InMed Announces INM-089 Intravitreal Formulation in the Treatment of Dry Age-Related Macular Degeneration
InMed Pharmaceuticals (NASDAQ: INM) has announced the selection of an intravitreal (IVT) formulation for INM-089 as a drug candidate for treating dry age-related macular degeneration (AMD). The company has achieved successful delivery of the formulation at doses up to 10 times the projected therapeutic level, demonstrating a favorable pharmacokinetic profile and significant safety margin.
The company has completed dose-ranging in vivo studies, which will guide the selection of appropriate doses for pivotal preclinical toxicology studies. The INM-089 IVT formulation will proceed to GLP-enabling studies and subsequent clinical development stages. InMed chose intravitreal injection as the delivery method, noting it's the established standard of care among retinal specialists, particularly given the challenges of delivering lipophilic drugs through topical formulations like eye drops.
InMed Pharmaceuticals (NASDAQ: INM) ha annunciato la selezione di una formulazione intravitrea (IVT) per INM-089 come candidato terapeutico per il trattamento della degenerazione maculare secca legata all'età (AMD). L'azienda ha raggiunto una somministrazione efficace della formulazione a dosi fino a 10 volte il livello terapeutico previsto, dimostrando un profilo farmacocinetico favorevole e un significativo margine di sicurezza.
L'azienda ha completato studi in vivo di variazione della dose, che guideranno la selezione delle dosi appropriate per gli studi tossicologici preclinici cruciali. La formulazione IVT di INM-089 procederà agli studi di validazione GLP e ai successivi stadi di sviluppo clinico. InMed ha scelto l'iniezione intravitrea come metodo di somministrazione, notando che è lo standard di cura stabilito tra gli specialisti retinici, specialmente considerando le sfide nel somministrare farmaci lipofili attraverso formulazioni topiche come le gocce oculari.
InMed Pharmaceuticals (NASDAQ: INM) ha anunciado la selección de una formulación intravítrea (IVT) para INM-089 como candidato a medicamento para el tratamiento de la degeneración macular seca relacionada con la edad (AMD). La compañía ha logrado una administración exitosa de la formulación a dosis de hasta 10 veces el nivel terapéutico proyectado, lo que demuestra un perfil farmacocinético favorable y un margen de seguridad significativo.
La compañía ha completado estudios in vivo de rango de dosis, que guiarán la selección de dosis apropiadas para estudios de toxicología preclínica pivotal. La formulación IVT de INM-089 avanzará a estudios que habiliten GLP y a las siguientes etapas de desarrollo clínico. InMed eligió la inyección intravítrea como método de administración, señalando que es el estándar de atención establecido entre los especialistas en retina, especialmente dada la dificultad de administrar medicamentos lipofílicos a través de formulaciones tópicas como las gotas para los ojos.
InMed Pharmaceuticals (NASDAQ: INM)는 INM-089의 유리체 내(INM, IVT) 제형을 노화 관련 건성 황반변성(AMD) 치료 후보 약물로 선택했다고 발표했습니다. 회사는 예정된 치료 수준의 10배에 해당하는 용량까지 제형의 성공적인 전달을 달성했으며, 이는 유리한 약동학적 프로필과 상당한 안전성 여유를 보여줍니다.
회사는 주요 전임상 독성학 연구를 위한 적절한 용량 선택을 안내할 용량 범위 연구를 완료했습니다. INM-089 IVT 제형은 GLP 검증 연구 및 후속 임상 개발 단계로 진행될 것입니다. InMed는 유리체 주사를 전달 방법으로 선택했으며, 이는 특히 안약과 같은 국소 제형을 통해 지질 친화적인 약물을 전달하는 데 있어 어려움이 있음을 감안할 때 망막 전문가들 사이에서 확립된 표준 치료법이라고 언급했습니다.
InMed Pharmaceuticals (NASDAQ: INM) a annoncé la sélection d'une formulation intravitréenne (IVT) pour INM-089 comme candidat médicament pour le traitement de la dégénérescence maculaire sèche liée à l'âge (AMD). L'entreprise a réussi à délivrer la formulation à des doses allant jusqu'à 10 fois le niveau thérapeutique projeté, démontrant un profil pharmacocinétique favorable et une marge de sécurité significative.
