A Randomised, Double-blind, Double-dummy, Placebo-controlled, Parallel-group Multi-centre Clinical Proof-of-principle Trial in Adult Subjects With Newly Diagnosed Type 1 Diabetes Mellitus Investigating the Effect of NNC0114-0006 and Liraglutide on Preservation of Beta-cell Function

This trial is conducted globally. The aim of this trial is to assess the clinical proof-of-principle of NNC0114-0006 and liraglutide on preservation of beta-cell function in adult subjects with newly diagnosed type 1 diabetes mellitus.

Start Date10 Nov 2015

Sponsor / Collaborator

Novo Nordisk A/S

NCT01751152 / CompletedPhase 2

A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Assess Clinical Efficacy and Safety of NNC0114-0006 in Subjects With Active Crohn's Disease

This trial is conducted in Europe and the United States of America (USA). The aim of the trial is to assess clinical efficacy and safety of NNC0114-0006 in subjects with active Crohn's disease.

Start Date01 Feb 2013

Sponsor / Collaborator

Novo Nordisk A/S

EUCTR2012-002432-93-CZ / Not yet recruitingNot Applicable

A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy and safety of NNC0114-0006 in subjects with active Crohn’s disease

Start Date18 Jan 2013

Sponsor / Collaborator

Novo Nordisk A/S

100 Clinical Results associated with NN-8828

100 Translational Medicine associated with NN-8828

100 Patents (Medical) associated with NN-8828

Literatures (Medical) associated with NN-8828

01 May 2021·RMD OpenQ2 · MEDICINE

Long-term safety and effectiveness of canakinumab therapy in patients with cryopyrin-associated periodic syndrome: results from the β-Confident Registry

Q2 · MEDICINE

ArticleOA

Author: Walker, Ulrich A ; Vritzali, Eleni ; Noviello, Stephanie ; Hawkins, Philip N ; Kuemmerle-Deschner, Jasmin B ; Poll, Tom van der ; Tilson, Hugh H ; Hoffman, Hal M ; Levy, Jeremy

ObjectiveTo report the long-term safety and effectiveness of canakinumab, a fully human anti-interleukin 1β monoclonal antibody, in patients with cryopyrin-associated periodic syndromes (CAPS), including familial cold autoinflammatory syndrome (FCAS), Muckle-Wells syndrome (MWS) and neonatal-onset multisystem inflammatory disease (NOMID), in a real-world setting.MethodsFrom December 2009 to December 2015, the β-Confident Registry prospectively enrolled patients with CAPS and non-CAPS conditions who received canakinumab per routine care and were prospectively followed for up to 6 years. The registry protocol did not mandate specific visits or procedures; however, all observed adverse events (AEs) and serious adverse events (SAEs) had to be recorded. Canakinumab effectiveness was evaluated by Physician’s Global Assessment (PGA).ResultsOf 288 patients enrolled, 3 were excluded due to missing informed consent. Among the remaining 285 patients, 243 (85.3%) were patients with CAPS and 42 (14.7%) had atypical CAPS (6.3%) or other conditions (8.4%). The median age was 26.6 years. Based on PGA, 58 of 123 (47.2%) patients with CAPS had no disease activity at 48 months, and 65 of 123 (52.8%) experienced mild/moderate disease activity at 48 months. Among CAPS phenotypes, AE incidence rates per 100 patient-years were lowest for FCAS (73.1; 95% CI 60.3 to 87.8) compared with those with MWS (105.0; 95% CI 97.2 to 113.2) or NOMID (104.6; 95% CI 86.6 to 125.2). One hundred twenty-eight SAEs were reported in 68 patients with CAPS (incidence rate/100 patient-years, 14.0; 95% CI 11.6 to 16.6). One death (metastatic rectal adenocarcinoma in a patient with MWS) was reported.ConclusionsThe response to canakinumab was sustained for up to 6 years. Canakinumab demonstrated a favourable safety profile over long-term treatment in patients with CAPS.Trial registration numberNCT01213641.

07 Nov 2020·European Heart JournalQ1 · MEDICINE

New challenges in the management of acute coronary syndromes: residual risk and sex-related inequalities

Q1 · MEDICINE

Article

Author: Crea, Filippo

Although optimal control of cardiovascular risk factors is fundamental for reducing cardiovascular risk, abating the residual risk is emerging as a key target.In the past 30 years, a remarkable series of exptl. and clin. studies have shown that inflammation plays an important role in all phases of atherosclerotic plaque progression including plaque disruption leading to acute coronary syndromes (ACS).The Cantos study was the first trial to prove that the 'inflammatory hypothesis' is correct as canakinumab, an anti interleukin-1b monoclonal antibody, improved the outcome of patients who had experienced recent myocardial infarction (MI).However, the clin. benefit was modest, the side effects problematic, and the treatment cost high and nevertheless, this study opened the way to new forms of treatment with anti-inflammatory drugs.In a clin. research manuscript entitled Complete revascularization reduces cardiovascular death in patients with ST segment elevation myocardial infarction and multivessel disease.

