Aclaris 
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  • ||||||||||  ATI-2231 / Aclaris
    Enrollment change, Trial withdrawal:  ATI-2231 in Advanced Solid Tumor Malignancies (clinicaltrials.gov) -  Nov 29, 2023   
    P1,  N=0, Withdrawn, 
    Phase classification: P2a --> P2 N=36 --> 0 | Suspended --> Withdrawn
  • ||||||||||  ATI-2231 / Aclaris
    Trial suspension, Metastases:  ATI-2231 in Advanced Solid Tumor Malignancies (clinicaltrials.gov) -  Nov 19, 2023   
    P1,  N=36, Suspended, 
    N=36 --> 0 | Suspended --> Withdrawn Not yet recruiting --> Suspended
  • ||||||||||  ATI-50001 / Aclaris, Rigel
    Journal:  3D Resin-coated pressure sensor response for bite force assessment: A pilot study. (Pubmed Central) -  Aug 31, 2023   
    In this preliminary study, the evaluated sensor (FlexiForce A201 Sensor, Tekscan) was firstly calibrated without any type of cover material, and later tested with 3D printing resin with different thicknesses (1 mm, 1.15 mm, 1.4 mm and 1.6 mm)...When the pressure sensor was covered with resin of 1mm and 1.6 mm thick specimens, a higher difference was found between the applied load and the corresponding sensor reading. It was concluded that it is possible to use this type of pressure sensor and that it showed better accuracy with the 1.15 mm and 1.4 mm 3D printing resin covering.
  • ||||||||||  zunsemetinib (ATI-450) / Aclaris
    Loss of MAPKAPK2 Enhances cGAS-STING-IFN (Room 8) -  Aug 22, 2023 - Abstract #ASTRO2023ASTRO_1821;    
    Selected drug studies using the MK2 inhibitor, ATI-450, were performed with RT... HNSCC tumor MK2 inhibition enhances RT-mediated micronuclei formation and subsequent cGAS-STING-IFN
  • ||||||||||  Litfulo (ritlecitinib) / Pfizer, Olumiant (baricitinib) / Incyte, Eli Lilly, ifidancitinib (ATI-502) / Aclaris, Rigel
    Review, Journal:  Which is the Ideal JAK Inhibitor for Alopecia Areata - Baricitinib, Tofacitinib, Ritlecitinib or Ifidancitinib - Revisiting the Immunomechanisms of the JAK Pathway. (Pubmed Central) -  Jul 31, 2023   
    Moreover, the response achieved with JAKibs is not sustained after treatment discontinuation, with many studies showing a high recurrence rate with tofacitinib and ruxolitinib post-treatment...Thus, JAK3ibs may be associated with a better side effect profile and, in conjunction with their specificity, may replace other JAKibs as the treatment of choice for AA. We herein discuss the role of the JAK/STAT (signal transducer and activator of transcription) pathway in AA, the intricacies of various JAKibs in the management of AA, and emphasize the need for studies on tissue JAK and cytokine expression before arriving at the ideal JAKibs for AA.
  • ||||||||||  zunsemetinib (ATI-450) / Aclaris
    Enrollment closed:  ATI-450 Plus MTX Versus Placebo Plus MTX in Patients With Moderate to Severe Active RA (clinicaltrials.gov) -  Jul 13, 2023   
    P2,  N=251, Active, not recruiting, 
    We herein discuss the role of the JAK/STAT (signal transducer and activator of transcription) pathway in AA, the intricacies of various JAKibs in the management of AA, and emphasize the need for studies on tissue JAK and cytokine expression before arriving at the ideal JAKibs for AA. Recruiting --> Active, not recruiting
  • ||||||||||  ATI-2231 / Aclaris
    Phase classification, Enrollment change, Trial completion date, Trial primary completion date, Metastases:  ATI-2231 in Advanced Solid Tumor Malignancies (clinicaltrials.gov) -  Apr 26, 2023   
    P1,  N=36, Not yet recruiting, 
    Not yet recruiting --> Recruiting Phase classification: P1/2 --> P1 | N=174 --> 36 | Trial completion date: Oct 2030 --> Feb 2025 | Trial primary completion date: Oct 2030 --> Feb 2025
  • ||||||||||  ATI-1777 / Aclaris
    Trial completion date, Trial primary completion date:  Study of ATI-1777 in Patients 12 to 65 Years Old With Mild to Severe Atopic Dermatitis (clinicaltrials.gov) -  Apr 25, 2023   
    P2b,  N=240, Recruiting, 
