BioSenic Appoints Lieven Huysse, MD, as Chief Medical Officer (CMO)

BioSenic, the company specializing in serious autoimmune and inflammatory diseases and cell repair, today announces it has appointed Lieven Huysse, MD, as permanent Chief Medical Officer (CMO), effective 17 April 2023. Lieven Huysse will succeed Michel Wurm’s, MD, who was appointed as Chief Medical Officer ad interim to drive forward the development of BioSenic platforms. Michel has been a key element in the development of Medsenic and BioSenic during the last 18 months.

Lieven will be responsible for continued progression of both BioSenic late-stage assets:

• The ALLOB MSC platform using cells with immune privilege, anti-inflammatory properties and the ability to differentiate into bone tissues when injected into the specific bone sites to be regenerated or repaired. The Phase 2b trial of ALLOB, a randomized, double-blind, placebo-controlled study in patients with high-risk tibial fractures, will report decisive key results in Q2 2023. Lieven will help progress this trial to conclusion. This includes overall responsibility for liaising with the CRO nominated for the trial and liaising with investigators in the thirty-five trial centers across seven EU countries.
• For the autoimmune ATO platform, Lieven will also be focused on the start of the Phase 3 trial in cGvHD, as well as the Phase 2b trials in systemic lupus, and systemic sclerosis.

“BioSenic is now driving hard to speed up clinical development across all our treatment platforms. We have now optimized statistical analysis and completed recruitment for our Phase 2b clinical trial with our allogeneic bone cell therapy product, ALLOB. For our lead API arsenic trioxide platform, designed to target serious inflammatory and autoimmune conditions, our Phase 3 trial in chronic Graft versus Host Disease is on track to start this year, and Phase 2b trials in two other indications, systemic lupus, and systemic sclerosis to start later on. We have also just announced we have gained more insight on the mechanism of action of ATO and optimized ideal formulations to maximize efficacy and minimize side effects for systemic sclerosis. In addition, we have re-evaluated the results of the Phase 3 trial of BioSenic’s enhanced viscosupplement JTA-004 targeting knee osteoarthritis, opening up fresh clinical development options,” said Prof. François Rieger, President and CEO of BioSenic.

“As a result of these clinical progresses, this is an ideal time for us to appoint Lieven as CMO. His experience and expertise will be invaluable as we seek to bring therapies to patients suffering from a range of underserved conditions with few, if any, alternative therapeutic options. These next clinical developments will be key value creation milestones for BioSenic throughout 2023 and into 2024. In addition, these late-stage clinical progressions will enable BioSenic to start the process of engaging with industrial partners to co-develop late-stage clinical projects and to look at other targets of interest in autoimmune diseases and cancer. I would like to thank Michel for his invaluable and extensive contribution over the past months to continuing to push our pipeline of candidates.”

Lieven has been selected as CMO for his extensive expertise in the biopharma and medical device industries. This includes the managing multi-center international clinical studies, including pre-market approval studies for submission to regulatory authorities including the US FDA, reimbursement authorities and Key Opinion Leaders management. He has gained over eight years of experience in immunology, as well as in the diabetes, allergy, cardiovascular and psychiatry sectors. He has 17 years of experience in the medical device sector with knee, hip and spine, as well as with trauma, cardiovascular and endovascular products. He has held senior leadership positions in a number of European headquarters, including in Belgium, Switzerland, Spain and the Netherlands. He has served as CMO for Anaconda Biomed S.L., senior director of medical affairs at Intrinsic Therapeutics, Inc., director of clinical and regulatory affairs at Wright Medical EMEA (now Microport®), medical director for Menarini Group, global brand medical manager for Switzerland-based UCB Farchim, manager clinical Affairs EMEA at Stryker Corp. and Medical Advisor EMEA at Janssen.

“BioSenic is now driving late-stage clinical development of two highly innovative platforms, and currently targeting four indications with its cell therapy and ATO platforms. BioSenic, after its merger, has brought together two teams that are cross-pollinating to rapidly advance this diverse pipeline through clinical development. As CMO, I will now be responsible for driving through clinical candidates that can impact a wide range of patients suffering from a variety of conditions and make a meaningful difference to the lives of large number of patients,” said Lieven Huysse, Chief Medical Officer, BioSenic. “These developments mean joining BioSenic as CMO is far too good an opportunity to miss. I will be able to make a significant contribution to further investigation of the medical characteristics and mechanisms of action of the therapies, and continue to expand BioSenic’s pipeline of indications, and move the late-stage trials in order to bring us towards the market as quickly as possible.”