Sturdy medical progress particularly in JTA-004 Part III research due to excessive affected person compliance and retention
Course of improvement partnership and appointment of cell remedy knowledgeable 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, right now publicizes its enterprise replace for the primary quarter, ended 31 March 2021.
“Bone Therapeutics has continued the robust momentum into 2021,” stated Miguel Forte, MD, PhD, CEO of Bone Therapeutics. “Bone Therapeutics’ mid-late stage medical packages proceed to advance largely on schedule, together with the Part IIb trial of the allogenic cell remedy platform ALLOB in difficult-to-heal tibial fractures and the Part 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 improvement partnership with Rigenerand. It has additionally appointed the trade veteran Tony Ting as our new Chief Scientific Officer. Constructing on these achievements, Bone Therapeutics will be capable of proceed important medical and industrial developments as we transfer in direction of the topline knowledge of our JTA-004 Part III research; a possible key inflection level for Bone Therapeutics.”
- Affected person recruitment of the pivotal Part 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 results of the pandemic, affected person research 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 research is on schedule to have high line efficacy knowledge out there in Q3 2021 with continued monitoring till 12 months finish and full outcomes out there in 2022. Constructive outcomes on this research may permit Bone Therapeutics to submit a advertising 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 remedy of sufferers within the Part IIb research 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 because of pandemic-related components, corresponding to lowered website actions because of employees availability and variety of sufferers because of much less accidents. Bone Therapeutics has taken and can proceed to take motion to accentuate the recruitment by website enlargement, 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 improvement 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 trade veteran, Anthony Ting, PhD, as Chief Scientific Officer. Dr. Ting will probably be accountable for Bone Therapeutics’ analysis actions. His quick focus will probably be main the enlargement of Bone Therapeutics’ pipeline into new therapeutic indications, leveraging inside know-how and exterior collaborations on novel, specialised cell remedy merchandise with enhanced efficacy, utilizing differentiated and modified MSCs.
- Web money on the finish of March 2021 amounted to €8.5 million (1).
- Disciplined price and money administration will stay a key precedence. The online 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 continuing COVID-19 epidemic can’t be excluded. Bone Therapeutics anticipates having adequate money to hold out its enterprise goals into November 2021. To additional strengthen its money place within the close to time period, the corporate is presently evaluating and dealing on totally 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 Part III medical research with JTA-004.
- For the continuing Part IIb ALLOB medical research in tough tibial fractures, Bone Therapeutics’ medical crew, in partnership with the medical analysis group, has instituted corrective measures to mitigate the affect of the pandemic. Given the early stage of the research conduct and recruitment along with profitable preliminary mitigation actions, Bone Therapeutics doesn’t right now anticipate the marginally decrease recruitment price to have a fabric 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 Part III topline outcomes and ALLOB is being evaluated in a double-blind, placebo-controlled, proof-of-concept Part IIb research.
- Bone Therapeutics will proceed its discussions with the US FDA (Meals and Drug Administration) in preparation for the subsequent steps within the medical improvement of JTA-004 and ALLOB within the US.
- Bone Therapeutics plans to proceed to develop 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 modern merchandise to deal with excessive unmet wants in orthopedics and different ailments. The Firm has a, diversified portfolio of cell and biologic therapies at totally different levels starting from pre-clinical packages in immunomodulation to mid-to-late stage medical improvement for orthopedic circumstances, focusing on markets with massive unmet medical wants and restricted innovation.
Bone Therapeutics is creating an off-the-shelf next-generation improved viscosupplement, JTA-004, which is presently in Part III improvement for the remedy of ache in knee osteoarthritis. Consisting of a singular mixture of plasma proteins, hyaluronic acid – a pure element of knee synovial fluid, and a fast-acting analgesic, JTA-004 intends to supply added lubrication and safety to the cartilage of the arthritic joint and to alleviate osteoarthritic ache and irritation. Constructive Part 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 is predicated on its cutting-edge allogeneic cell remedy platform with differentiated bone marrow sourced Mesenchymal Stromal Cells (MSCs) which may be saved on the level of use within the hospital. At present in pre-clinical improvement, BT-20, the newest product candidate from this expertise, targets inflammatory circumstances, whereas the main investigational medicinal product, ALLOB, represents a singular, proprietary strategy to bone regeneration, which turns undifferentiated stromal cells from wholesome donors into bone-forming cells. These cells are produced through 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 Part IIb medical 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 very best GMP (Good Manufacturing Practices) requirements and are protected by a broad IP (Mental Property) portfolio overlaying ten patent households in addition to knowhow. The Firm is predicated 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 Govt Officer
Jean-Luc Vandebroek, Chief Monetary Officer
Tel: +32 (0)71 12 10 00
For Belgian Media and Investor Enquiries:
Tel: +32 (0)497 75 63 56
Worldwide Media Enquiries:
Picture Field Communications
Neil Hunter / Michelle Boxall
Tel: +44 (0)20 8943 4685
firstname.lastname@example.org / email@example.com
For French Media and Investor Enquiries:
NewCap Investor Relations & Monetary Communications
Pierre Laurent, Louis-Victor Delouvrier and Arthur Rouillé
Tel: +33 (0)1 44 71 94 94
Sure statements, beliefs and opinions on this press launch are forward-looking, which replicate the Firm or, as acceptable, the Firm administrators’ present expectations and projections about future occasions. By their nature, forward-looking statements contain plenty of dangers, uncertainties and assumptions that would trigger precise outcomes or occasions to vary materially from these expressed or implied by the forward-looking statements. These dangers, uncertainties and assumptions may adversely have an effect on the result and monetary results of the plans and occasions described herein. A mess of things together with, however not restricted to, adjustments in demand, competitors and expertise, could cause precise occasions, efficiency or outcomes to vary considerably from any anticipated improvement. Ahead trying statements contained on this press launch concerning previous developments or actions shouldn’t be taken as a illustration that such developments or actions will proceed sooner or later. In consequence, the Firm expressly disclaims any obligation or enterprise to launch any replace or revisions to any forward-looking statements on this press launch on account of any change in expectations or any change in occasions, circumstances, assumptions or circumstances on which these forward-looking statements are primarily based. Neither the Firm nor its advisers or representatives nor any of its subsidiary undertakings or any such particular person’s officers or workers ensures that the assumptions underlying such forward-looking statements are free from errors nor does both settle for any duty for the longer term accuracy of the forward-looking statements contained on this press launch or the precise prevalence of the forecasted developments. You shouldn’t place undue reliance on forward-looking statements, which converse solely as of the date of this press launch.