Phase 3 Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Reltecimod as Compared to Placebo in Addition to Standard of Care in Patients With Sepsis-associated Acute Kidney Injury (SA-AKI)

Phase 3 multicenter study to be conducted in up to 90 qualified participating sites globally to assess the efficacy and safety of Reltecimod vs placebo in patients with sepsis-associated Stage 2/3 AKI.

Start Date24 May 2018

Sponsor / Collaborator

Atox Bio Ltd.

NCT02469857 / CompletedPhase 3

Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Study of AB103 as Compared to Placebo in Patients With Necrotizing Soft Tissue Infections. ACCUTE (AB103 Clinical Composite Endpoint Study in Necrotizing Soft Tissue Infections)

The purpose of this study is to determine whether AB103 is safe and effective in the treatment of patients with necrotizing soft tissue infections (NSTI) receiving standard of care therapy.

Start Date01 Dec 2015

Sponsor / Collaborator

Atox Bio Ltd.

[+1]

NCT01417780 / CompletedPhase 2

Evaluation of Safety, Pharmacokinetics and Immunomodulatory Effects of AB103, a CD28 Co-stimulatory Receptor Antagonist, in Patients Diagnosed With Necrotizing Soft Tissue Infections

A study to evaluate the safety and pharmacokinetics profile of different doses of AB103 administered to patients diagnosed with Necrotizing Soft Tissue Infections that are scheduled for an urgent surgical intervention as part of their standard of care.

Start Date01 Dec 2011

Sponsor / Collaborator

Atox Bio Ltd.

100 Clinical Results associated with Reltecimod

100 Translational Medicine associated with Reltecimod

100 Patents (Medical) associated with Reltecimod

Literatures (Medical) associated with Reltecimod

01 Aug 2021·The journal of trauma and acute care surgery

Resolution of organ dysfunction as a predictor of long-term survival in necrotizing soft tissue infections: Analysis of the AB103 Clinical Composite Endpoint Study in Necrotizing Soft Tissue Infections trial and a retrospective claims database-linked chart study

Article

Author: Brakenridge, Scott C. ; Maislin, Greg ; Wilfret, David A. ; Dankner, Wayne M. ; Walker, Valery ; May, Addison K. ; Bulger, Eileen M. ; Andrade, Katherine E.

BACKGROUND:

Necrotizing soft tissue infections (NSTIs) are an acute surgical condition with high morbidity and mortality. Timely identification, resuscitation, and aggressive surgical management have significantly decreased inpatient mortality. However, reduced inpatient mortality has shifted the burden of disease to long-term mortality associated with persistent organ dysfunction.

METHODS:

We performed a combined analysis of NSTI patients from the AB103 Clinical Composite Endpoint Study in Necrotizing Soft Tissue Infections randomized-controlled interventional trial (ATB-202) and comprehensive administrative database (ATB-204) to determine the association of persistent organ dysfunction on inpatient and long-term outcomes. Persistent organ dysfunction was defined as a modified Sequential Organ Failure Assessment (mSOFA) score of 2 or greater at Day 14 (D14) after NSTI diagnosis, and resolution of organ dysfunction defined as mSOFA score of 1 or less.

RESULTS:

The analysis included 506 hospitalized NSTI patients requiring surgical debridement, including 247 from ATB-202, and 259 from ATB-204. In both study cohorts, age and comorbidity burden were higher in the D14 mSOFA ≥2 group. Patients with D14 mSOFA score of 1 or less had significantly lower 90-day mortality than those with mSOFA score of 2 or higher in both ATB-202 (2.4% vs. 21.5%; p < 0.001) and ATB-204 (6% vs. 16%: p = 0.008) studies. In addition, in an adjusted covariate analysis of the combined study data sets D14 mSOFA score of 1 or lesss was an independent predictor of lower 90-day mortality (odds ratio, 0.26; 95% confidence interval, 0.13–0.53; p = 0.001). In both studies, D14 mSOFA score of 1 or less was associated with more favorable discharge status and decreased resource utilization.

CONCLUSION:

For patients with NSTI undergoing surgical management, persistent organ dysfunction at 14 days, strongly predicts higher resource utilization, poor discharge disposition, and higher long-term mortality. Promoting the resolution of acute organ dysfunction after NSTI should be considered as a target for investigational therapies to improve long-term outcomes after NSTI.

