Recruitment milestone reached in Diamyd® Phase 3 trial

STOCKHOLM, April 12, 2024 - Diamyd Medical’s precision medicine Phase 3 trial for Type 1 Diabetes, DIAGNODE-3, has enrolled 100 patients. To date, no serious adverse events have been reported, and no patients have discontinued the trial.

“This is an important milestone in our Phase 3 trial and the notable zero dropout rate confirms our insights from previous trials regarding the safety and convinience of the treatment,” says Ulf Hannelius, President & CEO of Diamyd Medical. “We are deeply grateful to our participants for their continued commitment to the trial and to the dedicated staff at our participating clinics for their relentless efforts.”

DIAGNODE-3, being the first ever precision medicine Phase 3 trial in type 1 diabetes, is ongoing in eight European countries and in the United States. The trial specifically enrols patients that carry the genetic HLA DR3-DQ2 haplotype, a genetic subgroup of type 1 diabetes that in previous trials has been associated with positive clinical response to Diamyd® treatment. The antigen-specific immunotherapy Diamyd® was in February 2024 granted Fast Track designation by the FDA and has previously been granted Orphan Drug designation in the U.S.

About DIAGNODE-3

The confirmatory Phase III trial DIAGNODE-3 (www.diagnode-3.com), evaluating the safety and efficacy of the antigen-specific immunotherapy Diamyd® in individuals diagnosed with Type 1 Diabetes is ongoing in the United States and in eight European countries: Sweden, Spain, the Czech Republic, the Netherlands, Germany, Poland, Hungary and Estonia.

DIAGNODE-3 will enroll up to 330 individuals aged 12 to 29 years, recently diagnosed (within 6 months) with Type 1 Diabetes, who carry the HLA DR3-DQ2 haplotype, a certain genetic risk factor for Type 1 Diabetes. A further stratification for HLA haplotypes is included in order to evaluate the potential super responder group of individuals who are positive for HLA DR3-DQ2 and negative for HLA DR4-DQ8. HLA testing is well established and widely available.

This patient population is based on clinical efficacy and safety results from the Phase IIa and Phase IIb trials DIAGNODE-1 and DIAGNODE-2, as well as on the large-scale meta-analysis encompassing data from more than 600 individuals from previous Phase II and Phase III trials using Diamyd®. The trial design provides a high probability to reach its co-primary endpoints of preservation of endogenous insulin producing capacity measured as stimulated C-peptide and improved blood glucose control as determined by HbA1c.

DIAGNODE-3 is supported in part by funding from JDRF, the leading global type 1 diabetes research and advocacy organization... Diamyd Medical's Press Release -

Medicare Coverage Significantly Expanded for the Eversense E3 CGM System

The decision is further recognition of Eversense as an important option for people with diabetes.

12 February 2024, Parsippany, United States - Ascensia Diabetes Care, a global diabetes care company, and Senseonics Holdings, Inc. (NYSE American: SENS), a medical technology company focused on the development and manufacturing of long-term, implantable continuous glucose monitoring (CGM) systems for people with diabetes, announced that Medicare has significantly expanded access to the Eversense E3 CGM System, the longest lasting CGM available, with the implementation of Local Coverage Determinations providing access to implantable CGM for basal only patients, by the first three Medicare Administrative Contractors (MACs).

Medicare coverage has been expanded for implantable CGMs to include all people with diabetes using insulin, removing the previous requirement for multiple insulin administrations per day. The new policy has also been updated to cover non-insulin-users who have a history of problematic hypoglycemia. Noridian, Palmetto and National Government Services (NGS) are the first three MACs to publish final local coverage determinations (LCD). The earliest MAC expansion becomes effective on February 25, 2024 and the companies expect the remaining MACs to finalize their expansion in the near future.

“We welcome this policy change and look forward to bringing this differentiated CGM option to millions of more Americans through Medicare,” said Rudy Thoms, VP, CGM Commercial US of Ascensia Diabetes Care, a subsidiary of PHC Holdings Corporation (TSE 6523). “Eversense E3 is a truly unique technology and optionality is key in diabetes care, where what works for one person does not always work for all. In particular, our Medicare users love that this twice-yearly CGM offers them unparalleled reliability and flexibility, without the burden of regular self-insertions and the constant reordering of supplies. It is important that people with diabetes have the same access to the benefits of a fully implantable, long-term CGM, as they do to traditional CGMs [that have a much shorter lifespan], and so we are thrilled to see this expansion.”... Ascensia Diabetes Care's Press Release - Senseonics' Press Release -

RION Announces Initiation of Phase 2A Clinical Study for Purified Exosome Product™ (PEP™) in Diabetic Foot Ulcers

• RION's Phase 2A clinical trial focuses on evaluating the safety and efficacy of Platelet Exosome Product™ (PEP™) combined with TISSEEL fibrin sealant for treating Diabetic Foot Ulcers (DFU).
• Diabetic Foot Ulcers, affecting 18.6 million people worldwide each year, significantly impact quality of life and impose substantial economic burdens on healthcare systems.
• The trial is a key part of RION's broader efforts in regenerative medicine, aiming to address unmet needs in the treatment of chronic conditions such as DFU.

January 30, 2024 - ROCHESTER, Minn.--RION, a clinical-stage regenerative medicine company, at the forefront of the exosome therapeutic revolution, has officially commenced a Phase 2A study aimed at assessing the efficacy and safety of its exclusive exosome regenerative therapeutic, known as Purified Exosome Product™ (PEP™), for the management of Diabetic Foot Ulcers (DFU).

Diabetic Foot Ulcers affect approximately 18.6 million people worldwide each year1 and are associated with increasing rates of amputation and death​​. The economic burden of DFUs is substantial, imposing $13 billion in cost on the US public and private healthcare systems.2 The trial is a key part of RION's broader efforts in regenerative medicine, aiming to address unmet needs in the treatment of chronic conditions such as DFU.

