A randomized, double-blind, placebo-controlled investigation to evaluate the performance and safety of SPL7013 Nasal Spray in non-hospitalised patients with COVID-19

Start Date05 Dec 2022

Sponsor / Collaborator-

ACTRN12620001371987

/ CompletedPhase 1

A randomized, double-blind, placebo-controlled investigation of the safety, tolerability and pharmacokinetics of 1% SPL7013 nasal spray in healthy volunteers when administered four times a day for 14 days

Start Date06 Jan 2021

Sponsor / Collaborator

Starpharma Pty Ltd.

NCT02237950

/ CompletedPhase 3

A Phase 3, Double-blind, Multicentre, Randomised, Placebo-controlled Study to Determine the Efficacy and Safety of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis

A double-blind, phase 3 study to determine the efficacy of SPL7013 Gel when administered on alternate days for 16 weeks, compared to placebo gel in preventing the recurrence of BV in women with a history of recurrent BV.

Start Date13 Oct 2014

Sponsor / Collaborator

Starpharma Pty Ltd.

100 Clinical Results associated with Astodrimer sodium

100 Translational Medicine associated with Astodrimer sodium

100 Patents (Medical) associated with Astodrimer sodium

Literatures (Medical) associated with Astodrimer sodium

01 Jul 2022·Archives of gynecology and obstetricsQ4 · MEDICINE

Q4 · MEDICINE

Review

Author: Holzgreve, Wolfgang ; Mendling, Werner

Abstract:

Bacterial vaginosis (BV) is the most common vaginal infection affecting women of childbearing age, and is associated with a substantial burden on women’s physical, emotional, sexual and social lives, as well as being linked to a number of gynaecological and obstetrical complications and adverse pregnancy outcomes. Antibiotics, such as metronidazole or clindamycin, are recommended as first-line treatment for BV, but may be associated with antibiotic resistance, high rates of recurrence and poor patient treatment satisfaction. Astodrimer sodium gel is a novel, non-antibiotic treatment for BV that is not systemically absorbed. It prevents pathogenic bacteria from adhering to the vaginal wall, and disrupts and inhibits the formation of pathogenic bacterial biofilms. Clinical cure rates of 50–57% were observed in patients with BV treated with astodrimer sodium compared with 17–21% treated with placebo (p < 0.001) in Phase 3 trials. In a separate Phase 3 trial, recurrence of BV occurred in 44% of patients treated with astodrimer sodium compared with 54% of patients who received placebo (p = 0.015). Astodrimer sodium is well tolerated, with vulvovaginal candidosis being the only treatment-related adverse event reported to occur more often than with placebo. The availability of astodrimer sodium, a well-tolerated, convenient, non-antibiotic treatment for BV, represents significant progress in the treatment of this burdensome condition.

01 Jul 2021·Antiviral researchQ2 · MEDICINE

Virucidal and antiviral activity of astodrimer sodium against SARS-CoV-2 in vitro

Q2 · MEDICINE

Article

Author: Luscombe, Carolyn A ; Heery, Graham P ; Paull, Jeremy R A ; Castellarnau, Alex ; Fairley, Jacinth K ; Gallay, Philippe A ; Bobardt, Michael D

An effective response to the ongoing coronavirus disease (COVID-19) pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) will involve a range of complementary preventive modalities. The current studies were conducted to evaluate the in vitro SARS-CoV-2 antiviral and virucidal (irreversible) activity of astodrimer sodium, a dendrimer with broad spectrum antimicrobial activity, including against enveloped viruses in in vitro and in vivo models, that is marketed for antiviral and antibacterial applications. We report that astodrimer sodium inhibits replication of SARS-CoV-2 in Vero E6 and Calu-3 cells, with 50% effective concentrations (EC₅₀) for i) reducing virus-induced cytopathic effect of 0.002-0.012 mg/mL in Vero E6 cells, and ii) infectious virus release by plaque assay of 0.019-0.032 mg/mL in Vero E6 cells and 0.030-0.037 mg/mL in Calu-3 cells. The selectivity index (SI) in these assays was as high as 2197. Astodrimer sodium was also virucidal, irreversibly reducing SARS-CoV-2 infectivity by >99.9% (>3 log₁₀) within 1 min of exposure, and up to >99.999% (>5 log₁₀) shown at astodrimer sodium concentrations of 10-30 mg/mL in Vero E6 and Calu-3 cell lines. Astodrimer sodium also inhibited infection in a primary human airway epithelial cell line. The data were similar for all investigations and were consistent with the potent antiviral and virucidal activity of astodrimer sodium being due to irreversible inhibition of virus-host cell interactions, as previously demonstrated for other viruses. Further studies will confirm if astodrimer sodium binds to SARS-CoV-2 spike protein and physically blocks initial attachment of the virus to the host cell. Given the in vitro effectiveness and significantly high SI, astodrimer sodium warrants further investigation for potential as a topically administered agent for SARS-CoV-2 therapeutic applications.