L'entreprise a complété des études in vivo pour évaluer la plage de doses, qui guideront la sélection des doses appropriées pour les études de toxicologie précliniques pivot. La formulation IVT d'INM-089 avancera vers des études de validation GLP et les prochaines étapes de développement clinique. InMed a choisi l'injection intravitréenne comme méthode d'administration, notant que c'est le standard de soins établi parmi les spécialistes de la rétine, en particulier compte tenu des défis liés à l'administration de médicaments lipophiles par des formulations topiques comme les gouttes oculaires.
InMed Pharmaceuticals (NASDAQ: INM) hat die Auswahl einer intravitrealen (IVT) Formulierung für INM-089 als Arzneikandidat zur Behandlung der altersbedingten trockenen Makuladegeneration (AMD) bekannt gegeben. Das Unternehmen hat eine erfolgreiche Abgabe der Formulierung in Dosen von bis zu 10-mal dem prognostizierten therapeutischen Niveau erreicht, was ein günstiges pharmakokinetisches Profil und einen signifikanten Sicherheitsabstand zeigt.
Das Unternehmen hat Dosisbereichsstudien in vivo abgeschlossen, die die Auswahl geeigneter Dosen für die entscheidenden präklinischen Toxikologiestudien leiten werden. Die INM-089 IVT-Formulierung wird in GLP-fähige Studien und die anschließenden klinischen Entwicklungsphasen übergehen. InMed wählte die intravitrealen Injektionen als Verabreichungsmethode, da dies der etablierte Standard der Versorgung unter Netzhautspezialisten ist, insbesondere angesichts der Herausforderungen bei der Verabreichung lipophiler Medikamente über topische Formulierungen wie Augentropfen.
- Successful delivery of INM-089 at doses 10x higher than therapeutic level, indicating strong safety margin
- Completion of dose-ranging studies, enabling progression to next development phase
- Demonstrated viable delivery method through established IVT administration
- None.
Insights
The selection of INM-089's intravitreal (IVT) formulation marks a significant milestone in InMed's dry AMD program, with several critical implications for investors:
The demonstrated 10x safety margin above therapeutic levels is particularly noteworthy in ophthalmology drug development. This substantial buffer typically translates to reduced clinical trial risks and improved chances of regulatory success. For context, many ophthalmology drug candidates fail in development due to narrow therapeutic windows.
The successful completion of dose-ranging studies positions INM-089 for GLP-enabling studies - a important step before initiating human trials. This progression follows a well-defined regulatory pathway that typically requires 12-18 months of preclinical work before potential IND filing.
The dry AMD market represents a substantial opportunity, with current treatments primarily focused on the wet form of AMD. The unmet medical need is significant, affecting approximately 85-90% of AMD patients. Successful development of an effective dry AMD treatment could potentially capture a multi-billion dollar market segment.
From a technical perspective, the selection of IVT delivery is strategically sound. While more invasive than topical applications, IVT injection has proven highly effective for retinal drug delivery, as demonstrated by blockbuster drugs like Eylea and Lucentis. The formulation's high therapeutic margin could potentially support extended dosing intervals - a key differentiator in the competitive landscape.
However, investors should note that significant development hurdles remain. The transition to GLP studies and eventual human trials represents substantial technical and financial challenges for a company of InMed's size. The path to market will require significant capital investment and flawless execution of development milestones.
- INM-089 IVT formulation selected for continued development
- Demonstrated successful delivery at doses up to 10 times the projected therapeutic level, indicating a favorable pharmacokinetic profile and a significant safety margin
- Dose ranging studies completed
Vancouver, British Columbia--(Newsfile Corp. - February 3, 2025) - InMed Pharmaceuticals Inc. (NASDAQ: INM) ("InMed" or the "Company"), a pharmaceutical company focused on developing a pipeline of proprietary small molecule drug candidates for diseases with high unmet medical needs, today announced the selection of an intravitreal ('IVT') formulation for INM-089 as a drug candidate to be utilized in the Company's ongoing development program targeting the treatment of dry age-related macular degeneration ('AMD').
