hyaluronic acid (JTA-004) / BioSenic - LARVOL DELTA

A SINGLE INTRA-ARTICULAR INJECTION OF JTA-004 IS SAFE AND EFFICIENT FOR TREATING SYMPTOMS IN THE MOST SEVERELY AFFECTED KNEE OSTEOARTHRITIS PATIENTS – A POST HOC ANALYSIS OF MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-AND ACTIVE-TREATMENT CONTROLLED PHASE III KOA-2 CLINICAL TRIAL (EULAR 2024) - "Objectives: To investigate the effects of JTA-004, an innovative intra-articular treatment for knee osteoarthritis (OA) composed of hyaluronic acid, plasmatic proteins, and clonidine, on symptoms of subgroups of patients with knee OA and to compare these effects with those of saline solution and Synvisc-one®. A single intra-articular injection of JTA-004 is safe and efficient for treating symptoms of the most severely affected knee OA patients or with high levels of systemic inflammation, which represent a frequent endotype of synovial-driven OA. JTA-004 needs to be re-tested with a focus on patients with inflammatory and painful knee OA. Figure 1."

Clinical • P3 data • Retrospective data • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology • CRP

A SINGLE INTRA-ARTICULAR INJECTION OF JTA-004 IS SAFE AND EFFICIENT FOR TREATING SYMPTOMS IN THE MOST SEVERELY AFFECTED KNEE OSTEOARTHRITIS PATIENTS – A MULTICENTER, RANDOMIZED, DOUBLE-BLING, PLACEBO AND ACTIVE TREATMENT CONTROLLED PHASE III CLINICAL TRIAL. (OARSI 2024) - "Purpose (the aim of the study): JTA-004 is an innovative intra-articular treatment for knee osteoarthritis (OA), composed of hyaluronic acid, plasmatic proteins, and clonidine. The goal of this Phase III clinical trial was to demonstrate that treatment with JTA-004 leads to a reduction in knee pain intensity compared to saline solution, three months after injection, in subjects suffering from symptomatic knee OA."

Clinical • P3 data • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

BioSenic presents new Phase 3 data on JTA-004 to treat severe osteoarthritis pain at the 2024 OARSI World Congress (GlobeNewswire) - P3 | N=746 | NCT04333160 | Sponsor: Bone Therapeutics S.A | "BioSenic...will for the first time share post hoc data on its late-clinical asset JTA-004 at the Osteoarthritis Research Society International (OARSI) World Congress 2024. The post hoc analysis of a Phase 3 study found that a single injection of JTA-004 was safe and efficacious for patients with a newly characterized severe inflammatory subtype of knee osteoarthritis (OA). The data will be presented by Yves Henrotin, Ph.D, a professor at University of Liège in Belgium (musculoSKeletal Innovative research Lab, mSKIL), Center for Interdisciplinary Research on Medicine, CIRM), as well as Founder and the Chairman of the Board of Artialis, which performed the analysis."

P3 data • Retrospective data • CNS Disorders • Osteoarthritis • Pain

BioSenic files for additional patent protection following new clinical evidence of efficacy for JTA-004 in osteoarthritis (GlobeNewswire) - "BioSenic...announces the filing of a U.S. patent for JTA-004, a viscosupplement in late-stage clinical development, following new evidence of its efficacy in a recently defined subtype of osteoarthritis (OA)."

Patent • Osteoarthritis • Pain

BioSenic reacquires global IP rights and provides update on JTA-004 development (GlobeNewswire) - "BioSenic...announces an update to its future plans for clinical development of BioSenic’s enhanced viscosupplement JTA. This includes BioSenic reacquiring intellectual property rights for the therapy....This new in-depth analysis now enables BioSenic to recall the intellectual property rights to JTA, which were transferred to the Walloon Region in Belgium, with the reset of the initial financial agreement between both parties. BioSenic is already looking for an industry partner to submit its results to the regulatory bodies in order to find the best and fastest way to obtain a Marketing Authorization (MA). This partnership will jointly conduct a small-scale additional Phase III trial targeting the most severe form of knee OA, prior to the MA with global regulators. The Marketing Authorization Application (MAA) could be submitted as soon as three years after the start of the Phase III trial, and as a result JTA could reach the market in 2027."

