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- pegtarazimod (RLS-0071) / ReAlta
RLS-0071 Independently Inhibits Neutrophil Migration and Myeloperoxidase Activity and NETosis in Humans Challenged With LPS by Inhalation (San Diego Convention Center, Room 25A-C (Upper Level)) - Feb 20, 2024 - Abstract #ATS2024ATS_7213;
P1b
Overall, these results suggest that RLS-0071 can inhibit key drivers of neutrophil-mediated lung damage, MPO level or activity, and NETosis, independent of sputum neutrophil counts. These encouraging results support the further development of RLS-0071 for neutrophil-mediated lung diseases like acute exacerbations of COPD.
- || RLS-0071 / ReAlta
Enrollment open: Safety, PK and PD Relationships of RLS-0071 in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease (clinicaltrials.gov) - Jan 11, 2024
P2, N=24, Recruiting, Sponsor: ReAlta Life Sciences, Inc.
These encouraging results support the further development of RLS-0071 for neutrophil-mediated lung diseases like acute exacerbations of COPD. Not yet recruiting --> Recruiting
- || RLS-0071 / ReAlta
New P2 trial: Safety, PK and PD Relationships of RLS-0071 in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease (clinicaltrials.gov) - Dec 17, 2023
P2, N=24, Not yet recruiting, Sponsor: ReAlta Life Sciences, Inc.
- || pegtarazimod (RLS-0071) / ReAlta
Enrollment open, Trial initiation date: STAR: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of RLS-0071 in Newborns With Moderate or Severe Hypoxic-Ischemic Encephalopathy Undergoing Therapeutic Hypothermia (clinicaltrials.gov) - Aug 8, 2023
P2, N=42, Recruiting, Sponsor: ReAlta Life Sciences, Inc.
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting | Initiation date: Apr 2023 --> Jul 2023
- RLS-0071 / ReAlta
Late Breaking Abstract - Safety and Efficacy of RLS-0071 on Neutrophils and Inflammatory Mediators in a Phase (PS-6 in poster area) - Jul 4, 2023 - Abstract #ERS2023ERS_5527;
Not yet recruiting --> Recruiting | Initiation date: Apr 2023 --> Jul 2023 Cell and molecular biology; Physiology; Public health; General respiratory patient care; Pulmonary rehabilitation; Imaging
- | RLS-0071 / ReAlta
Journal: RLS-0071 Moderated Elevated Myeloperoxidase Level and Activity in an Asymptomatic Subject in Clinical Trial RLS-0071-101. (Pubmed Central) - May 30, 2023
There were no other clinically meaningful safety observations for this subject. CONCLUSIONS This observation suggests RLS-0071 has the therapeutic potential to moderate plasma myeloperoxidase levels and activity and modulate diseases in which myeloperoxidase contributes to pathogenesis.
- || pegtarazimod (RLS-0071) / ReAlta
Trial completion, Enrollment change: A Clinical Study to Determine the Safety, Tolerability and Effect of RLS-0071 Doses When Given to Healthy Adults After Inhaling LPS (clinicaltrials.gov) - Mar 31, 2023
P1b, N=30, Completed, Sponsor: ReAlta Life Sciences, Inc.
CONCLUSIONS This observation suggests RLS-0071 has the therapeutic potential to moderate plasma myeloperoxidase levels and activity and modulate diseases in which myeloperoxidase contributes to pathogenesis. Recruiting --> Completed | N=48 --> 30
- RLS-0071 / ReAlta
RLS-0071, A Novel Dual-targeting Anti-inflammatory Agent, Demonstrates Proof of Mechanism in a Phase 1b Inhaled LPS Study Significantly Reducing Lung Neutrophils (Walter E. Washington Convention Center, Area D, Hall C (Lower Level)) - Mar 25, 2023 - Abstract #ATS2023ATS_8506;
P1b
Overall, these results demonstrate that RLS-0071 met proof of mechanism in humans and can decrease neutrophil-mediated inflammation in the lungs by greater than 40% with a responder rate of 80% for a 10 mg/kg/dose regimen. These findings warrant further efficacy evaluation of RLS-0071 for the treatment of neutrophil-dominated lung diseases.
- || pegtarazimod (RLS-0071) / ReAlta
New P2 trial: STAR: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of RLS-0071 in Newborns With Moderate or Severe Hypoxic-Ischemic Encephalopathy Undergoing Therapeutic Hypothermia (clinicaltrials.gov) - Mar 21, 2023
P2, N=42, Not yet recruiting, Sponsor: ReAlta Life Sciences, Inc.
- || pegtarazimod (RLS-0071) / ReAlta
Enrollment open: A Clinical Study to Determine the Safety, Tolerability and Effect of RLS-0071 Doses When Given to Healthy Adults After Inhaling LPS (clinicaltrials.gov) - May 30, 2022
P1b, N=48, Recruiting, Sponsor: ReAlta Life Sciences, Inc.
