An Endocrine News roundup of the week’s pharmaceutical news, breakthroughs, and general information. *

Metabolon Receives NIH Grant to Develop Advanced Monitoring and Predictive Tools for Type 1 Diabetes Progression

Morrisville, N.C.- based Metabolon, Inc., has received a grant from the National Institutes of Health (NIH) to develop an innovative product aimed at better monitoring and predicting the conversion of preclinical asymptomatic type 1 diabetes to clinical symptomatic, insulin-dependent type 1 diabetes.

Over 3 million people in the United States live with type 1 diabetes. Today, the biomarkers that predict the progression of preclinical type 1 diabetes to clinical type 1 diabetes lack specificity and granularity. Despite advances in medical research, no single FDA-approved test currently can monitor type 1 diabetes progression beyond simple disease staging. Metabolon’s new initiative addresses this unmet need by identifying metabolite biomarkers to improve prediction and enable a more detailed understanding of disease progression when evaluated alongside current clinical indicators.

“Metabolon has a rich history of pioneering advancements in metabolomics. We are dedicated to empowering pharmaceutical and biotechnology companies, as well as academic and government institutions, with comprehensive metabolic insights to drive better health outcomes,” said Ro Hastie, CEO of Metabolon. “With this NIH grant, Metabolon is poised to extend its expertise in type 1 diabetes, aiming to enhance predictive capabilities and improve the lives of millions affected by this condition.”

If successful, Metabolon’s research will enhance the specificity and granularity of type 1 diabetes progression prediction and pave the way for more precise and personalized treatment strategies. By integrating new metabolite biomarkers with existing clinical indicators, Metabolon’s efforts will significantly contribute to diabetes research and patient care.

For more information about Metabolon’s projects and services, please visit: www.metabolon.com.

Teva Launches Authorized Generic Liraglutide Injection in the U.S.

On June 24, Teva Pharmaceuticals, Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd., announced the launch of an authorized generic of Victoza^®1 (liraglutide injection 1.8mg), in the United States.

By launching an authorized generic for Victoza^® (liraglutide injection 1.8mg), we are providing patients with type 2 diabetes another option for this important treatment,” said Ernie Richardsen, SVP, head of U.S. Commercial Generics at Teva. “In addition to strengthening Teva’s diverse complex generics portfolio, we are providing the first generic GLP-1 product to the U.S. marketplace, demonstrating once again our ability to sustain a generics powerhouse.”

What is liraglutide injection?

Liraglutide is an injectable prescription medicine used:

• along with diet and exercise to lower blood sugar (glucose) in adults and children who are 10 years of age and older with type 2 diabetes mellitus.
• to reduce the risk of major cardiovascular events such as heart attack, stroke or death in adults with type 2 diabetes mellitus with known heart disease.

Liraglutide injection 1.8mg is not for use in people with type 1 diabetes. It should not be used with other medicines that contain liraglutide. It is not known if liraglutide injection is safe and effective to lower blood sugar (glucose) in children under 10 years of age.

Endogenex™ to Complete Pivotal Trial of the ReCET™ System in Patients with Type 2 Diabetes

On June 25, Endogenex, a clinical-stage medical device company dedicated to improving outcomes in individuals with type 2 diabetes, announced it has closed an oversubscribed Series C financing totaling $88 million.

The new capital will be used to complete the pivotal ReCET Clinical Study, which has been granted an Investigational Device Exemption (IDE) by the U.S. Food and Drug Administration (FDA).

“We are excited to take this significant step forward in our mission to transform diabetes care,” said Stacey Pugh, CEO of Endogenex. “This funding will enable us to complete our pivotal clinical study, bringing us closer to offering a groundbreaking solution for type 2 diabetes patients. The therapeutic landscape in diabetes continues to evolve, especially around the earlier use of SGLT2i and GLP-1RA. However, there remains a considerable unmet need to address the underlying pathophysiology and progression of the disease.”

“We are very proud of the company’s progress, and this successful funding round is a testament to Endogenex’s innovative technology,” said Juliet Tammenoms Bakker, Endogenex Board Chair and Managing Director at Longitude Capital. “This milestone underscores our investors’ confidence in the company’s vision and the impact it can make in treating the epidemic of type 2 diabetes around the world.”

About the ReCET Clinical Study
The ReCET Clinical Study is a multicenter, prospective, randomized, double-blinded, sham-controlled study assessing the safety and effectiveness of the ReCET System. The pivotal study received IDE approval in November 2023. The study will enroll up to 350 patients at clinical sites in the United States and Australia.

About the ReCET™ Procedure
ReCET is a novel, endoscopic outpatient procedure that targets the cellular pathology of the duodenum. This pathology may contribute to the development and progression of type 2 diabetes.

The ReCET System aims to initiate the body’s natural regenerative process by applying highly controlled, non-thermal pulsed electric fields to the mucosa and sub-mucosa duodenal tissue. This approach may help restore proper cellular signaling from the duodenum and improve metabolic function, including better control of blood glucose levels.

The ReCET System has been evaluated in feasibility clinical studies, such as REGENT-1 US, REGENT-1 Australia, and EMINENT in the Netherlands. These studies assessed the safety and efficacy of the treatment in adults with type 2 diabetes whose blood glucose levels were inadequately controlled despite using insulin and non-insulin medications. Preliminary outcomes from these studies have been presented at medical conferences globally.

The ReCET System has received an FDA Breakthrough Device Designation for treating type 2 diabetes in adults inadequately controlled by glucose-lowering medications.

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