European regulatory • Licensing / partnership • New P3 trial • CNS Disorders • Osteoarthritis • Pain

BioSenic delivers a new post-hoc analysis of its Phase III JTA-004 trial on knee osteo-arthritis with positive action on the most severely affected patient population (GlobeNewswire) - P3 | N=746 | NCT04333160 | Sponsor: Bone Therapeutics S.A | "BIOSENIC...announces today it has re-evaluated the results of its Phase III trial of its enhanced viscosupplement JTA-004 targeting knee osteoarthritis (OA). BioSenic has obtained new statistical analysis results from the JTA-004 Phase III clinical trial data, released in August 2021. The multicenter, randomized, double blind, placebo- and active-controlled Phase III study was conducted in 7 European countries and Hong Kong and included a total of 743 patients. The study did not meet the primary and consequently the key secondary endpoints, despite JTA-004’s favorable safety profile."

P3 data • CNS Disorders • Osteoarthritis • Pain

Hyaluronic Acid Knee Injections Equivalent to Placebo (RheumNow) - "Viscosupplementation appears to be capable of minimal (nonsignificant) reduction in knee OA pain and minimal (but significant) risk of serious adverse events compared with placebo. Most international guidelines currently discourage the use of intra-articular hyaluronic acid derivatives in treating knee OA."

Online posting

JTA-KOA2: Phase III Study on the Safety and Efficacy of a Single Intra-articular Administration of JTA-004 in Symptomatic Knee Osteoarthritis (clinicaltrials.gov) - P3 | N=746 | Completed | Sponsor: Bone Therapeutics S.A | Active, not recruiting ➔ Completed

Trial completion • Immunology • Osteoarthritis • Pain • Rheumatology

Safety and efficacy of a single intra-articular injection of a novel enhanced protein solution (JTA-004) compared to hylan G-F 20 in symptomatic knee osteoarthritis: a randomized, double-blind, controlled phase II/III study. (PubMed, BMC Musculoskelet Disord) - P2/3 | "This study provided preliminary evidence of the safety of intra-articular injection of JTA-004 in knee osteoarthritis patients. Phase III randomized controlled trials with larger sample sizes are needed to evaluate the efficacy of JTA-004 in knee osteoarthritis."

Clinical • Journal • P2 data • P2/3 data • Immunology • Orthopedics • Osteoarthritis • Pain • Rheumatology

Bone Therapeutics' lead program falls short in knee osteoarthritis (FierceBiotech) - "Bone Therapeutics is mulling options for its lead program after the osteoarthritis treatment flopped in a phase 3 study...The company's stock dipped 33% Monday morning from its closing price of €2.66 on Friday."

Commercial • CNS Disorders • Osteoarthritis • Pain

Bone Therapeutics announces topline results from Phase III knee osteoarthritis study with its enhanced viscosupplement JTA-004 (GlobeNewswire) - P3, N=120; NCT04333160; Sponsor: Bone Therapeutics S.A; "BONE THERAPEUTICS...announces that the Phase III knee osteoarthritis study with its enhanced viscosupplement JTA-004 did not meet the primary and consequently the key secondary endpoints....The primary objective of the JTA-004 Phase III study was to demonstrate the efficacy of JTA-004 in reducing osteoarthritic knee pain compared to placebo as measured by the WOMAC® pain subscale three months after treatment....A statistically significant difference in favor of JTA-004 and the active comparator versus placebo was seen in a post-hoc analysis in a subset of patients with higher pain scores at entry."

P3 data: top line • CNS Disorders • Osteoarthritis • Pain

Bone Therapeutics provides update on the progress of clinical studies (GlobeNewswire) - "These studies are the pivotal Phase III clinical trial with Bone Therapeutics’ enhanced viscosupplement, JTA-004, targeting osteoarthritic knee pain...Bone Therapeutics expects to report topline results for the 3-month primary endpoint and 6-month follow-up data in the first half of September 2021....The study is being conducted in 22 centers across six European countries as well as Hong Kong."

