Modular Medical Announces Results from a Successful GLP-1 Proof of Concept Study
Modular Medical (NASDAQ:MODD) announced successful results from its pre-clinical GLP-1 proof of concept study. The study demonstrated enhanced weight loss and blood glucose control using a pump-delivered rapid-acting GLP-1 with both basal and bolus dosing. The highest basal-bolus dose achieved 17.1% weight loss at 28 days, compared to 13.7% with basal alone. All dosing variations outperformed semaglutide in glucose control. The study involved 5 treatment arms, with semaglutide showing 24.9% weight loss but with a sharp 8% drop in the first two days. The company plans to advance this basal-bolus GLP-1 concept to human trials using their MODD1 device.
Modular Medical (NASDAQ:MODD) ha annunciato risultati positivi dal suo studio pre-clinico di prova di concetto GLP-1. Lo studio ha dimostrato un miglioramento nella perdita di peso e nel controllo della glicemia utilizzando un GLP-1 a rapida azione somministrato tramite pompa, con dosaggi sia basali che bolus. La dose massima combinata basale-bolus ha raggiunto 17,1% di perdita di peso dopo 28 giorni, rispetto al 13,7% con solo il dosaggio basale. Tutte le variazioni di dosaggio hanno superato il semaglutide nel controllo della glicemia. Lo studio ha coinvolto 5 gruppi di trattamento, con il semaglutide che mostrava una perdita di peso del 24,9% ma con un brusco calo dell'8% nei primi due giorni. L'azienda prevede di portare questo concetto di GLP-1 basale-bolus a studi clinici su esseri umani utilizzando il loro dispositivo MODD1.
Modular Medical (NASDAQ:MODD) anunció resultados exitosos de su estudio preclínico de prueba de concepto GLP-1. El estudio demostró una pérdida de peso mejorada y un control de la glucosa en sangre utilizando un GLP-1 de acción rápida administrado mediante bomba, con dosis tanto basales como bolus. La dosis más alta de basal-bolus logró 17.1% de pérdida de peso a los 28 días, en comparación con el 13.7% solo con la dosis basal. Todas las variaciones de dosis superaron al semaglutide en el control de la glucosa. El estudio involucró 5 grupos de tratamiento, donde el semaglutide mostró una pérdida de peso del 24.9% pero con una caída brusca del 8% en los primeros dos días. La empresa planea avanzar este concepto de GLP-1 basal-bolus a ensayos humanos utilizando su dispositivo MODD1.
모듈러 메디컬 (NASDAQ:MODD)은 GLP-1 개념 증명 연구의 전임상 결과를 성공적으로 발표했습니다. 이 연구는 기초 및 볼러스 투여 방식으로 펌프를 통해 전달되는 신속 작용 GLP-1을 사용하여 체중 감소 및 혈당 조절을 향상시켰습니다. 가장 높은 기초-볼러스 용량에서 28일 후 17.1%의 체중 감소를 달성했으며, 이는 단순 기초 투여 시의 13.7%와 비교됩니다. 모든 투여 방식은 혈당 조절에서 세마글루타이드보다 나은 성과를 보였습니다. 이 연구는 5개의 치료군이 참여했으며, 세마글루타이드는 24.9%의 체중 감소를 보여주었지만 처음 2일 동안 8%의 급격한 감소가 있었습니다. 회사는 MODD1 장치를 사용하여 이 기초-볼러스 GLP-1 개념을 인간 시험으로 진행할 계획입니다.
Modular Medical (NASDAQ:MODD) a annoncé des résultats réussis de son étude préclinique de preuve de concept GLP-1. L'étude a démontré une perte de poids améliorée et un contrôle de la glycémie à l'aide d'un GLP-1 à action rapide délivré par pompe, avec des dosages à la fois basaux et bolus. La dose maximale combinée de basal-bolus a atteint 17,1% de perte de poids après 28 jours, contre 13,7% avec uniquement le dosage basal. Toutes les variations de dosage ont dépassé le semaglutide dans le contrôle de la glycémie. L'étude a impliqué 5 bras de traitement, le semaglutide montrant une perte de poids de 24,9% mais avec une forte baisse de 8% au cours des deux premiers jours. L'entreprise prévoit de faire avancer ce concept de GLP-1 basal-bolus vers des essais humains en utilisant leur dispositif MODD1.
