November 8, 2016
By Alex Keown, BioSpace.com Breaking News Staff
BRUSSELS – Shares of Bone Therapeutics dropped slightly this morning after the company announced a change in leadership and ended plans to hold a clinical trial in the United States.
Bone Therapeutics scrapped plans to initiate a planned Phase IIb/III clinical trial of its autologous osteoblastic cell therapy product PREOB in the U.S. in favor of its spinal fusion therapy. In October, Bone Therapeutics announced positive data from its Phase IIa spinal fusion trial with ALLOB, a first-in-class allogeneic differentiated osteoblastic (bone-forming) cell therapy product developed for the treatment of orthopedic conditions and bone diseases. Allogeneic cell therapy involves the harvesting of cells from a healthy donor, rather than from the treated patient. During the mid-stage trial the company showed not only a successful fusion of the spine, but also clinical improvements in function, pain and health at about six months following the treatment.
In a third quarter earnings announcement, Bone Therapeutics said it will focus on the ALLOB platform, which the company said provides the strongest chance of striking a collaborative deal with another company. Bone Therapeutics’ focus will primarily be aimed at clinical development of ALLOB in Europe and the United States, the company said.
Additionally, the Belgian company tapped Thomas Lienard as its new chief executive officer. Lienard joined the company last year as its chief business officers in charge of business development and strategic planning. He was appointed interim chief executive officer in October after Enrico Bastianelli stepped down from the top spot he held for 10 years due to personal reasons, according to a company announcement. The company wasted little time in the transition as it continues to push its key clinical programs in spinal fusion therapy and prepare for its planned commercialization of an osteonecrosis treatment.
“We continued to see strong progress across our pipeline in the third quarter following encouraging efficacy and safety data from the Phase II and III programs in delayed-union fractures, spinal fusion, osteoporosis and osteonecrosis in the first half. We announced positive efficacy data for the ALLOB Phase IIA spinal fusion trial shortly after the period end, strengthening our confidence in the potential of ALLOB as an important new treatment option,” Lienard said in a statement. “We are focused on targeting our resources on those programs with the greatest commercial and partnering potential and on moving our key programs towards commercialization.”
Michel Helbig, chairman of Bone Therapeutics’ board of directors, said the appointment of Lienard to CEO gives the company “the right industry, commercial and clinical expertise to steer the Company through the next phase of growth.”
In addition to the appointment of Lienard, Bone Therapeutics reported third quarter earnings, showing cash and cash equivalents of 22.46 million euros as of Sept. 30. The company said it also reduced some operating costs in the first three quarters of 2016 from 9.93 million euros in 2015 to 8.95 million euros for this year.
