Modular Medical Announces Finalization of Protocol for GLP-1 Personalized Metabolic Therapy Study Utilizing the MODD1 Platform
Modular Medical (NASDAQ:MODD) has finalized the protocol for a proof-of-concept study exploring the use of its MODD1 pump platform for delivering rapid-acting GLP-1 therapies. The study, set to begin in October 2024 with data expected in November 2024, aims to address issues faced by patients who discontinue long-acting GLP-1 formulations due to tolerability, inconsistent efficacy, and cost.
The company sees potential in using the MODD1 pump for personalized metabolic therapy, particularly for those who struggle with weekly GLP-1 injections. This application would require no significant changes to the MODD1 design. If successful, Modular Medical plans to partner with a drug manufacturer for clearance and marketing.
CEO Jeb Besser will discuss the program details in a Tribe Public Webinar on September 11, 2024. The company believes this new application could be as significant as its base insulin pump business, targeting a market of patients who cannot tolerate weekly therapies.
Modular Medical (NASDAQ:MODD) ha concluso il protocollo per uno studio di proof-of-concept che esplora l'utilizzo della sua piattaforma di pompe MODD1 per la somministrazione di terapie GLP-1 ad azione rapida. Lo studio, che inizierà a ottobre 2024 con dati attesi a novembre 2024, mira ad affrontare i problemi che incontrano i pazienti che interrompono le formulazioni di GLP-1 a lunga durata d'azione a causa della tollerabilità, dell'efficacia incoerente e dei costi.
La società vede un potenziale nell'utilizzo della pompa MODD1 per la terapia metabolica personalizzata, in particolare per coloro che faticano con le iniezioni settimanali di GLP-1. Questa applicazione non richiederebbe cambiamenti significativi nel design del MODD1. Se avrà successo, Modular Medical prevede di collaborare con un produttore di farmaci per l'approvazione e il marketing.
Il CEO Jeb Besser discuterà i dettagli del programma in un webinar pubblico Tribe l'11 settembre 2024. L'azienda crede che questa nuova applicazione possa essere altrettanto significativa quanto il suo business principale delle pompe per insulina, mirando a un mercato di pazienti che non possono tollerare le terapie settimanali.
Modular Medical (NASDAQ:MODD) ha finalizado el protocolo para un estudio de prueba de concepto que explora el uso de su plataforma de bomba MODD1 para la administración de terapias GLP-1 de acción rápida. El estudio, que comenzará en octubre de 2024 con datos esperados en noviembre de 2024, tiene como objetivo abordar los problemas que enfrentan los pacientes que interrumpen las formulaciones de GLP-1 de acción prolongada debido a la tolerancia, eficacia inconsistente y costo.
La empresa ve un potencial en el uso de la bomba MODD1 para la terapia metabólica personalizada, especialmente para aquellos que luchan con las inyecciones semanales de GLP-1. Esta aplicación no requeriría cambios importantes en el diseño del MODD1. Si tiene éxito, Modular Medical planea asociarse con un fabricante de medicamentos para la aprobación y marketing.
El CEO Jeb Besser discutirá los detalles del programa en un webinario público de Tribe el 11 de septiembre de 2024. La empresa cree que esta nueva aplicación podría ser tan significativa como su negocio base de bombas de insulina, dirigido a un mercado de pacientes que no pueden tolerar terapias semanales.
모듈러 메디컬(NASDAQ:MODD)은 개념 증명 연구를 위한 프로토콜을 완료했습니다. 이 연구는 MODD1 펌프 플랫폼을 사용하여 빠르게 작용하는 GLP-1 치료제를 전달하는 것을 탐구합니다. 연구는 2024년 10월에 시작하여 2024년 11월에 데이터가 나올 예정입니다. 이 연구는 내구성이 떨어지는 GLP-1 제제를 중단하는 환자들이 직면하는 문제를 해결하는 것을 목표로 하고 있습니다.
회사는 개인 맞춤형 대사 치료를 위한 MODD1 펌프 사용 가능성을 보고 있으며, 특히 주 1회의 GLP-1 주사에 어려움을 겪는 환자에게 유용할 수 있습니다. 이 응용 프로그램은 MODD1 디자인에 심각한 변경이 필요하지 않습니다. 성공할 경우, 모듈러 메디컬은 약물 제조업체와 파트너십을 통해 승인 및 마케팅을 진행할 계획입니다.
CEO 제브 베서가 2024년 9월 11일에 열리는 Tribe 공개 웨비나에서 프로그램 세부 사항을 논의할 예정입니다. 이 회사는 이 새로운 응용 프로그램이 주간 치료를 견딜 수 없는 환자들을 대상으로 하는 인슐린 펌프 사업만큼이나 중요할 수 있다고 믿고 있습니다.
