment option to patients who require chronic phosphate binder therapy."
The Phase 1 study examined the safety and tolerability of single and multiple doses of orally administered ILY101 in twenty-four healthy volunteers.
With the successful completion of Phase 1, the company expects to initiate a Phase 2 study in CKD patients on dialysis.
"We are pleased to have successfully completed our first trial in humans. ILY101 is a compound discovered in-house that we expect to quickly advance to proof of concept in humans."
"Our progress into Phase 2 clinical trials in the next several months is in line with Ilypsa's expectations for faster and lower risk development of non-absorbed polymeric drugs," said Jay Shepard, President and CEO of Ilypsa.
In order to fund the research into this area, Ilypsa, to date has raised $46m (€36m) in Series A and Series B financing rounds. Lead investors include NLV Partners, 5AM Ventures, US Venture Partners, Johnson & Johnson Development Corporation and Delphi Ventures.
A handful of companies have been active in investigating the benefits of nonabsorbed polymeric drugs not only for renal and metabolic disorders but also for reducing high cholesterol levels.
Israeli-based, Semorex is eveloping novel biologically active synthetic polymers that combine the advantages of small molecules with antibodies and other proteins.
Its first internally developed products are therapeutic polymers that selectively remove small molecule toxins found in the gastrointestinal tract (GI Tract).
The polymers are not absorbed into the body's circulatory system, but are excreted from the body together with the targeted substances.
Non-absorbed, non-specific polymeric drugs have a long history of safety for lowering cholesterol. However, performance limitations have restrained their use.