    Phase classification: P1/2 --> P1 | N=174 --> 36 | Trial completion date: Oct 2030 --> Feb 2025 | Trial primary completion date: Oct 2030 --> Feb 2025 Trial completion date: Apr 2023 --> Oct 2023 | Trial primary completion date: Mar 2023 --> Sep 2023
  • ||||||||||  zunsemetinib (ATI-450) / Aclaris
    Trial completion date, Trial primary completion date:  ATI-450 Plus MTX Versus Placebo Plus MTX in Patients With Moderate to Severe Active RA (clinicaltrials.gov) -  Apr 13, 2023   
    P2,  N=240, Recruiting, 
    Trial completion date: Apr 2023 --> Oct 2023 | Trial primary completion date: Mar 2023 --> Sep 2023 Trial completion date: May 2023 --> Sep 2023 | Trial primary completion date: Apr 2023 --> Aug 2023
  • ||||||||||  ATI-2231 / Aclaris
    New P1 trial, New P1/2 trial, Combination therapy, Metastases:  ATI-2231 in Advanced Solid Tumor Malignancies (clinicaltrials.gov) -  Mar 30, 2023   
    P1/2,  N=174, Not yet recruiting, 
  • ||||||||||  zunsemetinib (ATI-450) / Aclaris, ulixertinib (BVD-523) / BioMed Valley Discoveries
    TNF-MK2 signaling drives protective autophagy following MAPK pathway inhibition in pancreatic cancer (Section 15; Poster Board #20) -  Mar 14, 2023 - Abstract #AACR2023AACR_6095;    
    The combination of MK2 inhibitor ATI-450 and ERK inhibitor ulixertinib was more effective in curbing the growth of PDAC patient-derived xenograft in vivo and prolonged the survival of autochthonous PDAC mice (KPC model). Overall, our study provided novel insights on the mechanisms that drive protective autophagy following MAPK pathway inhibition and a rationale and feasible therapeutic combination that can be tested in clinical trials for PDAC patients.
  • ||||||||||  zunsemetinib (ATI-450) / Aclaris
    Clinical, P2a data, Journal:  Selective Inhibition of the MK2 Pathway: Data From a Phase IIa Randomized Clinical Trial in Rheumatoid Arthritis. (Pubmed Central) -  Jan 7, 2023   
    This is the first clinical study demonstrating that selective mitogen-activated protein kinase (MAPK)-activated protein kinase 2 (MK2) pathway blockade leads to a sustained antiinflammatory effect. This suggests that targeting the MK2 pathway mitigates the tachyphylaxis observed with p38 MAPK inhibitors in RA and supports further exploration.
  • ||||||||||  ATI-50001 / Aclaris, Rigel
    Journal:  Diastolic versus Systolic Left Ventricular Dysfunction as Independent Predictors for Unfavorable Postoperative Evolution in Patients with Aortic Regurgitation Undergoing Aortic Valve Replacement. (Pubmed Central) -  Nov 25, 2022   
    Materials and We performed a prospective study enrolling 332 AR patients undergoing AVR, divided into two groups: Group A-201 pts with normal LV systolic function, divided into two subgroups (A1: 129 pts with a nonrestrictive LVDFP and A2: 72 pts with restrictive LVDFP), and Group B-131 pts with LV systolic dysfunction (LV ejection fraction LVEF < 50%), divided into two subgroups (B1: 83 pts with a nonrestrictive LVDFP and B2: 48 pts with restrictive LVDFP)...The LV diastolic function is a more reliable parameter for prognosis than LV systolic performance (RR 9.2 versus 2.1). Other independent predictors for increased early postoperative mortality rate were: an age > 75 years, an LVESD > 58 mm, and comorbidities (diabetes mellitus, COPD), and for unfavorable evolution at 2 years postoperatively: an age > 75 years, an LVESV > 95 cm, and severe pulmonary hypertension.
  • ||||||||||  ifidancitinib (ATI-502) / Aclaris, Rigel
    Journal, PD(L)-1 Biomarker, IO biomarker:  Induction of T cell exhaustion by JAK1/3 inhibition in the treatment of alopecia areata. (Pubmed Central) -  Oct 14, 2022   
    Ifidancitinib is a potent and selective next-generation JAK1/3 inhibitor predicted to disrupt γc cytokine signaling...Furthermore, we found that γc cytokines regulated T cell exhaustion. Taken together, our data indicate that selective induction of T cell exhaustion using a JAK inhibitor may offer a mechanistic explanation for the success of this treatment strategy in the reversal of autoimmune diseases such as AA.