Modular Medical (NASDAQ:MODD) a finalisé le protocole d'une étude de preuve de concept explorant l'utilisation de sa plateforme de pompe MODD1 pour l'administration de thérapies GLP-1 à action rapide. L'étude, qui devrait commencer en octobre 2024 avec des données attendues en novembre 2024, vise à traiter les problèmes rencontrés par les patients qui interrompent les formulations de GLP-1 à longue action en raison de la tolérance, de l'efficacité incohérente et des coûts.
L'entreprise voit un potentiel dans l'utilisation de la pompe MODD1 pour une thérapie métabolique personnalisée, en particulier pour ceux qui éprouvent des difficultés avec les injections hebdomadaires de GLP-1. Cette application ne nécessiterait pas de modifications significatives du design de MODD1. Si cela réussit, Modular Medical prévoit de s'associer à un fabricant de médicaments pour l'approbation et le marketing.
Le PDG Jeb Besser discutera des détails du programme lors d'un webinaire public Tribe le 11 septembre 2024. L'entreprise estime que cette nouvelle application pourrait être aussi significative que son activité principale de pompes à insuline, visant un marché de patients qui ne peuvent pas tolérer les thérapies hebdomadaires.
Modular Medical (NASDAQ:MODD) hat das Protokoll für eine Machbarkeitsstudie abgeschlossen, die den Einsatz ihrer MODD1-Pumpplattform zur Verabreichung von schnell wirkenden GLP-1-Therapien untersucht. Die Studie, die im Oktober 2024 beginnen soll, mit Daten die im November 2024 erwartet werden, zielt darauf ab, die Probleme von Patienten anzugehen, die langwirkende GLP-1-Formulierungen aufgrund von Verträglichkeit, inkonsistenter Wirksamkeit und Kosten absetzen.
Das Unternehmen sieht Potenzial darin, die MODD1-Pumpe für eine personalisierte Stoffwechseltherapie zu verwenden, insbesondere für diejenigen, die Schwierigkeiten mit wöchentlichen GLP-1-Injektionen haben. Diese Anwendung würde keine wesentlichen Änderungen am Design der MODD1 erfordern. Bei Erfolg plant Modular Medical eine Partnerschaft mit einem Arzneimittelhersteller für Genehmigung und Marketing.
CEO Jeb Besser wird die Programmdetails in einem öffentlichen Tribe-Webinar am 11. September 2024 besprechen. Das Unternehmen glaubt, dass diese neue Anwendung ebenso bedeutend sein könnte wie ihr Kernbereich des Insulinpumpenmarktes, der sich an Patienten richtet, die wöchentliche Therapien nicht vertragen können.
- FDA clearance for MODD1 pump enhances company credibility for exploring new applications
- Potential to expand into GLP-1 therapy market without significant product modifications
- Possible partnership opportunity with drug manufacturers for future development
- Addressing a large market of patients who discontinue long-acting GLP-1 therapies
- Results of the proof-of-concept study are uncertain and may not yield positive outcomes
- Potential distraction from the company's primary focus on insulin delivery for 'almost-pumpers'
- Success depends on demonstrating comparable efficacy to existing GLP-1 therapies with fewer side effects
Modular Medical's exploration of GLP-1 delivery via their MODD1 pump platform is an intriguing development in metabolic therapy. The planned study, targeting patients who discontinue long-acting GLP-1 formulations, addresses a significant market need. With
This news presents a strategic pivot for Modular Medical, potentially expanding their addressable market beyond diabetes care. The GLP-1 market is booming, with drugs like Ozempic and Wegovy in high demand. By targeting patients who discontinue long-acting GLP-1 therapies, MODD is addressing a significant unmet need. If successful, this could open up a market potentially as large as their base insulin pump business. However, investors should note that this is still in early stages, with the study not starting until October 2024. The company's strategy to potentially partner with a drug manufacturer for clearance and marketing is prudent, given the regulatory complexities. While promising, this venture represents a speculative long-term play rather than an immediate revenue driver.
From a financial perspective, this announcement represents a potential value creation opportunity for Modular Medical. Expanding into the GLP-1 market could significantly broaden the company's revenue streams. However, investors should exercise caution. The study is still in its early stages, with results not expected until November 2024. Even if successful, bringing a new GLP-1 delivery system to market would require substantial investment in R&D and regulatory processes. The strategy to partner with a drug manufacturer could mitigate some financial risks, but terms of such partnerships are yet unknown. While this news doesn't immediately impact the company's financials, it does demonstrate management's focus on long-term growth and innovation. Investors should monitor the study results closely, as positive outcomes could potentially drive future valuation.
