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Press Release

Bone Therapeutics SA completes patient recruitment for Phase IIA Spinal Fusion study with ALLOB®


Posted on: 19 Feb 18

Press release

Bone Therapeutics completes patient recruitment for Phase IIA Spinal Fusion study with ALLOB®

Efficacy and safety results expected in mid-2019

Promising interim efficacy and safety data already reported

Gosselies, Belgium, 19 February 2018, 7am CET - BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the bone cell therapy company addressing high unmet medical needs in orthopaedics and bone diseases, today announces that it has completed the recruitment of its Phase IIA lumbar spinal fusion study with its allogeneic bone-cell therapy product, ALLOB®. Given this timing, efficacy and safety data for the full set of 32 patients are expected mid-2019, following a follow-up period of 12 months.

Thomas Lienard, Chief Executive Officer of Bone Therapeutics, commented: "We are pleased to announce recruitment of the last patient into our Phase IIA spinal fusion study with ALLOB®, on schedule. Our promising interim results showed bone formation in ALLOB®-treated patients, who also reported significant improvement in pain and day to day functional abilities. We look forward to reporting the full data set in mid-2019 as further positive results would continue to confirm the potential of our allogeneic cell therapy product to provide patients and physicians with improved treatment outcomes."

The Phase IIA trial in lumbar spinal fusion is designed to evaluate the safety and efficacy of the addition of ALLOB® to the standard of care procedure, in which an interbody cage with bioceramic granules is implanted to achieve fusion of the lumbar vertebrae. Endpoints of the study include radiological assessments: the evaluation of fusion and intervertebral mobility; and clinical assessments: the improvement in functional disability and reduction in pain; and safety assessments. Positive interim safety and efficacy results were reported in September 2017.

About Spinal Fusion

Due to ageing populations and sedentary lifestyles, an increasing amount of people are suffering from degenerative spine disorders. Spinal fusion is considered as the gold standard surgery for treating a broad spectrum of degenerative spine disorders to relieve pain and improve function. Spinal fusion consists of bridging two or more vertebrae with the use of a cage and graft material, traditionally autologous bone graft, - placed into the intervertebral space - for fusing an unstable portion of the spine or immobilizing a painful vertebral motion segment. Over 500,000 lumbar spinal fusions are performed each year in Europe and the US and the market is growing at a rate of 5% per year. Although spinal fusion surgery is routine, non-union and failure to relieve pain are still frequent and up to 35% of spinal fusion patients are not completely satisfied with their surgery.

About Bone Therapeutics

Bone Therapeutics is a leading cell therapy company addressing high unmet needs in orthopaedics and bone diseases. Based in Gosselies, Belgium, the Company has a broad, diversified portfolio of bone cell therapy products in clinical development across a number of disease areas targeting markets with large unmet medical needs and limited innovation.

Our technology is based on a unique, proprietary approach to bone regeneration which turns undifferentiated stem cells into "osteoblastic", or bone-forming cells. These cells can be administered via a minimally invasive procedure, avoiding the need for invasive surgery.

Our primary clinical focus is ALLOB®, an allogeneic "off-the-shelf" cell therapy product derived from stem cells of healthy donors, which is in Phase II studies for the treatment of delayed-union fractures and spinal fusion. The Company also has an autologous bone cell therapy product, PREOB®, obtained from patient`s own bone marrow and currently in Phase III development for osteonecrosis, and is also partnered with Asahi Kasei Corporation for the development and commercialisation of PREOB® in Japan.

Bone Therapeutics` cell therapy products are manufactured to the highest GMP standards and are protected by a rich IP estate covering nine patent families. Further information is available at: www.bonetherapeutics.com.

Contacts

Bone Therapeutics SA
Thomas Lienard, Chief Executive Officer
Jean-Luc Vandebroek, Chief Financial Officer
Tel: +32 (0)2 529 59 90
investorrelations@bonetherapeutics.com

For Belgium and International Media Enquiries:
Consilium Strategic Communications
Amber Fennell, Jessica Hodgson, Hendrik Thys and Lindsey Neville
Tel: +44 (0) 20 3709 5701
bonetherapeutics@consilium-comms.com

For French Media and Investor Enquiries:
NewCap Investor Relations & Financial Communications
Pierre Laurent, Louis-Victor Delouvrier and Nicolas Merigeau
Tel: + 33 (0)1 44 71 94 94
bone@newcap.eu

For US Media and Investor Enquiries
Westwicke Partners
John Woolford
Tel: + 1 443 213 0506
john.woolford@westwicke.com

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors` current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person`s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

GlobeNewswire
globenewswire.com

Last updated on: 20/02/2018

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