  • ||||||||||  ATI-50001 / Aclaris, Rigel
    Journal:  HapticLink: A Force-based Haptic Feedback System for Single and Double Lower-Limb Amputees. (Pubmed Central) -  Sep 18, 2022   
    The FlexiForce A201 sensors were identified as the optimal choice for the parameters and scenarios investigated...94.44, 79.17%, and 100%) and responses from the participants indicating that HapticLink may aid during single or double lower-limb amputee ambulation after establishing haptic feedback intensity comfort. Finally, the successful qualitative tests with a double lower-limb amputee imply the haptic feedback may be sufficient without requiring sensor fusion on the part of the participant from both the VMs and the proprioception of the contralateral leg. Clinical Relevance--- This establishes the utility of a simple, stand-alone 4:4 force sensor and haptic motor feedback system to aid during single or double lower-limb amputee ambulation.
  • ||||||||||  zunsemetinib (ATI-450) / Aclaris
    A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Zunsemetinib, an Investigational Oral MK2 Inhibitor, at 80 Mg and 120 Mg Twice Daily Dose Levels in Healthy Subjects (Virtual Poster Hall) -  Sep 17, 2022 - Abstract #ACRConvergence2022ACR_CONVERGENCE_1584;    
    Finally, the successful qualitative tests with a double lower-limb amputee imply the haptic feedback may be sufficient without requiring sensor fusion on the part of the participant from both the VMs and the proprioception of the contralateral leg. Clinical Relevance--- This establishes the utility of a simple, stand-alone 4:4 force sensor and haptic motor feedback system to aid during single or double lower-limb amputee ambulation. Multiple oral doses of zunsemetinib (up to 120 mg BID) administered to healthy subjects in this study were generally safe and well tolerated.The exposure was dose proportional over the full dose range tested (10 – 120 mg) following 7 days of BID dosing
  • ||||||||||  irinotecan / Generic mfg.
    Journal:  The MK2/Hsp27 axis is a major survival mechanism for pancreatic ductal adenocarcinoma under genotoxic stress. (Pubmed Central) -  Mar 31, 2022   
    Multiple oral doses of zunsemetinib (up to 120 mg BID) administered to healthy subjects in this study were generally safe and well tolerated.The exposure was dose proportional over the full dose range tested (10 – 120 mg) following 7 days of BID dosing In this study, we aimed to identify and characterize resistance mechanisms to a FIRINOX chemotherapy regimen (a combination of 5-fluorouracil, irinotecan, and oxaliplatin) because it is the most aggressive regimen currently used clinically for patients with PDAC...In an autochthonous PDAC mouse model, the MK2 inhibitor ATI-450 decreased PDAC development and progression...[Figure: see text].
  • ||||||||||  zunsemetinib (ATI-450) / Aclaris
    A Trial of MK2 Inhibitor ATI-450 in Patients with Moderate-Severe Novel Coronavirus Disease 2019 (COVID-19) (Area J, Hall F (North Building, Exhibition Level), Moscone Center) -  Feb 19, 2022 - Abstract #ATS2022ATS_3080;    
    Blood drawn at baseline and end of treatment demonstrated relative reductions in IL-6, IL-8, TNFα, and G-CSF in the ATI-450 arm compared to placebo (discussed in a separate abstract).ConclusionsOur phase 2, double-blind, randomized controlled trial demonstrated that ATI-450 is safe and well tolerated in an acutely ill patient population. Furthermore, we observe a relative- reduction (incremental to dexamethasone) in IL-6, IL-8, TNFα, and G-CSF in patients treated with ATI-450 over placebo.Table 1:
  • ||||||||||  zunsemetinib (ATI-450) / Aclaris
    Enrollment change, Trial completion date, Trial termination:  Study of ATI-450 in Patients With Cryopyrin-Associated Periodic Syndrome (CAPS) (clinicaltrials.gov) -  Apr 22, 2021   
    P2a,  N=1, Terminated, 
    Whether the better biomechanical properties lead to a reduction in pseudarthrosis must be proven in clinical trials. N=10 --> 1 | Trial completion date: Jun 2021 --> Feb 2021 | Recruiting --> Terminated; Due to patient enrollment challenges stemming from the COVID-19 pandemic, Aclaris has decided to focus its efforts and resources on other immuno-inflammatory diseases.
  • ||||||||||  zunsemetinib (ATI-450) / Aclaris
    Enrollment closed, Enrollment change, Trial primary completion date:  A Trial of Aclaris Therapeutics, Inc. (ATI)-450 in Patients With Moderate-severe Novel Coronavirus Disease 2019 (COVID-19) (clinicaltrials.gov) -  Apr 5, 2021   
    P2,  N=20, Active, not recruiting, 
    N=10 --> 1 | Trial completion date: Jun 2021 --> Feb 2021 | Recruiting --> Terminated; Due to patient enrollment challenges stemming from the COVID-19 pandemic, Aclaris has decided to focus its efforts and resources on other immuno-inflammatory diseases. Recruiting --> Active, not recruiting | N=36 --> 20 | Trial primary completion date: Jul 2021 --> Feb 2021