-Proof of Concept Study in Rapid Acting GLP-1 to commence in October 2024 with data expected in November 2024
-Pre-clinical study to explore use of MODD1 pump as a personalized delivery system for people who discontinue long-acting GLP-1 formulations
-CEO to discuss further details of the program in Tribe Public Webinar on Wednesday, September 11 at 8:30 a.m. Pacific time
SAN DIEGO, CA / ACCESSWIRE / September 11, 2024 / Modular Medical, Inc. (NASDAQ:MODD) ("Modular Medical" or the "Company"), an insulin delivery technology company with the first FDA-cleared patch pump designed specifically to target all adult "almost-pumpers" thanks to its user friendly and affordable design, today announced an update on its proof-of-concept study in a high-fat diet-induced obese ("DIO") mouse model to explore the potential future use of the MODD1 pump platform to assist patients who struggle with tolerability, inconsistent efficacy, and cost of long acting GLP-1 therapies. The Company has finalized its protocol for the proof-of concept study, which is now expected to commence in October 2024 with data readout in November 2024.
"We see the MODD1 as a transformative platform with many different applications outside of diabetes care, and, with our US Food and Drug Administration ("FDA") clearance in hand, we now have the credibility in the market to explore other use cases without distracting from our primary focus of improving care for the "almost pumpers," stated Jeb Besser, CEO of Modular Medical.
"Our first effort in this regard will be the data readout in November of our proof-of-concept study using a rapid acting GLP1 to treat those who are unable to tolerate once weekly shots. This program would require no material changes to our basic MODD1 design, and, if we can demonstrate good glycemic control and weight loss efficacy with fewer GI side effects than the once weekly shots, we believe the market for those who cannot tolerate the one size fits all weekly therapies is potentially as large as our base insulin pump business. If successful, this is a project we would ultimately seek to partner with a drug manufacturer that would take lead on clearance and marketing.
"As a reminder, a recent study published by Blue Health Intelligence using data from a national dataset of private insurers found that about half of all patients prescribed a GLP-1 drug for weight loss discontinued after the first 12 weeks. These discontinuations appear to be due to a combination of tolerability, cost, and inconsistent efficacy. We suspect that shorter-acting peptides may mitigate many of these side effects and dosage swings by better modulating dosage, but these therapies have generally been abandoned as "too difficult to use" because they required multiple doses per day to be effective. We see the potential for such dosing regimes to be greatly simplified and even improved by the use of our low cost, easy to learn pump technology to provide both a basal dose and boluses to control hunger. MODD will seek to determine whether an existing FDA approved short-acting peptide delivered from a pump platform can provide a more personalized and more tolerable solution for patients who found long acting GLP-1 drugs too difficult to tolerate, while delivering comparable glycemic control and weight loss, specifically for people with type 2 diabetes and obesity.
"With the recent clearance of our MODD1 pump by the FDA for the delivery of insulin in all adults, which has similar demands to this prospective application in accuracy and volumes to be potentially delivered, we have additional credibility, as we explore other ways to impact care to further our mission of diabetes care for the rest of us."
Mr. Besser will further discuss the rationale for this program in a webinar hosted by Tribe Public at 8:30 a.m. Pacific time on Wednesday, September 11, 2024. To register to join the complimentary event, please visit the Tribe Public LLC at MODD-GLP-1.TribePublic.com
Forward-Looking Statements
This press release contains forward-looking statements that are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are subject to risks, trends, and uncertainties that could cause actual results to be materially different from the forward-looking statements contained in this press release. These factors include, but are not limited to, the expected timing of the proof-of concept study for GLP-1 therapies, the expected timing of commercial availability for the Company's MODD1 product, Modular Medical's ability to obtain foreign government approvals for its MODD1 product, whether Modular Medical can successfully develop its proprietary technologies, whether the market will accept Modular Medical's products and services, the future product roadmap and development activities, anticipated consumer demand for its products, whether Modular Medical can successfully manufacture its products at high volumes, general economic, industry or political conditions in the United States or internationally as well as other risk factors and business considerations described in Modular Medical's SEC filings, including its annual report on Form 10-K. Any forward-looking statements in this press release should be evaluated in light of these important risk factors. In addition, any forward-looking statements included in this press release represent Modular Medical's views only as of the date of its publication and should not be relied upon as representing its views as of any subsequent date. Modular Medical assumes no obligation to update these forward-looking statements, except as required by law.
About Modular Medical
Modular Medical, Inc. (NASDAQ:MODD) is a development-stage medical device company that intends to launch the next generation of insulin delivery technology. Using its patented technologies, the company seeks to eliminate the tradeoff between complexity and efficacy, thereby making top quality insulin delivery both affordable and simple to learn. Our mission is to improve access to the highest standard of glycemic control for people with diabetes taking it beyond "superusers" and providing "diabetes care for the rest of us."
Modular Medical was founded by Paul DiPerna, a seasoned medical device professional and microfluidics engineer. Prior to founding Modular Medical, Mr. DiPerna was the founder (in 2005) of Tandem Diabetes and invented and designed its t:slim insulin pump. More information is available at https://modular-medical.com.
All trademarks mentioned herein are the property of their respective owners.
CONTACT:
Jeb Besser
Chief Executive Officer
Modular Medical, Inc.
+1 (617) 399-1741
IR@modular-medical.com
SOURCE: Modular Medical, Inc.
View the original press release on accesswire.com
FAQ
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