Modular Medical (NASDAQ:MODD) hat erfolgreiche Ergebnisse aus seiner präklinischen GLP-1 Machbarkeitsstudie bekannt gegeben. Die Studie zeigte eine verbesserte Gewichtsabnahme und Blutzuckerkontrolle durch die Verwendung eines pumpenbetriebenen, schnell wirkenden GLP-1 mit sowohl Basis- als auch Bolusdosierung. Die höchste Basis-Bolus-Dosis erzielte 17,1% Gewichtsabnahme nach 28 Tagen, verglichen mit 13,7% nur mit Basisdosis. Alle Dosierungsvariationen übertrafen Semaglutid in der Blutzuckerkontrolle. Die Studie umfasste 5 Behandlungsgruppen, wobei Semaglutid eine Gewichtsabnahme von 24,9% zeigte, jedoch einen starken Rückgang von 8% in den ersten zwei Tagen aufwies. Das Unternehmen plant, dieses Konzept des Basis-Bolus-GLP-1 mit ihrem MODD1-Gerät in klinische Studien am Menschen voranzutreiben.
- Successful proof of concept study showing 17.1% weight loss with basal-bolus GLP-1 delivery
- Superior glucose control compared to semaglutide across all dosing variations
- Smoother weight loss initiation compared to semaglutide's aggressive initial drop
- Plans to advance to human trials with MODD1 device
- Weight loss results (17.1%) were lower than semaglutide's overall weight loss (24.9%)
- Pre-clinical stage results may not translate to human trials
Insights
The pre-clinical study results for MODD's GLP-1 pump delivery system show promising potential in the highly competitive weight loss market. The 17.09% weight loss achieved with the basal-bolus combination (
The data suggests two key advantages:
- Enhanced glucose control compared to semaglutide
- More gradual weight loss initiation, potentially improving tolerability
This development positions MODD strategically in the
The planned human trials with the MODD1 device represent a important next step. Success could establish MODD as an innovative player in the rapidly growing obesity treatment market, though significant regulatory hurdles and competition from established players remain key challenges.
-Study showed more potent weight loss and blood glucose control with the addition of a mealtime bolus of a rapid acting GLP-1 to basal delivery
- Observed weight loss was
-Findings suggest that pump delivery may be a viable approach to achieve GLP-1 weight and blood glucose benefits that are comparable with current treatment standards, either as initial treatment or for maintenance, while bringing personalized dosing flexibility
SAN DIEGO, CA / ACCESSWIRE / November 7, 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" with its user-friendly and affordable design, announced successful results from its pre-clinical GLP-1 proof of concept study.
"We are excited by the results of this pre-clinical, proof of concept study in a standard obese mouse model," stated Dr. David Maggs, M.D., medical advisor for this study. "We used a rapid-acting GLP-1 with a short half-life delivered by pump at a continuous basal rate, with several treatment arms adding a moderate additional bolus, just once a day, at the start of the feeding cycle. At the highest basal-bolus dose, we saw a
As expected, none of the rapid acting GLP-1 arms matched the overall weight loss effect of the semaglutide arm. Notably, however, the semaglutide treated mice lost
"With these encouraging results, we are now planning to take this concept of a synergistic basal-bolus GLP-1 combination into a human trial using our MODD1 device. We are considering both existing fast acting GLP-1s and other peptides for this trial, as we see this as a platform technology that could be used for more personalized titration for both non-responder or non-adherent patients experiencing GI and other issues with long acting GLP-1s, as well as for other specialty applications in metabolic therapies. This type of application is well suited for our MODD1 pump, given its quick training time, simple interface, high accuracy at low flow rates, reusable low-cost electronics, and a prefill-capable 3mL reservoir," stated Jeb Besser, CEO of Modular Medical.
While the full details of the study will be presented in subsequent communications, the topline data for weight loss in the diet-induced obese mouse model used is as set forth below.
The study was conducted across 5-arms. Dosing and corresponding body weight loss at 28 days were:
Arm 1: Vehicle / no active drug
Arm 2: 30 mcg basal with 20 mcg bolus once daily
Arm 3: 50 mcg basal only
Arm 4: 50 mcg basal with 20 mcg bolus once daily
Arm 5: Semaglutide bolus daily
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. including but not limited to, whether the Company performs future GLP-1 trials, the potential for ongoing preclinical or clinical trials and results thereof; FDA or other regulatory findings and approvals; potential market opportunities; and the occurrence of future events or circumstances, successful development of Modular Medical's proprietary technologies, whether the market will accept Modular Medical's products and services, anticipated consumer demand for the Company's products, whether Modular Medical can successfully manufacture its products at high volumes, general economic, and 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
What were the weight loss results in Modular Medical's (MODD) GLP-1 study?
How did MODD's GLP-1 delivery compare to semaglutide in blood glucose control?
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