P3 data: top line • CNS Disorders • Osteoarthritis • Pain

Bone Therapeutics secures up to €16 million loan financing from the European Investment Bank to accelerate ongoing clinical and commercial development of innovative orthopedic treatment (GlobeNewswire) - "BONE THERAPEUTICS...announces that it has signed a loan agreement of up to €16 million with the European Investment Bank (EIB)....The EIB financing will support and prepare Bone Therapeutics’ lead asset, the enhanced viscosupplement JTA-004 for future regulatory approval and commercialization. JTA-004, is being evaluated in a registrational phase III clinical trial for the treatment of osteoarthritic pain in the knee...Bone Therapeutics plans to submit a marketing authorization application to European regulatory authorities in the first half of 2022."

European regulatory • Financing • Osteoarthritis • Pain

[VIRTUAL] Bone Therapeutics (BIO 2021) - "Leveraging its extensive expertise in mesenchymal stromal cells (MSCs), bone physiology and patented manufacturing technology, Bone Therapeutics is developing a commercially ready, allogeneic and off-the-shelf bone cell therapy platform, ALLOB, and a next-generation improved viscosupplement for osteoarthritic pain, JTA-004, which are designed to offer patients and physicians best-in-class treatment options. Currently in Phase II-III clinical development, Bone Therapeutics’ advanced product portfolio targets large orthopaedic conditions with high unmet needs, such as knee osteoarthritis, unhealed fractures and spinal fusion. Building on its allogeneic MSC platform, Bone Therapeutics recently broadens the product portfolio from orthopedics into inflammatory and other conditions."

Immunology • Musculoskeletal Diseases • Orthopedics • Osteoarthritis • Pain • Rheumatology

Bone Therapeutics announces 2020 full year results (GlobeNewswire) - "Received in total €1.6 million in grants and non-dilutive funding from the Walloon Region, Belgium, to advance Phase III clinical study with JTA-004 as well as for research and preparation of clinical development of BT-20...Bone Therapeutics aims to report topline results for the 3-month primary endpoint and 6-month follow-up period in the third quarter of 2021 for its pivotal Phase III clinical study with the improved viscosupplement, JTA-004, in patients with knee osteoarthritis....Bone Therapeutics will continue its discussions with the US FDA (Food and Drug Administration) in preparation for the next steps in the clinical development of JTA-004...in the US."

Financing • P3 data: top line • CNS Disorders • Osteoarthritis • Pain

Bone Therapeutics completes recruitment and patient treatment in JTA-004 pivotal Phase III knee osteoarthritis study (GlobeNewswire) - "BONE THERAPEUTICS...today announces it has completed recruitment and treated all patients in its pivotal Phase III clinical study with the improved viscosupplement, JTA-004, in patients with knee osteoarthritis. Topline results are anticipated on the 3-month primary endpoint and 6-month follow-up period in the third quarter of 2021."

Enrollment closed • P3 data: top line • CNS Disorders • Osteoarthritis • Pain

JTA-KOA2: Phase III Study on the Safety and Efficacy of a Single Intra-articular Administration of JTA-004 in Symptomatic Knee Osteoarthritis (clinicaltrials.gov) - P3; N=742; Active, not recruiting; Sponsor: Bone Therapeutics S.A; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Immunology • Osteoarthritis • Pain • Rheumatology

Bone Therapeutics announces pricing of private placement (GlobeNewswire) - "BONE THERAPEUTICS SA...today announces that it has entered into subscription agreements with investors to purchase up to 4,408,881 new shares at an issue price of EUR 2.25 per share resulting in gross proceeds of approximately EUR 10 million...Bone Therapeutics intends to use the net proceeds from the Private Placement to: complete the Phase III clinical trial of its next generation intra-articular injectable JTA-004 for the treatment of patients with osteoarthritic pain in the knee. The study is currently conducted in Europe and Hong Kong. It will also prepare for a clinical study in the United States....With the total gross proceeds raised through the Private Placement, Bone Therapeutics expects to have sufficient cash to carry out its strategic objectives until end Q4 2021."