01 Apr 2016·Int. Journal of Clinical Pharmacology and TherapeuticsQ4 · MEDICINE

Safety, PK, and PD of recombinant anti-interleukin-21 monoclonal antibody in a first-in-human trial

Q4 · MEDICINE

Article

Author: Ignatenko, Stanislav ; Skrumsager, Birte K. ; Mouritzen, Ulrik

OBJECTIVEThis first-in-human, randomized, double-blind, placebo-controlled trial assessed the safety of NNC0114-0005, a human recombinant anti interleukin (IL)-21 monoclonal antibody, for the treatment of rheumatoid arthritis (RA).METHODS AND MATERIALSHealthy male subjects (HS (n = 44)) and patients with active RA treated with methotrexate (n = 20) were randomized 3 : 1 to single IV or SC doses of NNC0114-0005 (0.0025 - 25 mg/kg) or placebo. Safety endpoints, pharmacokinetics, and pharmacodynamics were assessed over 12 weeks.RESULTSAll study participants were analyzed. 37 AEs were reported in 21 NNC0114-0005-treated participants (44%) and 18 AEs in 10 placebo-treated participants (63%), with no dose-dependency. The most common AEs were headache and nasopharyngitis; there were no injection-site reactions Linear pharmacokinetics of NNC0114-0005 were indicated (mean terminal half-life, 2 - 3 weeks). Dose-dependent total IL-21 (free IL-21 and IL-21‒NNC0114-0005 complexes) accumulation was observed. Preliminary signs of reduced RA activity were observed with 25 mg/kg NNC0114-0005.CONCLUSIONSSingle doses of NNC0114-0005 (≤ 25 mg/kg IV; ≤ 4 mg/kg SC) were well tolerated in HS and patients with RA. Accumulation of IL-21-containing complexes suggests neutralization of the target cytokine. Based< on this trial, further trials to explore the efficacy of anti-IL-21 were initiated.

News (Medical) associated with NN-8828

22 Feb 2024

·www.pharmaceutical-technology.com

Immune-Onc’s antibody therapy collects second FDA orphan designation

IO-202 is a monoclonal antibody that targets leukocyte immunoglobulin-like receptor subfamily B member 4 (LILRB4), which can suppress immunity in solid tumours. Image Credit: crystal light / Shutterstock. The US Food and Drug Administration (FDA) has granted an orphan drug designation to Immune-Onc Therapeutics’ IO-202 for the treatment of a rare blood cancer – chronic myelomonocytic leukaemia (CMML). IO-202 had previously received a fast track designation from the US FDA as a treatment of relapsed or refractory (r/r) CMML in 2023. The therapy was also granted both orphan drug and fast track designations as a treatment for acute myeloid leukaemia (AML) by the FDA in 2020 and 2022, respectively. The orphan drug designations allow for an extended market exclusivity of seven years in the US and developmental incentives such as an exemption of FDA application fees and tax credits for qualified clinical testing. The fast track designations enable earlier interactions with the FDA for the pursuit of accelerated approval. The status also opens chances of rolling reviews. IO-202 is a monoclonal antibody that targets leukocyte immunoglobulin-like receptor subfamily B member 4 (LILRB4), which can suppress immunity in solid tumours. It also mediates the T-cell suppression and infiltration of AML cells. It is being investigated as a monotherapy and in combination with chemotherapy, azacytidine, along with targeted therapy AbbVie /Genentech’s Venclexta (venetoclax), in a Phase I trial (NCT04372433). The study is expected to enrol approximately 106 patients with either r/r AML or r/r CMML. It is expected to conclude in 2026, as per ClinicalTrial.gov. See Also: Harmony wins orphan drug tag for pitolisant to treat Prader-Willi syndrome United Therapeutics sues FDA over handling of Liquidia’s NDA A second Phase I trial (NCT05309187) investigating IO-202 in combination with a PD-1 immune checkpoint inhibitor, MSD’s Keytruda (pembrolizumab) is also currently underway. The study enrolled approximately 200 patients with advanced solid tumours and is expected to be completed in April. Monoclonal antibodies have been identified as a key innovation area for cancer therapy by GlobalData, with multiple companies investing to develop antibody therapies for various indications. In December 2023, AbbVie partnered with BigHat Biosciences to identify and develop antibody therapies in oncology and neuroscience indications. GlobalData is the parent company of Pharmaceutical Technology . Almirall is developing an interleukin-21 (IL-21)-hindering monoclonal antibody, NN-8828, for the treatment of immune-inflammatory dermatological ailments. The company acquired the therapy from Novo Nordisk last week for an undisclosed upfront payment and will be entitled to developmental and commercial milestones, as well as tiered royalties on future global sales.

