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InMed Pharmaceuticals Demonstrates INM-901 as an Oral Formulation Targeting Alzheimer's Disease

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InMed Pharmaceuticals (NASDAQ: INM) announces the preclinical success of its proprietary small molecule drug candidate, INM-901, as an oral formulation for Alzheimer's disease. Studies show that orally administered INM-901 achieves therapeutic brain concentrations comparable to intraperitoneal injections over 24 hours. This method may reduce treatment costs and avoid gastrointestinal absorption challenges faced by current large molecule therapies. Further research on drug metabolism, dose responses, and pharmacokinetics is ongoing to support future clinical trials.

InMed Pharmaceuticals (NASDAQ: INM) annuncia il successo preclinico del suo candidato farmaco a piccole molecole proprietario, INM-901, in formulazione orale per la malattia di Alzheimer. Gli studi mostrano che INM-901 somministrato per via orale raggiunge concentrazioni terapeutiche nel cervello paragonabili a quelle delle iniezioni intraperitoneali nell'arco di 24 ore. Questo metodo potrebbe ridurre i costi di trattamento e evitare le sfide relative all'assorbimento gastrointestinale che affrontano le attuali terapie a molecole grandi. Ulteriori ricerche sul metabolismo dei farmaci, le risposte alle dosi e la farmacocinetica sono in corso per supportare i futuri trial clinici.

InMed Pharmaceuticals (NASDAQ: INM) anuncia el éxito preclínico de su candidato a fármaco de molécula pequeña, INM-901, como formulación oral para la enfermedad de Alzheimer. Los estudios muestran que INM-901 administrado por vía oral alcanza concentraciones terapéuticas en el cerebro comparables a las inyecciones intraperitoneales durante 24 horas. Este método podría reducir los costos de tratamiento y evitar los desafíos de absorción gastrointestinal que enfrentan las terapias actuales de moléculas grandes. Se están realizando investigaciones adicionales sobre el metabolismo de los fármacos, las respuestas a las dosis y la farmacocinética para apoyar futuros ensayos clínicos.

InMed Pharmaceuticals (NASDAQ: INM)는 알츠하이머 병을 위한 경구 제형의 독점적인 소분자 약물 후보인 INM-901의 전임상 성공을 발표합니다. 연구에 따르면 경구로 투여된 INM-901은 24시간 동안 복강내 주사와 유사한 치료적 뇌 농도를 달성합니다. 이 방법은 치료 비용을 절감하고 현재의 대분자 치료에서 직면하는 위장관 흡수 문제를 피할 수 있습니다. 향후 임상 시험을 지원하기 위해 약물 대사, 용량 반응 및 약동학에 대한 추가 연구가 진행 중입니다.

InMed Pharmaceuticals (NASDAQ: INM) annonce le succès préclinique de son candidat médicament à petites molécules, INM-901, sous forme orale pour la maladie d'Alzheimer. Des études montrent que l'INM-901 administré par voie orale atteint des concentrations thérapeutiques dans le cerveau comparables à celles des injections intrapéritonéales sur une période de 24 heures. Cette méthode pourrait réduire les coûts de traitement et éviter les problèmes d'absorption gastro-intestinale auxquels font face les thérapies actuelles à grosses molécules. Des recherches supplémentaires sur le métabolisme des médicaments, les réponses aux doses et la pharmacocinétique sont en cours pour soutenir les futurs essais cliniques.

InMed Pharmaceuticals (NASDAQ: INM) gibt den präklinischen Erfolg seines proprietären kleinen Molekül-Arzneimittels INM-901 als orale Formulierung zur Behandlung von Alzheimer bekannt. Studien zeigen, dass oral verabreichtes INM-901 therapeutische Konzentrationen im Gehirn erreicht, die über einen Zeitraum von 24 Stunden mit intraperitonealen Injektionen vergleichbar sind. Dieses Verfahren könnte die Behandlungskosten senken und die Herausforderungen der gastrointestinalen Absorption umgehen, mit denen aktuelle Therapien mit großen Molekülen konfrontiert sind. Weitere Forschungen zu Arzneimittelmetabolismus, Dosiswirkungen und Pharmakokinetik laufen, um zukünftige klinische Studien zu unterstützen.

Positive
  • Successful preclinical demonstration of INM-901 as an oral formulation achieving therapeutic brain concentrations.
  • Potential reduction in treatment delivery costs compared to intravenous methods.
  • INM-901 can cross the blood-brain barrier effectively.
Negative
  • Further studies required to support IND submission, indicating potential delays in clinical trials.

Insights

The development of INM-901 as an oral formulation for Alzheimer's disease is a significant breakthrough. The ability to achieve therapeutic levels in the brain comparable to intraperitoneal injection addresses a major challenge in CNS drug delivery. This could potentially revolutionize Alzheimer's treatment by offering a more patient-friendly and cost-effective alternative to current antibody therapies.