Michael Woudenberg, InMed's Chief Operating Officer and Senior Vice President of Chemistry, Manufacturing, and Controls, commented, "We are encouraged by the recent data demonstrating that INM-089 can be successfully delivered as an IVT formulation, offering several advantages for the continued development of this compound in the treatment of dry AMD. The supporting data generated through the IVT formulation underscores its potential as an effective therapeutic approach for this challenging condition."
InMed's proprietary IVT formulation, combined with the INM-089 active pharmaceutical ingredient ('API'), has been successfully delivered to the targeted area of the eye in preclinical studies in doses of up to 10 times the calculated safety margin relative to the therapeutic dose level. This INM-089 IVT formulation will be used in the next stages of preclinical studies, including GLP-enabling studies and subsequent stages of clinical development.
Additionally, InMed has recently completed a series of dose-ranging in vivo studies. The information from the dose-ranging study will guide us in selecting the appropriate doses for the pivotal preclinical toxicology studies.
Intravitreal injection has been the established method for the effective delivery of drugs to the back of the eye and remains the standard of care among retinal specialists. Topical formulations, such as eye drops, face significant challenges in delivering highly lipophilic drugs to this target tissue because the complex anatomy and protective barriers of the eye hinder effective drug permeation.
About AMD and need for new treatment options
AMD is a common progressive eye disease affecting the macula, or back of the eye, and impedes one's central vision. An estimated 196 million people worldwide live with AMD. Dry AMD is the most common form, accounting for an estimated
INM-089: A promising drug candidate for Dry AMD
INM-089 is a small molecule drug candidate in development for the treatment of AMD. Preclinical studies of INM-089 demonstrated significant functional and pathological improvements in a dry AMD disease study model. Results from studies demonstrate that INM-089:
- provides neuroprotection of photoreceptors and improves photoreceptor function;
- improves the integrity of the retinal pigment epithelium;
- reduces extracellular auto fluorescent deposits, a hallmark of dry AMD;
- preserves retinal function in the back of the eye; as well as
- improves thickness of "outer nuclear layer" of the retina where photoreceptors are located.
To learn more about InMed's INM-089 Program in the treatment of, please visit our website: https://www.inmedpharma.com/pharmaceutical/inm-089-for-age-related-macular-degeneration/
About InMed:
InMed Pharmaceuticals is a pharmaceutical company focused on developing a pipeline of proprietary small molecule drug candidates targeting the CB1/CB2 receptors. InMed's pipeline consists of three separate programs in the treatment of Alzheimer's, ocular and dermatological indications. For more information, visit www.inmedpharma.com.
Investor Contact:
Colin Clancy
Vice President, Investor Relations
and Corporate Communications
T: +1 604 416 0999
E: ir@inmedpharma.com
Cautionary Note Regarding Forward-Looking Information:
This news release contains "forward-looking information" and "forward-looking statements" (collectively, "forward-looking information") within the meaning of applicable securities laws. Forward-looking statements are frequently, but not always, identified by words such as "expects", "anticipates", "believes", "intends", "potential", "possible", "would" and similar expressions. Such statements, based as they are on current expectations of management, inherently involve numerous risks, uncertainties and assumptions, known and unknown, many of which are beyond our control. Forward-looking information is based on management's current expectations and beliefs and is subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Without limiting the foregoing, forward-looking information in this news release includes, but is not limited to, statements about: the efficacy of INM-089; INM-089's ability to treat AMD; marketability and uses for INM-089; the results of further studies into INM-089 and the further development of InMed's AMD program; and, developing a pipeline of proprietary small molecule drug candidates for diseases with high unmet medical needs.
Additionally, there are known and unknown risk factors which could cause InMed's actual results, performance, or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking information contained herein. A complete discussion of the risks and uncertainties facing InMed's business is disclosed in InMed's Annual Report on Form 10-K and other filings with the Securities and Exchange Commission on www.sec.gov.
All forward-looking information herein is qualified in its entirety by this cautionary statement, and InMed disclaims any obligation to revise or update any such forward-looking information or to publicly announce the result of any revisions to any of the forward-looking information contained herein to reflect future results, events or developments, except as required by law.
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FAQ
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Why did InMed choose intravitreal injection for INM-089 delivery?
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