Delving into the Latest Updates on Netakimab with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Anti-IL-17-monoclonal-antibody-Biocad, Anti-interleukin-17-monoclonal-antibody-Biocad, Efleira

+ [2]

Target

IL-17A

Action

inhibitors

Mechanism

IL-17A inhibitors(Interleukin 17A inhibitors)

Therapeutic Areas

Immune System DiseasesInfectious DiseasesSkin and Musculoskeletal Diseases

Active Indication

PsoriasisArthritis, PsoriaticAnkylosing Spondylitis+ [1]

Inactive Indication

Primary Biliary Cholangitis

Originator Organization

Biocad Medical, Inc.

Active Organization

Biocad CJSCShangyao Bokang Biomedical (Shanghai) Co., Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

Russia (04 Apr 2019),

Arthritis, Psoriatic

Regulation-

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Structure/Sequence

Sequence Code 19692291H

Source: *****

Sequence Code 19692299L

Source: *****

IL-17A, referred to as IL-17, is the founding member of a family of pro-inflammatory cytokines, including IL-17B, IL-17C, IL-17D, IL-17E (or IL-25), and IL-17F, which act via receptors IL-17RA to IL-17RE, and elicit potent cellular responses that impact diverse diseases. IL-17's interactions with various cytokines include forming a heterodimer with IL-17F and being stimulated by IL-23's activation of Th17 cells, which can lead to inflammation and autoimmunity. IL-17 is implicated in infectious diseases and inflammatory disorders such as rheumatoid arthritis and psoriasis, promoting neutrophil recruitment and anti-bacterial immunity, but potentially exacerbating fungal and viral infections, revealing its dual role as protective and pathologic. IL-17 is also involved in various cancers, including breast, colon, cervical, prostate, and skin cancer, contributing to proliferation, immune invasion, and metastases, but also playing a protective role in certain instances. Four FDA-approved drugs-secukinumab (for ankylosing spondylitis, enthesitis-related arthritis, hidradenitis suppurativa, non-radiographic axial spondyloarthritis, plaque psoriasis, and psoriatic arthritis), ixekizumab (for ankylosing spondylitis, non-radiographic axial spondyloarthritis, plaque psoriasis, and psoriatic arthritis), brodalumab (for plaque psoriasis), and bimekizumab (for plaque psoriasis)-suppress the IL-17 pathway, with more in development, including netakimab, sonelokimab, izokibep, and CJM112. These agents and others are being studied across a spectrum of disorders. Understanding the complicated interplay between IL-17 and other immune mediators may yield new treatments for inflammatory/autoimmune conditions and malignancies.

01 Feb 2023·Georgian medical news

NEUROPROTECTIVE AND ANTIOXIDANT POTENTIAL OF MONTELUKAST-ACETYLCYSTEINE COMBINATION THERAPY FOR BRAIN PROTECTION IN PATIENTS WITH COVID-19 INDUCED PNEUMONIA.

