Bone Therapeutics Looks To ALLOB Data Progress
Executive Summary
Following its IPO in 2015, Belgium's Bone Therapeutics has been making progress on its allogeneic osteoblastic cell product, ALLOB, which recently appointed CEO Thomas Lienard pegs as the company's most valuable platform. With the product currently in Phase II trials, Lienard shares his plans for the company.
Since raising $37m in a 2015 IPO, Belgian cell therapy specialist Bone Therapeutics has accelerated early clinical trials for its allogeneic platform product ALLOB in spinal fusion (Phase IIa) and delayed union fractures (Phase II), with results from eight patients from each indication already confirming safety and suggesting efficacy. In an interview with Scrip, the company noted that it expected interim results from 16 patients, from both trials, in September and was confident that they would be positive, maybe positive enough to accelerate development even further.
Thomas Lienard
In addition to the allogeneic platform, ALLOB, which uses cells originating from a healthy donor to aid bone formation in damaged bone, Bone Therapeutics is also developing a personalized platform called PREOB. PREOB is an autologous bone cell therapy derived from the patient's own bone marrow and is currently in a double-blind controlled Phase III trial for osteonecrosis of the hip, which is recruiting patients in five European countries.
Lienard was appointed CEO of the company in 2016, after serving as chief business officer for a year. He said that the company had progressed far since its IPO with the development of its allogeneic platform and the progress of related trials being the most significant milestone.
"We were at the very beginning of the development at the time of the IPO, and since then we have progressed significantly in those trials and have started getting results suggesting the product's safety," he told Scrip.
Since the therapy itself requires the introduction of donor cells into the patient, there is a possibility of the patient's body rejecting foreign matter. However, Lienard is positive as the initial results from the current studies are not yet seeing any concerns.
Trial Outlook
Looking to the future, Lienard said that if the interim results from the delayed-union Phase II trial are positive enough, the company will be able to stop the study prematurely. It also expects to finish the recruitment of the 32 patients for the Phase IIa spinal fusion trial at the end of year, enabling it to move forward to next stages of the development.
"We have progressed significantly in trials and have started getting results suggesting the product's safety" – Bone Therapeutics CEO Thomas Lienard
With no announced commercial partnerships, Lienard said that Bone Therapeutics would seek different relationships depending on geographical locations. For example, in Japan or South East Asia, the company is looking for licensing partners, in the US it is looking for co-development and commercialization partners and for Europe, Lienard said the company was comfortable with doing trials here.
There are no firm plans to expand the technology to further indications at the moment, but Lienard said the company had thought about where its products could bring more value in other bone indications.
"We have a lot on our plate and are in a position of showing that our product works, they are safe and they can reach the patients," Lienard said.