01 Apr 2021·European journal of obstetrics & gynecology and reproductive biology: X

A phase 3, randomized, controlled trial of Astodrimer 1% Gel for preventing recurrent bacterial vaginosis

Article

Author: Agnew, Kathy J ; Waldbaum, Arthur S ; Schwebke, Jane R ; McCloud, Philip ; Castellarnau, Alex ; Kinghorn, George R ; Paull, Jeremy R A ; Price, Clare F ; Carter, Belvia A

OBJECTIVE:

The objective of the study was to confirm the efficacy and safety of Astodrimer 1% Gel to prevent recurrence of bacterial vaginosis.

STUDY DESIGN:

864 women with a diagnosis of bacterial vaginosis and a history of recurrent bacterial vaginosis were enrolled in North America and first received oral metronidazole (500 mg twice daily for 7 days). Women successfully treated with metronidazole were randomly assigned 1:1 to Astodrimer 1% Gel (N = 295) or placebo (N = 291) at a dose of 5 g vaginally every second day for 16 weeks, and followed for a further 12 weeks off-treatment. The primary endpoint was recurrence of bacterial vaginosis (presence of ≥3 Amsel criteria) at or by Week 16. Secondary endpoints included time to recurrence, and recurrence of subject-reported symptoms. Adverse events were monitored throughout the study.

RESULTS:

Astodrimer 1% Gel was superior to placebo for the primary and many secondary efficacy measures. At or by Week 16, bacterial vaginosis recurred in 44.2 % (130/294) of women receiving astodrimer and 54.3 % (158/291) receiving placebo (P = .015). Time to recurrence of bacterial vaginosis was significantly longer for women receiving astodrimer compared with placebo (Kaplan-Meier survival curves, P = .007). Recurrence of subject-reported symptoms at or by Week 16 was also significantly lower in the astodrimer arm compared with placebo (vaginal odor and/or discharge, 27.9 % [75/269] vs 40.6 % [108/266], P = .002). A significantly lower proportion of patients receiving astodrimer compared with placebo had recurrence of bacterial vaginosis at or by Week 16 by other secondary measures, including individual Amsel criteria (vaginal discharge and clue cells) and Nugent score 7-10. Recurrence of subject-reported vaginal odor and/or discharge was significantly lower in the astodrimer arm compared with placebo up to 8 weeks after cessation of therapy (36.1 % [97/269] vs 45.5 % [121/266], P = .027).Adverse events were infrequent, and rates were generally similar between placebo and astodrimer groups. Vulvovaginal candidiasis and urinary tract infection occurred more often in women receiving astodrimer.

CONCLUSIONS:

Astodrimer 1% Gel, administered every second day for 16 weeks, was effective and superior to placebo for prevention of recurrent bacterial vaginosis in women with a history of recurrent BV, and was well-tolerated.

News (Medical) associated with Astodrimer sodium

19 Feb 2024

·firstwordpharma.com

Starpharma ditches plans for US approval of bacterial vaginosis treatment

Starpharma is giving up on obtaining approval of its bacterial vaginosis (BV) treatment in the US - at least for now - after the FDA upheld its call for further clinical data. CEO Cheryl Maley said “whilst we explore opportunities to enter the US market in the future, Starpharma will not prioritise conducting another VivaGel BV clinical trial.”The FDA rejected VivaGel BV in 2018, asking for Starpharma to conduct a confirmatory study despite the application containing data from two Phase III studies that had achieved their primary objective. The company said Monday that as part of a formal dispute resolution process, it made multiple submissions to the agency, provided detailed analyses and regulatory precedents.However, the FDA - which raised no approvability issues with the safety, toxicology, manufacturing or quality aspects of VivaGel BV - maintained its position on the need for another study. Maley explained that Starpharma “has carefully considered and taken account of numerous factors that could affect the outcome of the appeal, including complex regulatory and legal advice, a constantly evolving regulatory landscape, and relatively recent approvals of products used as regulatory precedents.”The executive said the company will now focus on growing VivaGel BV’s sales in countries where it is already approved, including the UK, Europe, Southeast Asia, Australia and New Zealand. More to come.