Article

Author: Kandelaki, M ; Baratashvili, N ; Samsonia, M ; Gvaramia, L

Direct critical attack of the coronavirus on the alveoli and the excessive release of a large number of cytokines (IL-6, IL-1, TNF-α, etc.) provides suitable conditions for the further development of acute respiratory distress syndrome (ARDS) and severe acute respiratory failure. Serious decrease in blood oxygenation often lead to the deterioration of macro- and microcirculation, irreversible brain damage and hence, persistent neurological and mental disorders despite background intensive therapy and adequate respiratory support. Therefore, the aim of our open prospective observational study was to investigate the neuroprotective and antioxidant effectiveness of montelukast-acetylcysteine combination therapy for brain protection in patients with COVID-19 viral pneumonia. A study was performed for five hundred seventy-eight (n=578) outpatients who were tested positive for novel coronavirus (SARS-CoV-2) by nasopharyngeal swap. The median age of patients was 62±17.45 years. In addition to clinical features and RT-PCR results, chest CT and chest X-ray (CXR) with high sensitivity were also very helpful for the early identification of viral pneumonia and COVID-19 disease assessment. Considering the severity of Covid-19 pneumonia and the level of arterial oxygen saturation (transcutaneous hemoglobin oxygen saturation) on room air, all patients were divided into three major groups. Group 1 (n=288) consisted of patients with a mild shift in oxygen saturation (SpO2 ≥ 95%) and well-defined pulmonary lesions (within 1-2 segments) without concomitant diseases; the second group (Group 2, n=250) included patients with clinical manifestations of moderate severity associated with a current saturation of 90-95% (SpO2) and small pulmonary lesions on chest X-ray in the presence of concomitant diseases: arterial hypertension (stage III) or CHF (FC/NYHA-2), coronary heart disease or type 2 diabetes, cancer, tuberculosis, etc. Most of the patients in third group (Group 3, n=48), during imaging studies, showed bilateral lung affection with low and peripheral distribution (with both - either ground glass opacities or multiple pulmonary nodules) and cardiomegaly. The respiratory failure of stage II-III (current oxygen saturation SpO2 75-90%), high respiratory rate (≥25 per minute), hemodynamic impairment (BP≤100/60 mm Hg. Art., heart rate ≥125/min) were the most common objective clinical findings seen in this subset of patients. Laboratory changes included leukopenia less than 4.0x109/L or leukocytosis (≥10.0X109/L). Background respiratory support with low-flow oxygen therapy and combined pharmacotherapy, where, along with montelukast and acetylcysteine, patients were prescribed a cephalosporin, a fluoroquinolone, an antifungal drug, a histamine blocker, an antiplatelet agent, a complex of B vitamins, led to a significant improvement in symptoms and laboratory parameters during the course of the disease. The mean values of the blood biomarkers (CRP - 21.46±4.43 mg/l, LDH - 410.71±40.63 U/l, procalcitonin - 1.08±0.31 ng/ml, and ferritin - 270.43±27.23 ng/ml) return to normal by the 20th day after the fever subsides. Laboratory parameters before and after treatment course showed statistically significant differences between variables (p<0.05). No patient in Group 3 received JAK inhibitors (tofacitinib and baricitinib), IL-6 (olokizumab), IL-17A (netakimab) and glucocorticosteroids, however, recovery rates were completely good. Assessment of the patient's neurological status (based on the NIHSS scores) revealed no signs of neurological changes. Thus, based on the data given, it can be concluded that the high efficacy of the acetylcysteine/montelukast combination (as neuroprotectors) in pneumonia caused by COVID-19 is due to the effect of drugs on key mechanisms of pathogenesis: reduction of oxidative stress as drugs (combination) ensuring the free radical scavenging; stimulation of glutathione synthesis; suppression of cytokine storm; reduction of bronchospasm, mucus secretion and airway edema; lowering of BBB permeability and the ability to improve cerebral microcirculatory perfusion in the presence of antiplatelet agents. In conclusion, the combination of montelukast and acetylcysteine may provide an effective, safe, multicomponent approach to the prevention of hypoxic brain injury in patients with COVID-19 pneumonia.

02 Dec 2022·Expert Opinion on Biological Therapy

Biological treatment for erythrodermic psoriasis

Review

Author: Mehta, Hitaishi ; Dogra, Sunil

INTRODUCTIONErythrodermic psoriasis (EP) is an extreme and potentially life-threatening form of psoriasis in which most or all of the body surface area is affected by psoriasis. It occurs in 1-2% of patients with psoriasis and is less responsive to conventional therapies. Biologics have shown promise in the management of EP.AREAS COVEREDThis review briefly discusses the pathophysiology of EP. Current evidence on established and emerging targeted therapies for EP is covered, including anti-TNF-α biologics, IL-12/23, IL-17, and IL-23 inhibitors.EXPERT OPINIONThe need for rapidly acting, safe, and efficacious agents in EP has been met with advent of newer biologics, particularly IL-17 and IL-23 inhibitors. These targeted approaches warrant consideration as first-line management option for the management of EP; however, high-quality evidence regarding their long-term efficacy and safety in EP is lacking. Novel biologics such as bimekizumab and mirikizumab, and nanobodies such as netakimab and sonelokimab have shown promise in the management of plaque psoriasis, and potential of these molecules in management of EP should be explored. Management of patients with prior biologic failure remains a challenge. Guidelines for the management of EP need to be revisited in light of the recent advances.

