Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GP2017 · 1 trial · 1 indication
Radiographic progression was based on scores from the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS). The mSASSS is the sum of scores assessing the vertebral corners of the lumbar and cervical spine as 0 (normal), 1 (erosion, sclerosis, or squaring), 2 (syndesmophyte), or 3 (bridging syndesmophyte) with a total range from 0-72. No radiographic progression was defined as the change from baseline in mSASSS score \<= 0.5.
| Arm | Type | Description |
|---|---|---|
| AIN457 150 mg/placebo | EXPERIMENTAL | AIN457 150 mg and a matching placebo was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 100 |
| AIN457 300 mg | EXPERIMENTAL | AIN457 300 mg (2 x 150 mg) was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 100 |
| GP2017 40mg | ACTIVE_COMPARATOR | GP2017 (adalimumab biosimilar) 40 mg was administered subcutaneously via pre-filled syringes at Baseline followed by dosing every 2 weeks until Week 102 |
| Name | Type | Description |
|---|---|---|
| Placebo | BIOLOGICAL | Matching placebo to AIN457 150 mg dose administered with AIN457 via pre-filled syringes |
| GP2017 (adalimumab biosimilar) | BIOLOGICAL | 40 mg in pre-filled syringes was administered subcutaneously |
| AIN457 150 mg | BIOLOGICAL | 150 mg in pre-filled syringes was administered subcutaneously |
Inclusion Criteria: * Male or non-pregnant, non-nursing female patients at least 18 years of age * Diagnosis of moderate to severe Ankylosing Spondylitis with radiologic evidence (centrally read X-ray) fulfilling the Modified New York criteria for AS despite previous or current NSAID/ nonbiologic D...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 1 | PHASE2 | Tulisokibart |
| Spyre Therapeutics, Inc | SYRE | 1 | PHASE2 | SPY002-072 |
| XBiotech, Inc. | XBIT | 1 | PHASE2 | vilamakitug |
| Sunshine Biopharma Incorporated | SBFM | 2 | PHASE3 | Undisclosed |
| AbbVie, Inc. | ABBV | 1 | - | Upadacitinib |
| Novartis AG Sponsored ADR | NVS | 1 | - | Secukinumab |
| Pfizer Inc. | PFE | 1 | - | Tofacitinib |
| TScan Therapeutics, Inc. | TCRX | 1 | - | Undisclosed |
GP2017 is an investigational monoclonal antibody being studied for the treatment of ankylosing spondylitis, a form of arthritis that primarily affects the spine. It is being evaluated in a Phase 3 clinical trial as a comparator against secukinumab to assess its effect on radiographic progression in patients with this condition.
GP2017 is a monoclonal antibody that targets tumor necrosis factor alpha (TNF-alpha), a key inflammatory cytokine involved in the pathogenesis of ankylosing spondylitis. By binding to TNF-alpha, GP2017 is designed to block its pro-inflammatory activity, potentially reducing disease activity and preventing structural damage in affected patients.
GP2017 is being developed by Novartis AG, a global pharmaceutical company headquartered in Basel, Switzerland. Novartis trades on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical trials to evaluate the safety and efficacy of GP2017 in patients with ankylosing spondylitis.
GP2017 is currently in Phase 3 clinical development. It has completed one Phase 3 trial, which was an active-controlled study comparing its effect on radiographic progression in ankylosing spondylitis to that of secukinumab. The drug remains investigational and has not yet been approved by regulatory authorities.
GP2017 has been studied in one completed Phase 3 clinical trial with the identifier NCT03259074. This trial, titled 'Effect of Secukinumab on Radiographic Progression in Ankylosing Spondylitis as Compared to GP2017 (Adalimumab Biosimilar)', enrolled 859 participants across multiple countries including the United States, Argentina, Australia, and Japan.
GP2017 is an adalimumab biosimilar, meaning it is designed to be highly similar to the reference biologic adalimumab (brand name Humira). However, GP2017 is a distinct product developed by Novartis and is being evaluated as a potential biosimilar for the treatment of ankylosing spondylitis.