Robust scientific progress particularly in JTA-004 Section III examine because of excessive affected person compliance and retention
Course of growth partnership and appointment of cell remedy skilled Anthony Ting as CSO to additional strengthen product pipeline
Gosselies, Belgium, 26 Could 2021, 7am CEST – BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the cell remedy firm addressing unmet medical wants in orthopedics and different ailments, at the moment declares its enterprise replace for the primary quarter, ended 31 March 2021.
“Bone Therapeutics has continued the robust momentum into 2021,” mentioned Miguel Forte, MD, PhD, CEO of Bone Therapeutics. “Bone Therapeutics’ mid-late stage scientific applications proceed to advance largely on schedule, together with the Section IIb trial of the allogenic cell remedy platform ALLOB in difficult-to-heal tibial fractures and the Section III trial of the enhanced viscosupplement JTA-004 in knee osteoarthritic ache. Alongside this, Bone Therapeutics has strengthened its manufacturing and R&D capabilities by signing a course of growth partnership with Rigenerand. It has additionally appointed the business veteran Tony Ting as our new Chief Scientific Officer. Constructing on these achievements, Bone Therapeutics will be capable of proceed important scientific and business developments as we transfer in direction of the topline knowledge of our JTA-004 Section III examine; a possible key inflection level for Bone Therapeutics.”
- Affected person recruitment of the pivotal Section III with the improved viscosupplement JTA-004 in sufferers with knee osteoarthritis was efficiently accomplished in December 2020. Sufferers are presently being monitored in follow-up. Regardless of the consequences of the pandemic, affected person examine compliance and retention stay excessive. In consequence, Bone Therapeutics has already achieved the minimal variety of sufferers required for the evaluation of the first endpoint finishing their three month comply with up. The examine is on schedule to have high line efficacy knowledge accessible in Q3 2021 with continued monitoring till 12 months finish and full outcomes accessible in 2022. Optimistic outcomes on this examine may permit Bone Therapeutics to submit a advertising and marketing authorization utility as early as H1 2022 for the commercialization of its first product in Europe and extra territories in Asia.
- In January 2021, Bone Therapeutics initiated the therapy of sufferers within the Section IIb examine of its allogeneic cell remedy product, ALLOB, in sufferers with tough tibial fractures. Early recruitment charges have been very promising, although understandably, in March and April 2021 the speed of recruitment has slowed barely attributable to pandemic-related elements, reminiscent of lowered web site actions attributable to workers availability and variety of sufferers attributable to much less accidents. Bone Therapeutics has taken and can proceed to take motion to accentuate the recruitment by web site growth, coaching, info, greatest practices sharing and shut monitoring of progress. The preliminary results of these actions has already proven a constructive affect on affected person recruitment.
- Bone Therapeutics signed an preliminary settlement for a course of growth partnership with the mesenchymal stromal cell (MSC) specialist, Rigenerand. This primary collaboration will give attention to additional creating and enhancing Bone Therapeutics’ bone-forming cells with the potential to broaden therapeutic targets and discover new mechanisms of motion with potential gene modifications for Bone Therapeutics’ therapeutic portfolio.
- Bone Therapeutics appointed the stem cell remedy business veteran, Anthony Ting, PhD, as Chief Scientific Officer. Dr. Ting will probably be answerable for Bone Therapeutics’ analysis actions. His fast focus will probably be main the growth of Bone Therapeutics’ pipeline into new therapeutic indications, leveraging inner know-how and exterior collaborations on novel, specialised cell remedy merchandise with enhanced efficacy, utilizing differentiated and modified MSCs.
- Internet money on the finish of March 2021 amounted to €8.5 million (1).
- Disciplined price and money administration will stay a key precedence. The web money burn for the total 12 months 2021 is predicted to be within the vary of €16-17 million, assuming regular operation because the impact of the continued COVID-19 epidemic can’t be excluded. Bone Therapeutics anticipates having ample money to hold out its enterprise aims into November 2021. To additional strengthen its money place within the close to time period, the corporate is presently evaluating and dealing on completely different financing choices and plans to lift new funds with a give attention to non-dilutive funding methods.