LEVEL OF EVIDENCE:

Prognostic/epidemiology study, level III

01 Sep 2020·Annals of surgeryQ1 · MEDICINE

Commentary on “Results of a Multicenter, Phase 3 Randomized Controlled Trial of Reltecimod”

Q1 · MEDICINE

Article

Author: Nathens, Avery B

01 Sep 2020·Annals of surgeryQ1 · MEDICINE

A Novel Immune Modulator for Patients With Necrotizing Soft Tissue Infections (NSTI)

Q1 · MEDICINE

Article

Author: Green, John M ; Henry, Sharon ; Toschlog, Eric ; Evans, David C ; Dankner, Wayne M ; May, Addison K ; Fagenholz, Peter ; Sperry, Jason L ; Wilfret, David ; Bulger, Eileen M ; Bernard, Andrew C ; Robinson, Bryce R H ; Maislin, Greg ; Martin, Niels D

Background and Objective::

Reltecimod, a CD 28 T-lymphocyte receptor mimetic, inhibits T-cell stimulation by an array of bacterial pathogens. A previous phase 2 trial demonstrated improved resolution of organ dysfunction after NSTI. We hypothesized that early administration of reltecimod would improve outcome in severe NSTI.

Methods::

Randomized, double-blind, placebo-controlled trial of single dose reltecimod (0.5 mg/kg) administered within 6 hours of NSTI diagnosis at 65 of 93 study sites. Inclusion: surgical confirmation of NSTI and organ dysfunction [modified Sequential Organ Failure Assessment Score (mSOFA) score ≥3]. Primary analysis was modified Intent-to-Treat (mITT), responder analysis using a previously validated composite endpoint, necrotizing infection clinical composite endpoint, defined as: alive at day 28, ≤3 debridements, no amputation beyond first operation, and day 14 mSOFA ≤1 with ≥3 point reduction (organ dysfunction resolution). A prespecified, per protocol (PP) analysis excluded 17 patients with major protocol violations before unblinding.

Results::

Two hundred ninety patients were enrolled, mITT (Reltecimod 142, Placebo 148): mean age 55 ± 15 years, 60% male, 42.4% diabetic, 28.6% perineal infection, screening mSOFA mean 5.5 ± 2.4. Twenty-eight-day mortality was 15% in both groups. mITT necrotizing infection clinical composite endpoint success was 48.6% reltecimod versus 39.9% placebo, P = 0.135 and PP was 54.3% reltecimod versus 40.3% placebo, P = 0.021. Resolution of organ dysfunction was 65.1% reltecimod versus 52.6% placebo, P = 0.041, mITT and 70.9% versus 53.4%, P = 0.005, PP.

Conclusion::

Early administration of reltecimod in severe NSTI resulted in a significant improvement in the primary composite endpoint in the PP population but not in the mITT population. Reltecimod was associated with improved resolution of organ dysfunction and hospital discharge status.

News (Medical) associated with Reltecimod

24 May 2021

·www.globenewswire.com

Acute Bacterial Skin and Skin Structure Infections Pipeline Featuring Plethora of Emerging Drugs, Key Companies