The high bioavailability and ability to cross the blood-brain barrier are important advantages. If successful, this approach could dramatically improve patient compliance and reduce healthcare costs associated with frequent hospital visits for IV infusions. However, it's important to note that while promising, these are still preclinical results and the efficacy and safety in humans remain to be established through rigorous clinical trials.

InMed's progress with INM-901 represents a potentially disruptive innovation in the Alzheimer's treatment landscape. The oral formulation addresses key limitations of current antibody therapies, including delivery challenges, cost and side effects. This could position InMed favorably in the highly competitive Alzheimer's drug market.

However, investors should remain cautious. The path from preclinical studies to FDA approval is long and fraught with risks. Many promising Alzheimer's treatments have failed in later stages. The company's focus on chemistry, manufacturing and controls (CMC) is important for future regulatory submissions. Financial considerations are also important, as drug development is capital-intensive. InMed's ability to fund continued research and potential clinical trials will be critical for long-term success.

  • High bioavailability of INM-901 oral formulation provides similar drug concentration levels in the brain as intraperitoneal (IP) injection

Vancouver, British Columbia--(Newsfile Corp. - August 20, 2024) - 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 confirms INM-901 as an oral formulation that will be utilized in its development programs for Alzheimer's disease.

Recent preclinical studies have demonstrated that INM-901, a proprietary small molecule drug candidate, can be administered orally and achieve therapeutic levels in the brain comparable to those obtained through intraperitoneal ("IP") injection, which is a common route of administration for preclinical investigation of neurodegenerative diseases. The data indicates the INM-901 formulation can be administered orally and maintains a similar drug exposure levels as IP delivery over a 24-hour period in the brain. This oral delivery method offers potential advantages such as reduction in treatment delivery costs versus intravenous delivery of current disease modifying large molecule antibody therapies.

Michael Woudenberg, InMed's Chief Operating Officer and SVP of Chemistry, Manufacturing and Controls ("CMC"), stated, "We are excited by the recent data confirming that INM-901 can be delivered across the blood brain barrier to the brain tissue as an oral formulation which provides significant advantages for further development of this compound in the treatment of Alzheimer's. Similar drug levels in the target tissue are not usually seen between oral versus IP delivery. The supporting data generated by the oral formulation provides an attractive therapeutic approach given the many challenges associated with delivery of drug(s) to the brain."

The administration challenges of current disease-modifying Alzheimer's treatments

Antibodies, which are large molecules, are difficult to formulate orally and present significant challenges to gastrointestinal ("GI") tract absorption and further delivery into the blood stream; therefore, alternative methods of delivery such as IV or subcutaneous injection must be utilized. INM-901 is a small molecule capable of achieving absorption in the GI tract into the blood stream and effectively penetrates the blood-brain barrier.

Current treatment options using large molecules have significant side effects, including inflammation and bleeding in the brain, requiring brain scans once or twice a year to monitor these adverse effects. The frequency of treatment administration, which involves an intravenous infusion at a medical care facility every 2-4 weeks, also presents a challenge. As a result, small molecule drug candidates offer many advantages over currently approved treatment options. InMed's goal is to provide an effective disease-modifying treatment that can be delivered orally, making it widely accessible to patients.

Further development studies ongoing

The Company is conducting further chemistry, manufacturing, and controls for both the drug substance and the drug product formulation, including drug metabolism studies, dose ranging studies and pharmacokinetic studies to support an IND submission.

About INM-901 for the potential treatment of Alzheimer's disease

INM-901 is a small molecule drug candidate being developed as a potential treatment of Alzheimer's disease. INM-901 demonstrates multiple pharmacological effects in preclinical studies including neuroprotective effects, an ability to extend the length of neurites which is important for brain cell-to-cell communication, as well as a reduction in neuroinflammation. These preclinical studies were conducted in well-characterized study models of Alzheimer's disease.

To learn more about INM-901 please visit the website at: https://www.inmedpharma.com/pharmaceutical/inm-901-for-alzheimers-disease/

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. Together with our subsidiary BayMedica, we are a global leader in the manufacturing, development and commercialization of rare cannabinoids and proprietary small molecule drug candidates. 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 formulation of INM-901, the efficacy of INM-901, INM-901's ability to treat AD, marketability and uses for INM-901, the results of further studies into INM-901, as well as CMC studies to support an IND submission.

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 stand-alone 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.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/220490

FAQ

What is INM-901?

INM-901 is a proprietary small molecule drug candidate developed by InMed Pharmaceuticals for treating Alzheimer's disease.

How does INM-901 compare to current Alzheimer's treatments?

INM-901 can be administered orally, achieving similar brain drug levels as intraperitoneal injections, potentially reducing treatment costs and avoiding the challenges of large molecule therapies.

What are the benefits of oral delivery of INM-901?

Oral delivery of INM-901 may reduce treatment delivery costs, improves patient accessibility, and avoids gastrointestinal absorption issues compared to intravenous delivery.

What are the next steps for INM-901's development?

InMed is conducting further studies on drug metabolism, dose responses, and pharmacokinetics to support an IND submission.

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