Outlook for the rest of 2021
- Bone Therapeutics goals to report topline outcomes for the 3-month main endpoint and 6-month follow-up interval within the third quarter of 2021 for its pivotal Section III scientific examine with JTA-004.
- For the continued Section IIb ALLOB scientific examine in tough tibial fractures, Bone Therapeutics’ scientific staff, in partnership with the scientific analysis group, has instituted corrective measures to mitigate the affect of the pandemic. Given the early stage of the examine conduct and recruitment along with profitable preliminary mitigation actions, Bone Therapeutics doesn’t presently anticipate the marginally decrease recruitment price to have a cloth impact on the anticipated completion of recruitment in H1 2022 and the deliberate high line outcomes date in H2 2022.
- Bone Therapeutics will proceed to carry discussions with potential companions to discover enterprise alternatives as JTA-004 is approaching the announcement of pivotal Section III topline outcomes and ALLOB is being evaluated in a double-blind, placebo-controlled, proof-of-concept Section IIb examine.
- Bone Therapeutics will proceed its discussions with the US FDA (Meals and Drug Administration) in preparation for the following steps within the scientific growth of JTA-004 and ALLOB within the US.
- Bone Therapeutics plans to proceed to increase its allogeneic differentiated MSC primarily based cell remedy platform, past ALLOB, into different therapeutic indications.
(1) Unaudited quantity
About Bone Therapeutics
Bone Therapeutics is a number one biotech firm centered on the event of progressive merchandise to deal with excessive unmet wants in orthopedics and different ailments. The Firm has a, diversified portfolio of cell and biologic therapies at completely different levels starting from pre-clinical applications in immunomodulation to mid-to-late stage scientific growth for orthopedic circumstances, concentrating on markets with giant unmet medical wants and restricted innovation.
Bone Therapeutics is creating an off-the-shelf next-generation improved viscosupplement, JTA-004, which is presently in Section III growth for the therapy of ache in knee osteoarthritis. Consisting of a novel mixture of plasma proteins, hyaluronic acid – a pure element of knee synovial fluid, and a fast-acting analgesic, JTA-004 intends to offer added lubrication and safety to the cartilage of the arthritic joint and to alleviate osteoarthritic ache and irritation. Optimistic Section IIb efficacy leads to sufferers with knee osteoarthritis confirmed a statistically important enchancment in ache reduction in comparison with a number one viscosupplement.
Bone Therapeutics’ core expertise relies on its cutting-edge allogeneic cell remedy platform with differentiated bone marrow sourced Mesenchymal Stromal Cells (MSCs) which will be saved on the level of use within the hospital. At present in pre-clinical growth, BT-20, the newest product candidate from this expertise, targets inflammatory circumstances, whereas the main investigational medicinal product, ALLOB, represents a novel, proprietary strategy to bone regeneration, which turns undifferentiated stromal cells from wholesome donors into bone-forming cells. These cells are produced by way of the Bone Therapeutics’ scalable manufacturing course of. Following the CTA approval by regulatory authorities in Europe, the Firm has initiated affected person recruitment for the Section IIb scientific trial with ALLOB in sufferers with tough tibial fractures, utilizing its optimized manufacturing course of. ALLOB continues to be evaluated for different orthopedic indications together with spinal fusion, osteotomy, maxillofacial and dental.
Bone Therapeutics’ cell remedy merchandise are manufactured to the best GMP (Good Manufacturing Practices) requirements and are protected by a broad IP (Mental Property) portfolio masking ten patent households in addition to knowhow. The Firm relies within the BioPark in Gosselies, Belgium. Additional info is accessible at www.bonetherapeutics.com.
For additional info, please contact:
Bone Therapeutics SA
Miguel Forte, MD, PhD, Chief Government Officer
Jean-Luc Vandebroek, Chief Monetary Officer
Tel: +32 (0)71 12 10 00
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