Modular Medical Announces Proof-of-Concept Study for Personalized Metabolic Therapy utilizing the MODD1 Platform

Rhea-AI Summary

Modular Medical (NASDAQ:MODD) has announced a proof-of-concept study with Gubra A/S to explore the potential use of its MODD1 pump platform for delivering short-acting peptides as an alternative for patients who discontinue long-acting GLP-1 formulations. The study will use a high-fat, diet-induced obese (DIO) mouse model to determine if an FDA-approved, short-acting peptide delivered via pump can provide comparable glycemic control and weight loss with improved tolerability for people with type 2 diabetes and obesity.

This research aims to address the high discontinuation rates of GLP-1 drugs due to tolerability issues, cost, and inconsistent efficacy. Modular Medical believes that pump technology could simplify and improve dosing regimens for short-acting peptides, potentially offering a more personalized and tolerable solution for patients who struggle with long-acting GLP-1 therapies.

Positive

• Potential expansion of MODD1 pump platform applications beyond insulin delivery
• Addressing high discontinuation rates of GLP-1 drugs (50% after 12 weeks, 30% in first 4 weeks)
• Collaboration with Gubra A/S for proof-of-concept study using gold-standard DIO mouse model
• Potential to offer a more personalized and tolerable alternative for patients with type 2 diabetes and obesity

Negative

• Study is in pre-clinical stage, with no guaranteed success or timeline for potential commercialization
• Potential competition from established long-acting GLP-1 therapies in the market

Healthcare Analyst

Modular Medical's announcement of a proof-of-concept study in partnership with Gubra A/S to explore personalized metabolic therapy using the MODD1 platform signals a potentially significant development in diabetes and obesity management. The focus on short-acting peptides to address issues with long-acting GLP-1 formulations is particularly noteworthy. These peptides have previously been deemed impractical due to the need for multiple daily doses. However, integrating these peptides into a pump system like MODD1 could simplify dosing and enhance patient compliance.

This approach aligns well with recent industry trends prioritizing personalized medicine and patient-centric solutions. The use of Gubra's DIO mouse model adds credibility to the study, given its established role in obesity research. Should the study yield positive results, Modular Medical could offer a novel solution that addresses the cost, efficacy and tolerability issues plaguing current long-acting therapies.

From a healthcare perspective, the potential for improved patient adherence and outcomes could make this technology a valuable addition to treatment options for type 2 diabetes and obesity. However, it is important to await clinical trial results before drawing definitive conclusions. Short-acting peptides must demonstrate comparable glycemic control and weight loss outcomes to their long-acting counterparts to be viable alternatives.

Financial Analyst

The initiation of a proof-of-concept study by Modular Medical has implications for the company's financial outlook. The potential to introduce a new, patient-friendly insulin pump that addresses the shortcomings of long-acting GLP-1 therapies could open up new revenue streams and market opportunities. The statistics provided, such as a 50 discontinuation rate of GLP-1 drugs within the first 12 weeks, highlight a significant market gap that Modular Medical aims to fill.

Investors should note the strategic partnership with Gubra, a well-regarded entity in the field of metabolic disease research. This collaboration not only lends scientific credibility but also potentially accelerates the path to market, reducing time and cost associated with in-house development.

However, investors must also consider the risks. The project is still in the pre-clinical stage and success is not guaranteed. The financial benefits will materialize only if the study progresses to human trials and eventually receives FDA approval. Investors should keep an eye on key milestones and regulatory updates that will impact the stock's performance.

In the short term, the announcement may bolster investor sentiment and stock prices due to the promising nature of the research. In the long term, the financial viability hinges on successful clinical outcomes and market adoption.

Pre-clinical study to explore use of MODD1 pump as a delivery system for FDA-approved, short acting peptides, as a personalized alternative for people who discontinue long-acting GLP-1 formulations

SAN DIEGO, CA / ACCESSWIRE / July 15, 2024 / Modular Medical, Inc. (NASDAQ:MODD) ("Modular Medical" or the "Company"), an insulin delivery technology company seeking to launch the next generation of user-friendly and affordable insulin pump technology, today announced a proof-of-concept study with Gubra A/S ("Gubra") 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.

"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, with approximately 30% discontinuing in the first four weeks," commented Jeb Besser, Chief Executive Officer of Modular Medical. "These discontinuations appear to be due to a combination of tolerability, cost, and inconsistent efficacy. We suspect that short-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 pump technology to provide both a basal dose and boluses to control hunger. Using Gubra's gold-standard DIO mouse model, 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."

Michael Feigh, PhD, Vice President, Scientific Research & Sales of Gubra, commented, "We're happy that our expertise and disease specific models are used in the assessment of Modular Medical's novel approach to peptide therapy in diabetes and obesity."

Modular Medical is focused on the delivery of therapeutics using patented technology with greater simplicity, lower cost and a differentiated form factor. "While long acting GLP-1 injectables have shown great results in the management of metabolic disease, we believe this research has the potential to help patients who would otherwise lose out on realizing those important clinical benefits," commented Paul DiPerna, Chairman and President of Modular Medical. "Our simple to learn platform, basal and bolus features, and large prefill-ready reservoir make the MODD1 an ideal candidate for this potential application, once again furthering our mission of diabetes care for the rest of us."

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, Modular Medical's ability to obtain FDA clearance and 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 Gubra

Gubra A/S (Copenhagen: GUBRA) is a highly specialized preclinical CRO and biotech company focused on peptide-based drug discovery within metabolic and fibrotic diseases. The combination of our clinically translatable models and technologies ensures rapid turnaround time and conclusive data.

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 is the purpose of Modular Medical's proof-of-concept study with Gubra A/S?

The study aims to explore the potential use of Modular Medical's MODD1 pump platform for delivering short-acting peptides as an alternative for patients who discontinue long-acting GLP-1 formulations, potentially offering improved tolerability and efficacy for type 2 diabetes and obesity treatment.

How does Modular Medical (MODD) plan to address the high discontinuation rates of GLP-1 drugs?

Modular Medical plans to use its MODD1 pump platform to deliver short-acting peptides, which may offer better dosage modulation and potentially mitigate side effects and dosage swings associated with long-acting GLP-1 drugs, addressing issues of tolerability, cost, and inconsistent efficacy.

What are the potential benefits of using the MODD1 pump for delivering short-acting peptides?

The MODD1 pump could simplify dosing regimens for short-acting peptides, providing both basal and bolus doses to control hunger, potentially offering a more personalized and tolerable solution for patients who struggle with long-acting GLP-1 therapies while delivering comparable glycemic control and weight loss.

When did Modular Medical (MODD) announce its proof-of-concept study for personalized metabolic therapy?

Modular Medical announced the proof-of-concept study on July 15, 2024, as stated in the press release.