Zelos Therapeutics Inc. closed a C$14 million (US$9.4 million) first round of financing, funds the company plans to use in pushing clinical development of its lead parathyroid hormone (PTH) analogue for osteoporosis.
"I think the key for us is our technology and the product advantage that our class of PTH will bring to that world," Godfrey Marchand, Zelos' vice president of corporate affairs, told BioWorld Today. "That's certainly the attractive aspect of the company."
Zelos, with administrative offices housed in Waltham, Mass., has developed Ostabolin-C in large part through licenses to patents and technologies that stem from a 10-year undertaking on the part of Canada's National Research Council called the Parathyroid Hormone Project. The Ottawa, Ontario-based organization is developing next-generation analogues of PTH that have the same or improved bone formation efficacy as seen with first-generation PTH analogues, without unwanted side effects.
Forteo (teriparatide), a PTH-class product from Indianapolis-based Eli Lilly and Co. approved late last year, as well as other development-stage products, have advanced osteoporosis treatment, though their propensity to stimulate the release of calcium into blood can cause hypercalcemia.
"That seems to be the Achilles' heel for PTH, not necessarily for PTH as an injectable but for PTH as everybody tries to develop alternative routes of administration," Marchand said, pointing to a desire to exploit oral or pulmonary delivery options. "The bioavailabilty will be lower but the amount of product given in each dose would be higher. I think our product would turn out to be safer than the first generation of PTH products."
All the early peptide products are delivered via injection. Early findings show that Ostabolin-C, a 31-amino-acid PTH analogue also delivered through injection, is osteogenic, stable and does not induce hypercalcemia in animal studies, the company said.
"Ours is a shorter peptide," Marchand said. "We have eliminated one of the two cascades of activity of PTH, so we expect that we will have a better safety profile as it relates to hypercalcemia."
Zelos plans to begin Phase I trials before the end of the year - studies designed to evaluate the product's side-effect and toxicity profile as well as determine dosing for use in further trials. Portions of the Series A financing also will be used to fund early Phase II work.
At the same time, Zelos will apply funds to increase its five-employee work force, expanding its clinical and senior management staff to push the drug's development. Two researchers from the Canadian research organization, James Whitfield and Gordon Willick, will work with the company as part of a continuing collaboration. Founded in August 2000 by the National Research Council and Cromedica Prime Inc., a contract research organization also based in Ottawa, Zelos maintains research facilities in the Canadian capital city.
Longer term, Marchand said the company plans to seek a partner to further develop the drug and help offset high costs of Phase III trials - expensive in osteoporosis given the number of patients and time needed to complete efficacy studies.
Other down-the-road plans include studying the drug in alternatively administered formulations such as oral or inhalable. Marchand also said Zelos' strategy calls for studying PTH-class drugs in dermal applications, such as psoriasis.
Seaflower Ventures, also of Waltham, led the financing along with VenGrowth Capital Partners Inc., of Toronto. Additional funding was provided by Genesys Capital Partners, of Toronto, which in December 2001 provided C$1 million in seed financing for Zelos.