Phase 3

01 Jul 2022

·www.prnewswire.com

Le spray nasal VIRALEZE™ développé en Australie est relancé par LloydsPharmacy au Royaume-Uni

MELBOURNE, Australie, 1 juillet 2022 /PRNewswire/ -- Les consommateurs britanniques pourront de nouveau acheter VIRALEZE™, un spray nasal barrière facile à utiliser de LloydsPharmacy, après son nouveau lancement en ligne. La disponibilité dans le commerce hors ligne suivra sous peu. Les nombreux tests antiviraux effectués au Scripps Research Institute aux États-Unis, un organisme de renommée mondiale, montrent que VIRALEZE™ est très efficace pour piéger et bloquer un large spectre de virus du rhume et des maladies respiratoires. VIRALEZE™ est homologué dans plus de 30 pays et l'entreprise prévoit de lancer le produit dans un plus grand nombre de marchés. VIRALEZE™ est appuyé par de nombreuses publications dans des revues internationales évaluées par des pairs, et les données ont été présentées à la principale conférence internationale sur les antiviraux, la CROI, plus tôt cette année. Jackie Fairley, PDG de Starpharma, a déclaré : « Nous sommes ravis de relancer le spray nasal innovant de Starpharma, VIRALEZE™, au Royaume-Uni grâce au vaste réseau en ligne et de vente au détail de LloydsPharmacy. VIRALEZE™ sera particulièrement utile pendant la saison hivernale du rhume et de la grippe, étant donné sa capacité à bloquer et à piéger un large éventail de virus du rhume et des maladies respiratoires. Des tests antiviraux approfondis à Scripps montrent que SPL7013, l'agent dans VIRALEZE™, agit contre les virus du rhume et des maladies respiratoires en 30 secondes. » Chaque pulvérisation de VIRALEZE™ dure de quatre à six heures, et le produit peut être utilisé jusqu'à quatre fois par jour avant ou après l'exposition à un virus du rhume ou à un virus respiratoire. Le produit est recommandé pour une utilisation dans des situations où vous pourriez être exposé à des virus du rhume ou à des virus respiratoires, par exemple lors de voyages en avion ou de déplacements en utilisant les transports en commun, ou de visites dans des écoles, des hôpitaux ou tout environnement bondé. Une pulvérisation dans chaque narine fournit une barrière physique dans la cavité nasale, où la densité des récepteurs d'attachement de virus respiratoires est la plus élevée, et où l'infection virale prend le plus souvent racine. [1] La barrière physique de VIRALEZE™ dans le passage nasal piège et bloque les virus du rhume et des voies respiratoires, aidant à réduire leur adhérence, leur multiplication et leur propagation, puis permettant aux défenses naturelles de votre organisme d'éliminer les virus du corps. VIRALEZE™ présente un certain nombre d'avantages uniques, notamment son large spectre, son apparition rapide et sa capacité à piéger et à bloquer les virus du rhume et des voies respiratoires avant ou après l'exposition, fournissant une barrière physique contre les virus du rhume et des voies respiratoires dans la cavité nasale. VIRALEZE™ est disponible en ligne sur le site ci-après : . Le spray sera disponible dans le commerce hors ligne sous peu. SOURCE Starpharma

30 Jun 2022

·www.prnewswire.com

El spray nasal VIRALEZE™ relanzado por LloydsPharmacy en Reino Unido

- El spray nasal VIRALEZE™, desarrollado en Australia, es relanzado por LloydsPharmacy en Reino Unido MELBOURNE, Australia, 30 de junio de 2022 /PRNewswire/ -- Los consumidores del Reino Unido podrán volver a comprar VIRALEZE™, un aerosol nasal de barrera fácil de usar, de LloydsPharmacy, tras su relanzamiento en línea, y su disponibilidad en las tiendas en breve. Las exhaustivas pruebas antivirales llevadas a cabo en el mundialmente conocido Scripps Research Institute de Estados Unidos demuestran que VIRALEZE™ es altamente eficaz para atrapar y bloquear un amplio espectro de virus del resfriado y respiratorios. VIRALEZE™ está registrado en más de 30 países de todo el mundo y la empresa tiene previsto extender el producto a más mercados. VIRALEZE™ está respaldado por múltiples publicaciones en revistas internacionales revisadas por expertos y los datos se presentaron en la principal conferencia internacional sobre antivirales, la CROI, a principios de este año. El consejero delegado de Starpharma, Dr Jackie Fairley, dijo, "Estamos encantados de relanzar el innovador spray nasal de Starpharma, VIRALEZE™, en Reino Unido a través de la amplia red de venta online y minorista de LloydsPharmacy. VIRALEZE™ será especialmente útil en la temporada invernal de gripe y resfriados, dada su capacidad para bloquear y atrapar un amplio espectro de virus respiratorios y del resfriado. Las extensas pruebas antivirales realizadas en Scripps demuestran que SPL7013, el agente de VIRALEZE™, actúa contra los virus del resfriado/respiratorios en 30 segundos". Cada pulverización de VIRALEZE™ dura entre cuatro y seis horas, y el producto puede utilizarse hasta cuatro veces al día antes o después de la exposición a un virus del resfriado o respiratorio. El producto se recomienda para su uso en situaciones en las que se pueda estar expuesto a los virus del resfriado o respiratorios, como viajar en avión o en transporte público, visitar escuelas, hospitales o cualquier entorno concurrido. Una pulverización en cada fosa nasal proporciona una barrera física dentro de la cavidad nasal, donde la densidad de los receptores de fijación de los virus respiratorios es más alta, y donde la infección viral se afianza con mayor frecuencia.[1] La barrera física de VIRALEZE™ en las fosas nasales atrapa y bloquea los virus del resfriado y de las vías respiratorias, ayudando a reducir su adhesión, multiplicación y propagación, y permitiendo que las defensas naturales del organismo eliminen los virus del cuerpo. VIRALEZE™ tiene una serie de ventajas únicas, como su amplio espectro, su rápida aparición y su capacidad para atrapar y bloquear los virus del resfriado/respiratorios antes o después de la exposición, proporcionando una barrera física a los virus del resfriado y respiratorios en la cavidad nasal. VIRALEZE™ se puede encontrar en línea en y estará disponible en tiendas en breve. SOURCE Starpharma