100 Deals associated with Netakimab

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External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Psoriasis	Russia	Biocad CJSC	01 May 2019
Arthritis, Psoriatic	Russia	Biocad CJSC	04 Apr 2019

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Ankylosing Spondylitis	Phase 3	Russia	Biocad CJSC	09 Feb 2018
Plaque psoriasis	Phase 3	Russia	Biocad CJSC	26 Dec 2017
Primary Biliary Cholangitis	Phase 2	Russia	Biocad CJSC	27 Apr 2018
Arthritis, Psoriatic	Preclinical	Belarus	Biocad CJSC	25 Jul 2018

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03447704 (ASTERA, EULAR2021)	Phase 3	Ankylosing Spondylitis	-	Netakimab 120 mg	idbczpszso(urwexmzqre) = nrlteefxmu vcwjfaiopr (oegtgcjudn ) View more	-	02 Jun 2021
				Placebo	idbczpszso(urwexmzqre) = iusftvximz vcwjfaiopr (oegtgcjudn ) View more
NCT03390101 (PLANETA \| BCD-085-7, CTgov)	Phase 3	Plaque psoriasis	213	BCD-085 Q2W (BCD-085 Q2W)	tjlxnaosyf(scwifkhnbq) = utjgwhbzzl ukbuflijao (dmifhfthqn, fqngmzhuht - avmrdgvbfl) View more	-	11 May 2021
				BCD-085 Q4W (BCD-085 Q4W)	tjlxnaosyf(scwifkhnbq) = acldygiqgh ukbuflijao (dmifhfthqn, ebaxwmbfwb - uyccxkcyax) View more
NCT02762994 (CTgov)	Phase 2	Plaque psoriasis	120	BCD-085 (BCD-085, 40 mg)	ywjbdiowax(xzjhsoxyni) = irbulztktq icrdbbdtby (cnjelrvhnj, ytkpzibvvo - chvgacjbdg) View more	-	23 Mar 2021
				BCD-085 (BCD-085, 80 mg)	ywjbdiowax(xzjhsoxyni) = zjzazegfqh icrdbbdtby (cnjelrvhnj, ltlrmlvwbu - chtkrshdmf) View more
NCT03598751 (PATERA, EULAR2020)	Phase 3	Arthritis, Psoriatic	194	Netakimab 120mg	(kxbmzcjdvh) = rzjzvdkjue ueicbtzrkd (akjyysudfe )	Positive	03 Jun 2020
				Placebo	(kxbmzcjdvh) = pmpusaziwy ueicbtzrkd (akjyysudfe )
NCT03598751 (PATERA, EULAR2020)	Phase 3	Arthritis, Psoriatic	194	Netakimab 120mg	kyqndnxpgs(azzdoignbw) = iifxyptylw fmuwqlfodt (tucxeemayh, 32.83) View more	-	03 Jun 2020
				Placebo	kyqndnxpgs(azzdoignbw) = yjgjlizrch fmuwqlfodt (tucxeemayh, 63.48) View more
NCT03598751 (PATERA, EULAR2020)	Phase 3	Arthritis, Psoriatic	194	Netakimab 120 mg	hyrdvgetuv(udskssgqnk) = snoafkvazw puxuzoguag (kybzuueqku, 29.1)	Positive	03 Jun 2020
				Placebo	hyrdvgetuv(udskssgqnk) = fflxwyjhiw puxuzoguag (kybzuueqku, 31.8)
NCT02763111 (Pubmed) Manual	Phase 2	Ankylosing Spondylitis	89	netakimab	(zdjfarpehm) = fwfqbwvuom vzfozikofj (uhfaaugfcp ) View more	Positive	01 Jan 2020
				Placebo	cpzejdgocf(bzhaprghds) = rjipyojdkh elunaykyxw (zbwmbtbylw )
NCT03447704 (ASTERA, EULAR2019)	Phase 3	Axial Spondyloarthritis IL-17	228	Netakimab	(oqbprbkyqz) = dfrvnlwcxv njxbhfgcby (sixknmlnaq )	Positive	12 Jun 2019
				Placebo	(oqbprbkyqz) = fjfxqrbuok njxbhfgcby (sixknmlnaq )
NCT03447704 (ASTERA, EULAR2019)	Phase 3	Axial Spondyloarthritis	228	Netakimab 120 mg	(rygzlhvuze) = mjlehavudm eplbqnnzdh (drsibjtzwu )	Positive	12 Jun 2019
				Placebo	(rygzlhvuze) = ieavkxhazo eplbqnnzdh (drsibjtzwu )
BCD-085 (EULAR2016)	Phase 1	-	22	BCD-085	(ffanzzuxum) = vbnueftgkj ynxhkhuvrr (tboytkyrxz ) View more	Positive	08 Jun 2016

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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Netakimab

Overview

Basic Info

Structure/Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Biosimilar

Regulation