BioSenic Puts Trial for MSC-Derived Therapy ALLOB on Hold Following Disappointing Efficacy Results

BioSenic has paused its phase 2b trial clinical trial (NCT04432389) evaluating ALLOB, an investigational allogeneic mesenchymal stem cell (MSC)-derived therapy intended to accelerate healing of bone fractures, in response to negative results obtained for the study’s primary efficacy end point.¹

In the phase 2b study, ALLOB was administered to patients with high-risk tibial fractures just a few days following bone fracture. This short-term application of the treatment differentiates the phase 2b study from the earlier phase 2a study, in which patients with delayed or nonunion long bone fractures received ALLOB 3.5 months to 7 months following bone fracture. BioSenic noted that unlike in the phase 2a study, in the phase 2b study there was no acceleration of the fracture healing process observed following administration of ALLOB. Despite the lack of positive efficacy results, the company indicated that the safety profile of ALLOB was strong in the phase 2b study.

“The current ALLOB phase 2b study in 57 patients (randomly assigned 1:1 versus placebo) can confirm the excellent safety profile of ALLOB injections, with no reported serious adverse events related to the experimental treatment,” Lieven Huysse, MD, the chief medical officer of BioSenic, said in a statement.¹

The company stated that based on the findings from earlier clinical studies and preclinical research, it still sees potential for ALLOB as a treatment applied in addition to standard of care treatment at a later timepoint than that used in the phase 2b study, after the acute early posttraumatic inflammatory period has ended. That said, the company noted that in light of the disappointing new efficacy findings, it will shift its priorities to advancing the development of its oral arsenic trioxide (OATO) platform, which is currently being evaluated in a phase 3 clinical trial for the treatment for chronic graft vs host disease (cGVHD).

“BioSenic has chosen to focus resources on its most promising and advanced asset, the Medsenic OATO autoimmune disease platform,” François Rieger, PhD, the chairman and CEO of BioSenic, added to the statement.¹ “As a result, it can concentrate on the late-stage phase 3 trial of oral arsenic trioxide targeting chronic graft-versus-host disease. A 505 (b)2 procedure is on track with the FDA. 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.”

BioSenic is a recently formed company resulting from the October 2022 merger of Bone Therapeutics, which had previously been developing ALLOB, and Medsenic, which had previously been developing the OATO platform. Bone Therapeutics experienced an earlier disappointment in late 2021, when JTA-004, its investigational intraarticular injectable consisting of a mix of hyaluronic acid, plasma proteins, and a fast-acting analgesic, did not meet primary and secondary end points in a phase 3 clinical trial (NCT04333160).² At the time, the company announced that it would be shifting its focus to advancing the development of ALLOB. Later, in July 2022, Bone Therapeutics announced that it would be making adjustments to the analyses used in the phase 2b trial for ALLOB in order to get a better picture of the therapy’s potential efficacy.³ The changes included a reclassification of 1 of the study’s secondary end points into a primary end point and an additional interim analysis.

REFERENCES
1. BioSenic puts phase IIb ALLOB trial on hold. News release. BioSenic. June 19, 2023. Accessed June 19, 2023. https://www.biosenic.com/sites/default/files/2023-06/BIOS_PR_2023-06-19_ALLOB%20PhII%20results_EN_Final-1.pdf
2. Bone Therapeutics announces topline results from phase III knee osteoarthritis study with its enhanced viscosupplement JTA-004. News release. Bone Therapeutics. August 30, 2021. Accessed June 19, 2023. https://www.globenewswire.com/news-release/2021/08/30/2288012/0/en/Bone-Therapeutics-announces-topline-results-from-Phase-III-knee-osteoarthritis-study-with-its-enhanced-viscosupplement-JTA-004.html
3. Bone Therapeutics optimizes statistical analysis and introduces interim analysis in the ongoing ALLOB Phase IIb study for high-risk tibial fractures. News release. Bone Therapeutics. July 15, 2022. Accessed June 19, 2023. https://www.globenewswire.com/news-release/2022/07/15/2480175/0/en/Bone-Therapeutics-optimizes-statistical-analysis-and-introduces-interim-analysis-in-the-ongoing-ALLOB-Phase-IIb-study-for-high-risk-tibial-fractures.html