BioSenic puts Phase IIb ALLOB trial on hold.
Prior efficacy unmatched but excellent safety profile confirmed, timing of ALLOB administration for optimal bone repair to be reevaluated
Mont-Saint-Guibert, Belgium, June 19 2023 – BioSenic (Euronext Brussels and Paris: BIOS), the clinical stage company specializing in serious autoimmune and inflammatory diseases and bone and cartilage cell repair, today announces the decision to suspend its interventional trial on fracture healing, using the ex-Bone-Therapeutics lead product, ALLOB. This decision follows negative results obtained for the primary endpoint in the exploratory Phase IIb trial (ALLOB IIb), which focused on safety and treatment timing efficacy.
The aim of this Phase IIb study was to evaluate the efficacy of administering ALLOB (derived from mesenchymal stem cells) a couple of days after a bone fracture to accelerate fracture healing. In contrast to the previous successful Phase IIa, where ALLOB was administered after 3.5 to 7 months, in 21 long bone fractures with documented delayed- or non-union, early application of ALLOB did not accelerate the fracture healing process. Lieven Huysse, MD, Chief Medical Officer of BioSenic, further reports: “the current ALLOB Phase IIb study in 57 patients (randomized 1:1 versus placebo) can confirm the excellent safety profile of ALLOB injections, with no reported serious adverse events related to the experimental treatment”. The compilation of the two clinical studies and the pre-clinical data also suggest that the administration of ALLOB, in order to positively influence a complex bone repair process, should be carried out outside the acute early post-traumatic inflammatory period.
In short, ALLOB-treatment remains of potential benefit as an add-on to standard of care, at the right time, to improve recovery from extreme bone damage. This should be of great help in either after trauma or after bone surgeries. After difficult fractures, the rate of late non-union varies with fracture location: tibia is the most likely to be affected by non-union. Failure of bone fracture healing, the real target of our cell repair therapy, occurs in 5 percent to 10 percent of all patients.
BioSenic's clinical activities will now focus on its Phase III cGVHD trial with oral arsenic trioxide (OATO). BioSenic, through the Medsenic company autoimmune disease platform had completed a successful phase II trial targeting cGVHD (chronic Graft vs Host Disease), with a demonstrated efficacy of more than 75 percent on the Full Study Population and 84 percent on the Per Protocol Population. A phase III study is now in the starting blocks to reach the market as quickly as possible, through the framework of an expedite 505(b)(2) FDA regulatory pathway.
“BioSenic has chosen to focus resources on its most promising and advanced asset, the Medsenic OATO autoimmune disease platform. As a result, it can concentrate on the late-stage phase III trial of oral arsenic trioxide targeting chronic graft-versus-host disease. A 505 (b)2 procedure is on track with the FDA,” said François Rieger, PhD, Chairman and Chief Executive Officer of BioSenic. “We want to make this new cGvHD treatment available as quickly as possible for patients who currently have no other serious therapeutic alternative. The decision to halt the clinical development on difficult tibial fractures enables BioSenic to add additional resources for the development of the OATO platform and its current indications.”
About BioSenic
BioSenic is a leading biotech company specializing in the development of clinical assets issued from: (i), the allogeneic cell therapy platform ALLOB and (ii) the Arsenic TriOxide (ATO) platform. Key target indications for the platforms include Graft versus Host Disease (GvHD), Systemic lupus erythematosus (SLE), Systemic Sclerosis (SSc) and high-risk tibial fractures.
Following the merger in October 2022, BioSenic combines the strategic positionings and strengths of Medsenic and Bone Therapeutics. The merger also enables Biosenic to add to its innovative cell therapy platform and strong IP for tissue repair protection with an entirely new arsenal of various anti-inflammatory and anti-autoimmune formulations using the immunomodulatory properties of ATO/OATO.
BioSenic is based in the Louvain-la-Neuve Science Park in Mont-Saint-Guibert, Belgium. Further information is available at http://www.biosenic.com.
