- |||||||||| P2 data, P3 data, Review, Journal: Clinical trials in systemic lupus erythematosus: the dilemma-Why have phase III trials failed to confirm the promising results of phase II trials? (Pubmed Central) - Oct 7, 2022
Thus, trials with many drugs against different targets, such as CD22, IL-12 and IL-23 or tyrosine kinases, have been carried out in recent years.A frustrating feature of some of the biologic drugs used to treat SLE has been the reporting of successful phase II trials followed by failures of the phase III trials.In this review, we will focus on phase II and III trials carried out with epratuzumab (anti CD22), baricitinib (Janus kinases inhibitor), rigerimod (P140 peptide) and ustekinumab (IL-12 and IL-23 inhibitor) and consider the reasons for their ultimate failure to 'make the grade'. Likewise, we will try to explain the possible reasons that can influence why good results may be obtained in phase II trials and lead to undue optimism.
- |||||||||| Lupuzor (rigerimod) / ImmuPharma, Alora Pharma
Preclinical, Journal: In Vivo Remodeling of Altered Autophagy-Lysosomal Pathway by a Phosphopeptide in Lupus. (Pubmed Central) - Apr 7, 2021
For the first time, it is demonstrated that by occluding the intralysosome uptake of CMA substrates, a therapeutic molecule can attenuate excessive CMA activity in a pathological pro-inflammatory context and protect against hyperinflammation. This recovery effect of P140 on hyperactivated CMA is not only important for lupus therapy but potentially also for treating other (auto)inflammatory diseases, including neurologic and metabolic disorders, where CMA modulation would be highly beneficial.
- |||||||||| Lupuzor (rigerimod) / ImmuPharma, Alora Pharma
[VIRTUAL] CHAPERONE-MEDIATED AUTOPHAGY IN NORMAL AND ACUTE MYELOID LEUKEMIA GRANULOCYTIC DIFFERENTIATION () - May 16, 2020 - Abstract #EHA2020EHA_760;
To reinforce the data, we took advantage of a CMA targeting therapy, currently in clinical trial to treat systemic lupus erythematosus (SLE), P140/Lupuzor®...Conclusion Altogether, we demonstrated that reduction of CMA activity is necessary for efficient granulocytic differentiation of hematopoietic cells. Therefore, CMA activity may impede AML differentiation and thus participate in maintaining an immature AML phenotype.
- |||||||||| Lupuzor (rigerimod) / ImmuPharma
Journal, IO Biomarker: Lupus regulator peptide P140 represses B-cell differentiation by reducing HLA class II molecule overexpression. (Pubmed Central) - Jul 24, 2019
Our findings show that P140 down-regulates HLA class II overexpression in human lupus B cells and that likely via a resulting lack of T cell signaling and activation, it hampers B cells differentiation into autoantibody-secreting plasma cells. This mechanism likely switches off the downstream events leading to pathogenic autoantibodies secretion, thus explaining the highly promising results obtained in P140/Lupuzor-based clinical trials.
- |||||||||| Lupuzor (rigerimod) / ImmuPharma, Alora Pharma
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date: Study of Repeated Administration of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus (clinicaltrials.gov) - Nov 29, 2018
P3, N=62, Active, not recruiting,
Active, not recruiting --> Completed Recruiting --> Active, not recruiting | N=100 --> 62 | Trial completion date: Oct 2018 --> Mar 2019 | Trial primary completion date: Oct 2018 --> Feb 2019
- |||||||||| Lupuzor (rigerimod) / ImmuPharma, Alora Pharma
Trial completion: A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus (clinicaltrials.gov) - Jan 17, 2018
P3, N=200, Completed,
Not yet recruiting --> Recruiting Active, not recruiting --> Completed
- |||||||||| Lupuzor (rigerimod) / ImmuPharma, Alora Pharma
Trial initiation date, Trial primary completion date: A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus (clinicaltrials.gov) - Jan 26, 2017
P3, N=200, Active, not recruiting,
Active, not recruiting --> Completed Initiation date: Dec 2015 --> Mar 2015 | Trial primary completion date: Jun 2017 --> Mar 2018
- |||||||||| Lupuzor (rigerimod) / ImmuPharma, Alora Pharma
Enrollment closed: A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus (clinicaltrials.gov) - Jan 9, 2017
P3, N=200, Active, not recruiting,
Initiation date: Dec 2015 --> Mar 2015 | Trial primary completion date: Jun 2017 --> Mar 2018 Recruiting --> Active, not recruiting
- |||||||||| Lupuzor (rigerimod) / ImmuPharma, Alora Pharma
Enrollment open, Trial initiation date: A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus (clinicaltrials.gov) - Dec 14, 2015
P3, N=200, Recruiting,
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting | Initiation date: Sep 2015 --> Dec 2015
|
