Novosteo Inc. will use funding to advance development of NOV004 for the treatment of bone fractures, other bone diseases and support Phase 1 clinical trials.

Novosteo Inc., a preclinical-stage biotechnology startup focused on the development of bone-targeted therapeutics, announced Thursday (February 4) the closing of a $5.5 million in Series A financing to advance its development of the first-ever targeted bone anabolic agent NOV004.

The compound has shown promise in live animals in the acceleration of fracture healing when delivered systemically. NOV004 is unique in that it concentrates at the fracture site while avoiding accumulation in the rest of the body. Proceeds from the financing will be used to advance  NOV004 into clinical development that will begin in the first half of 2021.

Bone injuries and disease are one of the most challenging health issues facing all ages, especially for the elderly. Despite the advent of preventive measures, one in three hip fracture patients who are 65 and older will die within a year; many deaths occur as a result of the complications due to slow fracture healing and long-term immobilization. About 40% of those who survive require assistance to walk, according to the National Institutes of Health. Across the U.S., there are about 6 million fractures annually, 3.5 million emergency room visits and direct health care costs of near $30 billion related to bone injuries. In addition, bone fractures represent 26% of combat extremity wounds.

Financing to support Novosteo’s drug development came from Kairos Ventures, joined by BioCrossroads Ventures, Elevate Ventures and Purdue Research Foundation.

“The funding provided by this group of highly respected investors supports the promise of the Novosteo technology and team,” said Dan Hasler, Novosteo chairman of the board and past chief marketing officer of Eli Lilly and Co. “Despite the availability of preventative treatments, too many people continue to suffer and die from difficult or slow-to-mend bone fractures.”
The company also announces that William (Bill) Boyle, Ph.D. will join the team as president and CEO. Boyle is a senior executive with 30 years of pharmaceutical and biotechnology industry experience including leadership roles in private startup and multinational companies involved in the research, development and commercialization of biologic therapeutics.
“The technology approach of Novosteo has broad applications in the treatment of bone diseases, and we are rapidly developing a bone-targeted anabolic peptide for multiple uses,” Boyle said. “Using our current venture backing we will initiate Phase 1 study of our lead program, NOV004, and pursue future partnering events and fundraising to expand NOV004 indications for areas with high unmet medical needs and accelerate development of our pipeline.”
Boyle previously served as chief of translational medicine at BioAtla Inc. [NASDQ: BCAB] and founder and president of AnaptysBio [NASDQ:ANAB]. As a director of research at Amgen, his research helped to elucidate the OPG/RANK/RANKL signaling pathway in bone and led the discovery and development the RANKL antagonists, including denosumab (Prolia and Xgeva) for the treatment of pathologic bone loss resulting from osteoporosis, treatment-related bone loss and cancer.
Joining the Novosteo board of directors from Kairos Ventures is Alex Andrianopoulos, venture partner and chief research and development officer.
“Kairos Ventures invests in startups rooted in inventions produced in labs of the leading scientific minds of our times. Novosteo is exactly this type of startup based on technology invented at Phil Low’s highly regarded research lab at one of the leading universities in our partner network, Purdue University,” said Andrianopoulos. “Novosteo is poised to revolutionize treatment of bone injury by rapidly accelerating healing, a key factor in lowering co-morbidity and mortality rates especially in the elderly. We are proud to be in a position to support professor Phil Low and Stewart Low in their efforts on Novosteo.”