100 Deals associated with Astodrimer sodium

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB11854

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Bacterial Vaginosis	Australia	Starpharma Pty Ltd.	24 Oct 2017

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Herpes Genitalis	Phase 2	Australia	Starpharma Pty Ltd.	01 Aug 2008
HIV Infections	Phase 2	Australia	Starpharma Pty Ltd.	01 Aug 2008

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02237950 (Pubmed) Manual	Phase 3	Bacterial Vaginosis	585	metronidazole+Astodrimer	viuzfzuosc(jvegmnqgaz) = ajrumyhgxs kfcotipnow (jnmyyyfmqg ) View more	Positive	19 Jan 2021
				metronidazole+Placebo	viuzfzuosc(jvegmnqgaz) = kmvziykipx kfcotipnow (jnmyyyfmqg ) View more
NCT01577238 (CTgov)	Phase 3	Bacterial Vaginosis	250	1% SPL7013 Gel (VivaGel)	atlsokhcud = nmtornuauz kbxjdhvduj (qkvespzvxm, zyrhxkfaty - ipvjzbfazp) View more	-	09 Jul 2019
				Placebo (HEC Placebo)	atlsokhcud = xjbfzjbhbh kbxjdhvduj (qkvespzvxm, rplnhglxko - hhkcjnizsd) View more
NCT01577537 (CTgov)	Phase 3	Bacterial Vaginosis	251	1% SPL7013 Gel (VivaGel)	zplnldqffy = cxpwbboyum dwnmxknhow (txgctimjzn, ohrcieieiz - penphntjae) View more	-	09 Jul 2019
				Placebo (HEC Placebo)	zplnldqffy = bcvhkofztb dwnmxknhow (txgctimjzn, garnhrezgo - fltgqqnart) View more
NCT02237950 (CTgov)	Phase 3	Bacterial Vaginosis	586	1% SPL7013 Gel+Metronidazole (1% SPL7013 Gel)	iywmirhdgl = vpaawxfjnx ngqcxwaefr (npxojmxpiq, flpfjvydfk - yuhyytoprh) View more	-	09 Jul 2019
				Placebo gel+Metronidazole (Placebo Gel)	iywmirhdgl = cfzatucoho ngqcxwaefr (npxojmxpiq, udarjpxgce - exqkxuydpy) View more
NCT01201057 (CTgov)	Phase 2	Bacterial Vaginosis	132	0.5% SPL7013 Gel (0.5% SPL7013 Gel)	mwlknakymg = dnrghjmpvy ojpsmsftgf (xzhogmkxvm, acqlcievic - vlzqbhoasg) View more	-	06 Jun 2019
				1.0% SPL7013 Gel (1.0% SPL7013 Gel)	mwlknakymg = lbzhdnaclx ojpsmsftgf (xzhogmkxvm, jcsnplnveu - kaihaogoiu) View more
NCT00740584 (Pubmed \| PLoS One)	Phase 1/2	HIV Infections \| Herpes Simplex	11	SPL7013 Gel (VivaGel)	alcuvxafle(rksprpzzba) = sffywlrvzc vdpuldayjp (gspvbztnmh ) View more	-	01 Jan 2011

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