Los Angeles, USA, May 24, 2021 (GLOBE NEWSWIRE) -- Acute Bacterial Skin and Skin Structure Infections Pipeline Featuring Plethora of Emerging Drugs, Key Companies Ceftobiprole Medocaril under Phase III trials is expected to turn out to be the most effective treatment of Acute Bacterial Skin and Skin Structure Infections. DelveInsight’s ‘Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Pipeline Insights’ report offers a detailed picture of the ABSSSI emerging therapies expected to enter the Acute Bacterial Skin and Skin Structure Infections market along with detailed coverage of the pipeline therapies under development in pre-clinical as well as clinical stages of development, partnerships taking place in the domain, recent happenings in space and growth prospects across the Diabetes domain. Some of the key highlights of the ABSSSI Pipeline report: Request for Sample to know more about the therapies that are set to grab maximum patient pool @ ABSSSI Emerging Therapies and Forecast Acute Bacterial Skin and Skin Structure Infection is a bacterial infection of the skin and associated tissues. The FDA defines skin and skin structure infections as an acute bacterial skin and skin structure infection or ABSSSI if the infection is accompanied by redness, edema, and/or induration of a minimum surface area of 75 cm2, accompanied by lymph node enlargement or systemic symptoms such as fever ≥38°C (100.4°F). Some of the most common bacterial pathogens that cause Acute Bacterial Skin and Skin Structure Infections are Streptococcus pyogenes and Staphylococcus aureus, including methicillin-resistant S.aureus. Less common causes include other Streptococcus species, Enterococcus faecalis, or Gram Negative bacteria. The severity of Acute Bacterial Skin and Skin Structure Infections has led to an increasing emphasis on the identification of novel strategies to treat this disease. For more information on emerging drugs, visit Acute Bacterial Skin and Skin Structure Infections Pipeline Analysis ABSSSI Pipeline Drugs Request for Sample to know more @ Acute Bacterial Skin and Skin Structure Infections Pipeline Analysis, Key Companies and Futuristic Trends Acute Bacterial Skin and Skin Structure Infections Drugs and Therapeutic Assessment The ABSSSI Pipeline report presents comprehensive insights into active ABSSSI pipeline assets segmented by Stage, ABSSSI Product Type, Route of Administration, Molecule Type, Target, and Indications of various drugs. By Product Type By Stage By Molecule Type By Route of Administration By Mechanism of Action By Targets By Stage and Route of AdministrationBy Stage and Product Type Reach out for Rich and Deep Market Assessment and Consulting Solutions Scope of the Report Coverage: GlobalKey Players: Basilea Pharmaceutica, TenNor Therapeutics, Innovation Pharmaceuticals, Debiopharm Group, MicuRx Pharmaceuticals, Taxis Pharmaceuticals, Botanix pharmaceuticals, Motif Bio, KBP Biosciences, Atox Bio and others. Key ABSSSI Pipeline Therapies: Ceftobiprole medocaril, TNP-2092, Brilacidin, Afabicin, Contezolid acefosamil, TXA709, Cannabidiol, KBP-7072, Nemonoxacin, AB-103 and others. Reach out @ Acute Bacterial Skin and Skin Structure Infections Pipeline: Novel therapies and emerging technologies Table of Contents Visit to know more of what’s covered @ ABSSSI Emerging Therapies Related ReportsAcute Bacterial Skin And Skin Structure Infections MarketDelveInsight's "Acute Bacterial Skin and Skin Structure Infections - Market Insights, Epidemiology, and Market Forecast-2030" report. Acne Vulgaris MarketDelveInsight's "Acne Vulgaris Market Insights, Epidemiology, and Market Forecast-2030" report. Moderate To Severe Atopic Dermatitis MarketDelveInsight's "Moderate to Severe Atopic Dermatitis (AD) - Market Insights, Epidemiology, and Market Forecast-2030" report. Acral Lentiginous Melanoma MarketDelveInsight's "Acral lentiginous melanoma - Market Insights, Epidemiology, and Market Forecast-2030" report. Androgenetic Alopecia MarketDelveInsight's "Androgenetic Alopecia Market Insights, Epidemiology, and Market Forecast-2030" report. Related Posts ABSSSI Market and Key Treatments Atopic Dermatitis MarketRosacea Pipeline and Therapies Marijuana Clinical TrialsOpiate Withdrawal Cocktail About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing end-to-end comprehensive solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. For more insights, visit Pharma, Healthcare, and Biotech News

100 Deals associated with Reltecimod

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute kidney injury due to sepsis	Phase 3	US	Atox Bio Ltd.	24 May 2018
Acute kidney injury due to sepsis	Phase 3	FR	Atox Bio Ltd.	24 May 2018
Peritonitis	Phase 3	US	Atox Bio Ltd.	24 May 2018
Peritonitis	Phase 3	FR	Atox Bio Ltd.	24 May 2018
Fasciitis, Necrotizing	Phase 3	US	Atox Bio Ltd.	01 Dec 2015
Fasciitis, Necrotizing	Phase 3	FR	Atox Bio Ltd.	01 Dec 2015
Fournier Gangrene	Phase 3	US	Atox Bio Ltd.	01 Dec 2015
Fournier Gangrene	Phase 3	FR	Atox Bio Ltd.	01 Dec 2015
Soft Tissue Infections	Phase 3	US	Atox Bio Ltd.	01 Dec 2015
Soft Tissue Infections	Phase 3	FR	Atox Bio Ltd.	01 Dec 2015

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01417780 (CTgov)	Phase 2	Soft Tissue Infections	43	AB103 (AB103 0.25 mg/kg)	joporjxjrn(dftnirnnua) = famqbwbwmk nzdjsifdcb (emxqdwlulg, wcmvgtujlv - fgpitloiuy) View more	-	18 Aug 2021
				AB103 (AB103 0.5 mg/kg)	joporjxjrn(dftnirnnua) = qwktezpeki nzdjsifdcb (emxqdwlulg, gvsnctfkwh - peewibqbzh) View more
NCT01166984 (CTgov)	Phase 1	-	25	AB103 (AB103 7.5 µg/kg)	uzjddrtcva(yokkfswvmz) = ltbynfvvgn ahiegyxkna (hwsaccttzf, jvlksnwglc - hbywrdwwdu) View more	-	27 Apr 2021
				AB103 (AB103 37.5 µg/kg)	uzjddrtcva(yokkfswvmz) = nxwhhdmkzm ahiegyxkna (hwsaccttzf, sksqmovszl - qtjvqwbmci) View more
NCT02469857 (Pubmed \| Ann Surg)	Phase 3	Soft Tissue Infections	290	Reltecimod	smltculfdl(zmkwxqibhp) = dxfckppthc uopcbzfrus (iuoqnxonyu )	Positive	08 Jul 2020
				Placebo	smltculfdl(zmkwxqibhp) = pggazzuieu uopcbzfrus (iuoqnxonyu )

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