Financing • CNS Disorders • Osteoarthritis • Pain

Bone Therapeutics Provides Third Quarter 2020 Business Update (GlobeNewswire) - "Since the initiation of the recruitment in mid-May 2020, Bone Therapeutics has completed now over 60% of the patient recruitment in the ongoing Phase III clinical study with the improved viscosupplement, JTA-004, in patients with knee osteoarthritis....Bone Therapeutics expects to complete patient enrollment in the Phase III JTA-004 study before year-end....In November, Bone Therapeutics plans to initiate discussions with the US FDA (Food and Drug Administration) in preparation for the next steps in the clinical development of JTA-004 in the US, a large, important market."

Enrollment status • Regulatory • CNS Disorders • Osteoarthritis • Pain

Bone Therapeutics reaches 50% treated patients in ongoing JTA-004 Phase III pivotal knee osteoarthritis study (GlobeNewswire) - "BONE THERAPEUTICS...today announces it has already completed over 50% of its treated patients in its Phase III clinical study with the improved viscosupplement, JTA-004, in patients with knee osteoarthritis....Bone Therapeutics expects to complete patient enrollment before year-end. Topline results are anticipated on the 3-month primary endpoint and 6-month follow-up period in the second half of 2021....The study plans to enroll 676 patients fulfilling the protocol criteria with mild to moderate symptomatic knee osteoarthritis."

Enrollment status • P3 data: top line • CNS Disorders • Immunology • Osteoarthritis • Pain

Bone Therapeutics will consume between 15 and 16 million euros of cash this year [Google translation] (Investir - Les Echos) - "The pivotal phase III clinical trial JTA-004 in osteoarthritis of the knee is ongoing....The recruitment of patients for phase III of the JTA004 study should be finalized before the end of the year and the biotech expects to present its main results in the second half of 2021. In the meantime, net cash consumption in 2020 is expected to reach 15 to 16 million euros this year. The company's funds will therefore not be sufficient to hold out until the announcement of these results."

Financing • P3 data • Osteoarthritis • Pain

Bone Therapeutics to complete recruitment for knee pain trial by year-end (Proactiveinvestors) - "Bone Therapeutics...said it expects patient recruitment for the phase III trial of osteoarthritic knee pain treatment, JTA-004, to be completed by the 2020 year-end. The Euronext-listed biotech added it also expects to start recruitment soon for a phase IIb study of ALLOB for difficult tibial fractures as regulatory approvals are nearly all complete."

Enrollment status • Osteoarthritis • Pain

Bone Therapeutics reports half year 2020 results (GlobeNewswire) - "In November, Bone Therapeutics plans to initiate the first discussions with the US FDA (Food and Drug Administration) in preparation for the next steps in the clinical development of JTA-004 in the US, a large, important market."

FDA event • CNS Disorders • Osteoarthritis • Pain

Bone Therapeutics receives EUR 1.0 million to advance ongoing JTA-004 phase III knee osteoarthritis study (GlobeNewswire) - "BONE THERAPEUTICS...today announces it has been granted EUR 1.0 million...This funding will provide further financial support...to advance its current pivotal phase III clinical study with the enriched protein solution, JTA-004....Since the initiation of the trial in mid-May 2020, 164 patients have already been treated, roughly 20% of the targeted assessable patients....Bone Therapeutics expects to complete patient enrollment before year-end and anticipates reporting topline results on the 3-month primary endpoint and 6-month follow-up period in the second half of 2021."

Enrollment status • Financing • P3 data: top line • CNS Disorders • Osteoarthritis • Pain

EULAR Guidelines On Injection Of Platelet Rich Plasma In Knee Osteoarthritis (Medical Dialogues) - "European League Against Rheumatism has presented an expert consensus on the first clinical practice recommendations for platelet-rich plasma (PRP) injections in knee osteoarthritis at the European Congress of Rheumatology (EULAR) annual meeting."

Clinical guideline • Osteoarthritis • Pain