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New data show TREMFYA® (guselkumab) is the only IL-23 inhibitor proven to significantly inhibit progression of joint structural damage in active psoriatic arthritis
Prnewswire· 2025-06-11 12:05
Core Insights - TREMFYA® (guselkumab) demonstrated significant efficacy in inhibiting joint structural damage and improving symptoms in patients with active psoriatic arthritis (PsA) in the Phase 3b APEX study [1][2][3] Efficacy Results - TREMFYA® showed a 2.5 times greater ability to inhibit joint structural damage compared to placebo [1] - At Week 24, 67% of patients receiving TREMFYA® every four weeks (Q4W) and 63% every eight weeks (Q8W) experienced no radiographic progression, compared to 53% in the placebo group [2] - More than 40% of TREMFYA®-treated patients achieved ACR50 response at Week 24, significantly higher than the 20% in the placebo group [1][5] Safety Profile - The safety profile of TREMFYA® remained consistent with previous studies, with no new safety signals identified [3] - TREMFYA® is the first and only fully-human, dual-acting monoclonal antibody approved for treating PsA, targeting IL-23 and binding to CD64 [3][9] Study Design - The APEX study was a multicenter, randomized, double-blind, placebo-controlled trial involving biologic-naïve patients with active PsA who had inadequate responses to standard therapies [7] Market Position - Johnson & Johnson maintains exclusive worldwide marketing rights to TREMFYA®, which is approved in multiple regions for treating moderate-to-severe plaque psoriasis and active PsA [10][24]
AnaptysBio: Positive RA Data Bodes Well For Continued Rosnilimab Advancement
Seeking Alpha· 2025-06-06 19:39
Group 1 - AnaptysBio, Inc. (NASDAQ: ANAB) reported positive results from its phase 2b study for a PD-1 depleter and agonist drug aimed at treating moderate-to-severe rheumatoid arthritis (RA) [2] - The study's results indicate potential for the drug to address significant unmet medical needs in the RA patient population [2] Group 2 - The Biotech Analysis Central service offers in-depth analysis of pharmaceutical companies, including a library of over 600 biotech investing articles and a model portfolio of small and mid-cap stocks [2]
AnaptysBio's Arthritis Drug Matches Top Therapies In Phase 2 Trial, Analyst Sees Turning Point
Benzinga· 2025-06-04 18:23
Core Insights - AnaptysBio, Inc. has released updated data from the Phase 2b trial of rosnilimab, demonstrating significant efficacy in treating rheumatoid arthritis [1][2] - The drug showed durable responses and was well tolerated compared to standard biologics and JAK inhibitors [2][4] - Analyst Emily Bodnar upgraded AnaptysBio's rating from Neutral to Buy, raising the price target from $22 to $38 based on positive trial data [4] Efficacy and Safety - In a 424-patient trial, rosnilimab achieved JAK-like efficacy on multiple measures, including low disease activity (LDA) and remission on the Clinical Disease Activity Index (CDAI) [1] - At Week 12, all three doses of rosnilimab (100mg Q4W, 400mg Q4W, 600mg Q2W) showed statistically significant reductions in DAS-28 CRP and ACR20 compared to placebo [2] - By Week 12, 45% of patients achieved CDAI LDA, increasing to 69% by Week 14 across all doses [2] Patient Outcomes - Rosnilimab demonstrated clinically meaningful improvements in patient-reported outcomes, including pain visual analog scale (VAS) and HAQ-Disability Index [4] - As of the March 11, 2025 data cutoff, 83% of patients remained in LDA at Week 34, with a median CDAI of 13 for those not sustaining LDA [3] Competitive Landscape - Data from the SELECT-CHOICE trial indicated similar efficacy results for AbbVie’s Rinvoq and Bristol Myers Squibb’s Orencia, aligning with rosnilimab's outcomes [5] - In contrast, Eli Lilly's discontinued PD-1 agonist peresolimab showed a decline in CDAI LDA rates, highlighting rosnilimab's stronger performance [6] - Johnson & Johnson is expected to present early data for its PD-1 agonist at the upcoming EULAR conference, although its study is smaller than AnaptysBio's [6]
Incannex Healthcare Inc. Reports Fiscal Third Quarter 2025 Financial Results and Business Updates
GlobeNewswire News Room· 2025-05-15 12:00
Core Viewpoint - Incannex Healthcare Inc. is making significant progress in its IHL-42X development program for treating obstructive sleep apnea (OSA), with key milestones expected in the near future [2]. Operational Highlights - The company secured $12.5 million in private placement funding to support the ongoing IHL-42X Phase 2/3 clinical program [7]. - An OSA Clinical Advisory Board was formed, with Dr. Alison Wimms appointed to enhance collaboration and clinical development efforts [7]. - More than 120 patients have been dosed across 11 clinical trial sites in the Phase 2 portion of the RePOSA study [7]. Clinical Highlights - IHL-42X is an oral fixed-dose combination of dronabinol and acetazolamide, currently in the RePOSA Phase 2/3 clinical trial, which aims to enroll over 560 patients globally [6]. - The trial is evaluating two doses of IHL-42X compared to placebo over a four-week treatment period, with topline data expected in July 2025 [7][8]. - Positive topline results from a pharmacokinetics and safety study confirmed the bioavailability of both active components in IHL-42X [7]. Financial Results - General and Administrative (G&A) expenses for the three months ended March 31, 2025, were $2.27 million, down from $4.14 million in the same period of 2024 [7]. - Research and Development (R&D) expenses for the same period totaled $2.74 million, compared to $3.28 million in 2024 [7]. - The net loss for the three-month period ended March 31, 2025, was $3.97 million, a decrease from $6.03 million in the prior year [7].
The Joint Chiropractic Observes National Arthritis Awareness Month in May
Prnewswire· 2025-05-02 12:48
– How Chiropractic Care Can Help Ease Joint Pain and Improve Mobility –SCOTTSDALE, Ariz., May 2, 2025 /PRNewswire/ -- According to the CDC, arthritis affects more than 50 million Americans, and nearly 26 million of those with arthritis are unable to do everyday activities. The Joint Corp. (NASDAQ: JYNT), the nation's largest franchisor of chiropractic care through The Joint Chiropractic® network, is encouraging patients to consider natural ways to support long-term joint health.Arthritis is one of the most ...