ImmunotherapyOrphan DrugPhase 1Fast TrackAcquisition

19 Feb 2024

·www.biospace.com

Novo Licenses to Almirall Potential First-in-Class Antibody Candidate

Pictured: Novo Nordisk's corporate headquarters in Denmark/iStock, Ole Schwander Spanish pharma Almirall announced Monday that it has licensed Novo Nordisk’s anti-IL-21 monoclonal antibody NN-8828, which it plans to develop as a treatment for immune inflammatory dermatological diseases and has first-in-class potential. Almirall is looking to “accelerate the development” of NN-8828 with an eye towards eventually debuting the candidate on the global market for “key dermatological diseases,” according to Monday’s announcement. Under the licensing agreement, Novo will receive an undisclosed upfront payment and will be entitled to developmental and commercial milestones, as well as tiered royalties on future global sales. The licensing agreement will allow Almirall to “explore the innovative approach of IL-21 blockage as a possible new pathway to effectively treat a range of dermatological diseases,” CSO Karl Ziegelbauer said in a statement. The pharma, headquartered in Barcelona, Spain, is focused on medical dermatology. NN-8828 is a monoclonal antibody that targets and binds the IL-21 cytokine with high affinity. IL-21 is a key player in the inflammatory cascade and has been implicated in various immune-based skin diseases, including atopic dermatitis, psoriasis, pemphigus and Sjögren's syndrome. By blocking IL-21 signaling, NN-8828 can potentially inhibit the underlying mechanisms of these diseases providing “a promising option for the treatment of inflammatory and autoimmune skin disorders,” according to Almirall. Before punting the candidate over to Almirall, Novo had trialed NN-8828 up to Phase II in non-dermatological conditions. In January 2013, the Danish pharma announced that it was discontinuing the development of NN-8828 in rheumatoid arthritis after the candidate delivered a middling performance in a Phase IIa study. NN-8828 met its primary endpoint of significantly lowering disease activity versus placebo but “the magnitude of the treatment effect did not warrant further development,” according to Novo. The Danish drugmaker continued assessing NN-8828 in other inflammatory diseases, such as Crohn’s disease and systemic lupus erythematosus, but ultimately exited the inflammation space entirely in September 2014. Now part of Almirall’s holdings, NN-8828 joins a pipeline of promising dermatology therapies anchored by lebrikizumab, which is currently undergoing regulatory review in the European Union for the treatment of atopic dermatitis. Almirall licensed the European rights for lebrikizumab from Dermira in June 2019. Eli Lilly acquired Dermira in January 2020. Also under review in the EU is Almirall’s efinaconazole, an investigational treatment for the fungal infection onychomycosis and sarecycline, meant to treat acne. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

License out/inPhase 2AcquisitionPhase 1Clinical Result

100 Deals associated with NN-8828

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Inflammation	Phase 2	RS	Novo Nordisk A/S	01 Sep 2012
Inflammation	Phase 2	ES	Novo Nordisk A/S	01 Sep 2012
Inflammation	Phase 2	BG	Novo Nordisk A/S	01 Sep 2012
Inflammation	Phase 2	LV	Novo Nordisk A/S	01 Sep 2012
Inflammation	Phase 2	HU	Novo Nordisk A/S	01 Sep 2012
Inflammation	Phase 2	PL	Novo Nordisk A/S	01 Sep 2012
Inflammation	Phase 2	RU	Novo Nordisk A/S	01 Sep 2012
Rheumatoid Arthritis	Phase 2	HU	Novo Nordisk A/S	01 Sep 2012
Rheumatoid Arthritis	Phase 2	LV	Novo Nordisk A/S	01 Sep 2012
Rheumatoid Arthritis	Phase 2	ES	Novo Nordisk A/S	01 Sep 2012

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02443155 (CTgov)	Phase 2	Diabetes Mellitus, Type 1	308	liraglutide+NNC0114-0006 (NNC0114-0006 + Liraglutide)	sbhscivaiz(cqhizoqvmw) = ekkxlnpgxj kmojbvgtsd (wzbglvbfgm, ezjndceapt - idyphkyell) View more	-	11 Jan 2021
				placebo (Placebo)	sbhscivaiz(cqhizoqvmw) = sxhkyrpvbh kmojbvgtsd (wzbglvbfgm, whlehfefpr - wnstqmdqlt) View more

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