These findings warrant further efficacy evaluation of RLS-0071 for the treatment of neutrophil-dominated lung diseases. Not yet recruiting --> Recruiting
- RLS-0071 / ReAlta
DUAL TARGETING PEPTIDE RLS-0071 REDUCES AND INHIBITS MYELOPEROXIDASE (MPO) IN HEALTHY HUMAN VOLUNTEER () - May 24, 2022 - Abstract #EULAR2022EULAR_3050;
Not yet recruiting --> Recruiting These results suggest promise for RLS-0071 to reversibly moderate plasma MPO activity and potentially affect MPO-mediated diseases including acute coronary syndrome (ACS), atheromatous plaque vulnerability and auto immune conditions.4,5,6,7.
- || pegtarazimod (RLS-0071) / ReAlta
New P1 trial: A Clinical Study to Determine the Safety, Tolerability and Effect of RLS-0071 Doses When Given to Healthy Adults After Inhaling LPS (clinicaltrials.gov) - Apr 28, 2022
P1b, N=48, Not yet recruiting, Sponsor: ReAlta Life Sciences, Inc.
- || RLS-0071 / ReAlta
Preclinical, Review, Journal: The EPICC Family of Anti-Inflammatory Peptides: Next Generation Peptides, Additional Mechanisms of Action, and In Vivo and Ex Vivo Efficacy. (Pubmed Central) - Apr 9, 2022
Next generation EPICC peptides containing a sarcosine residue substitution in various positions within the peptide sequence possess aqueous solubility in the absence of PEGylation and demonstrate enhanced complement and neutrophil inhibitory activity compared to RLS-0071. This review details the development of the EPICC peptides, elucidation of their dual-acting complement and neutrophil inhibitory activities and efficacy in ex vivo systems using human clinical specimens and in vivo efficacy in animal disease models.
- ||| RLS-0071 / ReAlta
New P1 trial: A Phase 1 SAD/MAD Study of RLS-0071 in Healthy Volunteers in Support of a COVID-19 Development Program (clinicaltrials.gov) - Mar 27, 2022
P1, N=56, Completed, Sponsor: ReAlta Life Sciences, Inc.
- RLS-0071 / ReAlta
RLS-0071-101 a study in healthy human volunteers demonstrates safety, complement and inflammatory effector target engagement activity of this novel peptide (Poster Hall) - Mar 6, 2022 - Abstract #AAN2022AAN_2714;
Pharmacodynamic testing confirmed target engagement and biomarker changes consistent with known mechanisms of action for this dual-targeting anti-inflammatory peptide. In light of confirmed RLS-0071 based neuroprotection in animal models of HIE and its now confirmed excellent safety profile in healthy human volunteers, this peptide appears safe and should be considered for human studies as an intervention to decrease neurological injury from HIE.
- RLS-0071 / ReAlta
RLS-0071 Reduces Inflammatory Biomarkers in T2 Low (neutrophilic) Asthma Animal Model (Room 303-304 (South Building, Level 3), Moscone Center) - Feb 19, 2022 - Abstract #ATS2022ATS_3992;
Compared to animals not receiving RLS-0071, BALF of animals treated with RLS-0071 showed a reduction in neutrophil count, MPO and free DNA demonstrating that RLS-0071 can reduce neutrophil sequestration and activation in the lung modulating neutrophil-mediated asthma in this rat model. The ability of RLS-0071 to mitigate neutrophilic asthma in this rodent model has potential for utility as a therapeutic in acute neutrophil-mediated pulmonary exacerbations including steroid refractory, T2 low asthma.
- | RLS-0071 / ReAlta
Preclinical, Journal: Peptide Inhibitor of Complement C1, RLS-0071, Reduces Zosteriform Spread of Herpes Simplex Virus Type 1 Skin Infection and Promotes Survival in Infected Mice. (Pubmed Central) - Feb 4, 2022
Here, we report that treatment of cutaneous infections of HSV-1 and ACV-HSV-1 in BALB/cJ mice with RLS-0071 significantly reduced the rate of mortality, decreased zosteriform spread, and enhanced the healing of the infection-associated lesions compared to control-treated animals. Therefore, RLS-0071 may work synergistically with other antiviral drugs to aid in wound healing of HSV-1 cutaneous infection and may potentially aid in rapid wound healing of other pathology not limited to HSV-1.
- | RLS-0071 / ReAlta
Enrollment change, Trial completion date, Trial withdrawal, Trial primary completion date: A Study of RLS-0071 in Patients With Acute Lung Injury Due to COVID-19 Pneumonia in Early Respiratory Failure (clinicaltrials.gov) - Feb 4, 2022
P1, N=0, Withdrawn, Sponsor: ReAlta Life Sciences, Inc.
