Preparing to enter the clinic with its two lead products in renal disease, Ilypsa Inc. raised $36 million in its second financing round.

Ilypsa intends to use the funds to complete preclinical work and begin clinical development of ILY-101, a metal-free polymeric phosphate binder, and ILY-105, a potassium-binding polymer, said Gerrit Klaerner, vice president of business development and technology assessment, adding that the financing should sustain the company into 2007.

"It should allow us to complete proof-of-concept studies," he said.

The private placement of Series B preferred stock was led by new investors US Venture Partners and Delphi Ventures, both of Menlo Park, Calif., and Johnson & Johnson Development Corp., of New Brunswick, N.J. Other investors included San Francisco-based CMEA Ventures, Newton, Mass.-based Mediphase Venture Partners and Menlo Park, Calif.-based Sprout Group and 5AM Ventures.

The company's discovery platform is a high-throughput screening system created by Symyx Technologies Inc. Santa Clara, Calif.-based Ilypsa began operations as Symyx Therapeutics Inc. in May 2003, a spinout of Symyx Technologies, and raised about $10 million in its Series A round to cover early research costs. Last year, the company changed its name to Ilypsa, though Symyx still remains a shareholder.

The screening system is designed to develop non-absorbed polymeric drugs. As opposed to typical small molecules or biologics, the non-absorbed products start off with a promising safety profile because they do not enter a patient's bloodstream at all, Klaerner said.

"It goes into the GI tract, finds the things that are bad for you and then passes out of the system," he told BioWorld Today.

Cambridge, Mass.-based Genzyme Corp.'s Renagel is a prominent example of a non-absorbed phosphate binder. Renagel aims to control phosphorus levels in patients with chronic kidney disease (CKD) who are on hemodialysis without causing hypercalcemia, a condition resulting from too much calcium in the bloodstream. But patients on Renagel can take up to five tablets per meal, Klaerner said, so, with the development of ILY-101, Ilypsa is "trying to get it down to one pill per treatment,"

Patients on dialysis "have to take pills every day of their lives," he added.

ILY-101 is about six months away from beginning Phase I trials.

The company's second product, ILY-105, is expected to begin human testing within the next nine to 12 months. ILY-105 is a potassium binder that is being designed as an improved version of a generic. Patients with CKD are not able to excrete potassium from the body. ILY-105 is being designed to bind with potassium and carry it out through the digestive tract.

"Clinical trials normally take a long time because safety is the most important thing," Klaerner said. "That's the advantage with the non-absorbed nature of our drugs"

Since those types of products are known for their safety profiles, Ilypsa hopes to conduct rapid trials with small clinical groups.

Genzyme's Renagel "took less than three years from IND to NDA," he said. "That's what we'd like to do."

Ilypsa's growing preclinical pipeline also includes a sodium binder that is being investigated as a treatment for renal disease and chronic heart failure. The company also has compounds in early development for metabolic disease and infection.

The anti-infective product "will be partnered quickly," Klaerner said, since that is not the company's focus area. Ilypsa likely will start looking for partners for its metabolic and heart disease products further along in clinical development, while handling late-stage trials and commercialization of the renal disease products itself since only a small sales force is required.

Ilypsa has 37 employees, though Klaerner said he expects that number to increase to the mid-40s as Ilypsa's products get closer to the clinic.

Following the financing, Deepa Pakianathan, of Delphi Ventures; Jonathan Root, of US Venture Partners; and Brad Vale, of Johnson & Johnson Development, joined the company's board.

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