Therefore, RLS-0071 may work synergistically with other antiviral drugs to aid in wound healing of HSV-1 cutaneous infection and may potentially aid in rapid wound healing of other pathology not limited to HSV-1. N=42 --> 0 | Trial completion date: Jul 2021 --> Dec 2022 | Not yet recruiting --> Withdrawn | Trial primary completion date: Mar 2021 --> Sep 2022
- | RLS-0071 / ReAlta
Preclinical, Journal: Peptide inhibition of acute lung injury in a novel two-hit rat model. (Pubmed Central) - Dec 1, 2021
Compared to animals not receiving RLS-0071, lungs of animals treated with a single dose of RLS-0071 showed significant reduction in ALI as well as reduced levels of C5a, free DNA and inflammatory cytokines in the blood. These results demonstrate that RLS-0071 can modulate neutrophil-mediated ALI in this novel rat model.
- | RLS-0071 / ReAlta
Preclinical, Journal: Classical complement pathway inhibition reduces brain damage in a hypoxic ischemic encephalopathy animal model. (Pubmed Central) - Nov 24, 2021
RLS-0071 alone or in combination with hypothermia improved both short-term and long-term memory. These findings suggest that modulation by RLS-0071 can potentially decrease brain damage resulting from HIE.
- | RLS-0071 / ReAlta
Preclinical, Journal: Peptide inhibition of neutrophil-mediated injury after in vivo challenge with supernatant of Pseudomonas aeruginosa and immune-complexes. (Pubmed Central) - Nov 21, 2021
RLS-0071 injection decreased myeloperoxidase activity and NETs in the peritoneal fluid generally to baseline levels in the presence of P. aeruginosa supernatant or immune-complexes. Taken together, RLS-0071 demonstrated the ability to inhibit myeloperoxidase activity and NET formation in vivo when initiated by different inflammatory stimuli including shed or secreted bacterial constituents as well as immune-complexes.
- RLS-0071 / ReAlta
[VIRTUAL] RLS-0071 improves survival in a rat model of intestinal necrosis () - Oct 6, 2021 - Abstract #IDWeek2021IDWeek_1894;
Taken together, RLS-0071 demonstrated the ability to inhibit myeloperoxidase activity and NET formation in vivo when initiated by different inflammatory stimuli including shed or secreted bacterial constituents as well as immune-complexes. The results of these experiments demonstrate that RLS-0071 can increase survival after intestinal perforation by multi-pronged modulation of complement activation, neutrophil immune mechanisms and cytokine mediated inflammatory responses.
- RLS-0071 / ReAlta
[VIRTUAL] Myeloperoxidase Activity in Individuals with Antineutrophil Cytoplasmic Antibodies (ANCA) Can Be Inhibited by RLS-0071 () - Sep 21, 2021 - Abstract #ACRCONVERGENCE2021ACR_CONVERGENCE_790;
Additionally, RLS-0071 inhibited MPO activity in plasma acquired from individuals with ANCA associated pathophysiology. Future studies will focus on elucidating relationships between MPO activity, MPO quantity, free plasma DNA as a surrogate measurement of NETs and anti-MPO titers.
- RLS-0071 / ReAlta
[VIRTUAL] Classical Complement Pathway Inhibitor, RLS-0071 Does Not Impede Platelet Function () - Aug 16, 2021 - Abstract #AABB2021AABB_351;
These data suggest that RLS-0071 does not impede platelet aggregation at concentrations up to 2mg/ml. This study performed in addition to pre-clinical studies support clinical development plans for use in individuals with alloimmune platelet refractoriness.
- RLS-0071 / ReAlta
[VIRTUAL] RLS-0071 Inhibits Acute Lung Injury in a Novel 2-Hit Model () - Mar 14, 2021 - Abstract #ATS2021ATS_1053;
RLS-0071 demonstrated the ability to prevent downstream C5a proinflammatory signaling via complement modulation consistent with the observed reduction of pro-inflammatory cytokines production such as IL-1, IL-6, and TNFα. RLS-0071 further modulates the innate inflammatory response by inhibiting NETosis displaying synergistic mechanism of actions in this rat model of ALI.
- | RLS-0071 / ReAlta
New P1 trial: A Study of RLS-0071 in Patients With Acute Lung Injury Due to COVID-19 Pneumonia in Early Respiratory Failure (clinicaltrials.gov) - Oct 4, 2020
P1, N=42, Not yet recruiting, Sponsor: ReAlta Life Sciences, Inc.
- | RLS-0071 / ReAlta
Preclinical, Journal: A complement-mediated rat xenotransfusion model of platelet refractoriness. (Pubmed Central) - Sep 5, 2020
Complement activation initiated by anti-platelet antibodies leads to complement opsonization and decreased platelet viability. A new rat model of platelet refractoriness was developed that adds a new tool for elucidating the mechanisms of platelet refractoriness.