Building on the success of the Phase 1B study conducted at Mayo Clinic, RION's Phase 2A trial represents a significant step forward in the development of a regenerative biologic for Diabetic Foot Ulcers. This prospective, randomized, multi-center study will involve 40 patients across the United States. Patients will be divided into two cohorts: one receiving standard care and the other treated with PEP™ exosomes, enabling a thorough comparison of outcomes.

A positive outcome in the Phase 2A trial has the potential to pave the way for a pivotal study followed by the submission of a Biologics License Application (BLA). PEP™ addresses a significant unmet medical need in the realm of diabetic wound care... RION's Press Release - 

Modular Medical Announces 510(k) Submission of MODD1 Insulin Pump

SAN DIEGO, CA / January 19, 2024 / Modular Medical, Inc. (NASDAQ:MODD) ("Modular Medical" or the "Company"), a development-stage, insulin delivery technology company seeking to launch the next generation of user-friendly and affordable insulin pump technology, announced the premarket submission of its MODD1 next-generation insulin pump to the FDA for 510(k) clearance.

"This is an exciting milestone for the Company, as we seek to change the diabetes market. Almost 30 years after the introduction of the first insulin pump, more than three quarters of those who could benefit from wearing a pump do not wear one. It is our belief that our simplified design will encourage many "almost-pumpers" to adopt technology to aid in their diabetes management, without the complexity and expense required by many of the current solutions," said Paul DiPerna, Chairman and CTO of Modular Medical.

Jeb Besser, CEO of Modular Medical, stated "Getting a person who requires daily insulin to adopt a pump instead of multiple daily injections can reduce healthcare costs and improve long-term patient outcomes. Pump adoption has been impeded by the ‘three-Cs:' they are too complex, cumbersome and costly. The MODD1 was designed to be simple and affordable with an attractive form factor. We believe our two-part patch pump design, easy to learn interface and scalable manufacturing will all contribute to a differentiated and lower cost marketing approach."... Modular Medical's Press Release -

PolTREG receives US Patent Office Notice of Allowance for Treg cell therapy to treat Type-1 Diabetes

Gdańsk, Poland – 16 January 2024 – PolTREG S.A. (Warsaw Stock Exchange: PTG), a clinical-stage biotechnology company in Europe developing cell therapies for use in a wide range of autoimmune diseases, announced it received a Notice of Allowance from the United States Patent and Trademark Office (USPTO), covering the manufacturing of T-regulatory cells (T-reg) to treat Type-1 Diabetes (T1D), and ways the therapy is administered. The US allowance constitutes an important addition to the intellectual property portfolio covering PolTREG’s autoimmune therapies.

“This USPTO decision complements our extensive intellectual property portfolio in the US and EU, paving the way for rapid, unimpeded commercialization of PolTREG’s cell therapies,” said PolTREG CEO Prof Piotr Trzonkowski. “Together with our 17 years of experience with patients at our own facilities in Poland, our dominant intellectual property portfolio demonstrates that we are leading pioneers in the field of T-reg therapeutics for autoimmune disorders. Indeed, we are the first ever to have administered Treg cell therapies to patients and the first company to begin receiving revenues from sales of our lead product; so far, 27 patients have been successfully treated commercially under the Hospital Exemption program in Poland.”

The US patent application covers the manufacturing of Treg cells, the formula of the cellular medicinal product containing Treg cells, and the ways the therapy is administered in T1D patients... PolTREG's Press Release - 

OcuTerra Therapeutics Announces Last Patient Completes Final Visit in Nesvategrast (OTT166) Eye Drop Phase 2 DR:EAM Clinical Trial in Diabetic Retinopathy

 - Topline results from study expected in Q1 2024

- Nesvategrast is a novel small molecule, potential first-in-class selective RGD integrin inhibitor specifically engineered for ocular delivery

- Addresses critical need for non-invasive, more accessible therapy for millions of patients worldwide suffering from diabetic retinopathy, a progressive, vision-threatening eye disease

January 03, 2024 - BOSTON-- OcuTerra Therapeutics, Inc. (“OcuTerra”), a clinical stage ophthalmology company developing innovative drugs to treat ophthalmic diseases for which the current standard of care of “watch-and-wait” does not prevent or control the progression of disease, announced the completion of the last patient’s final visit in the Phase 2 DR:EAM (Diabetic Retinopathy: Early Active Management) clinical trial of nesvategrast (OTT166). Nesvategrast, OcuTerra’s novel, selective RGD integrin inhibitor delivered via eye drop, is being developed as a possible treatment for the millions of patients with diabetic retinopathy who currently have no active, non-invasive therapies approved for this potentially devastating disease.

“The final patient visit in OcuTerra’s Phase 2 DR:EAM clinical trial brings us one step closer to providing an acceptable, non-invasive, active treatment to patients with diabetic retinopathy who are not actively managed due to the invasive nature of approved therapies, namely injections and/or laser,” said David Tanzer, M.D., board-certified ophthalmologist and Chief Medical Officer of OcuTerra Therapeutics. “We are incredibly pleased that this study has been a smooth process from start to finish. I would like to thank all of the clinical trial site staff, investigators, and study participants for their support of our work, and I am proud of the amazing clinical team that has achieved this latest study milestone.”

Topline data for the DR:EAM study are expected in the first quarter of 2024. These data will show the percentage of patients that have a ≥2-step improvement in the Diabetic Retinopathy Severity Scale (DRSS) when treated with nesvategrast vs. placebo. The 24-week study enrolled 225 adult patients with moderately severe to severe non-proliferative diabetic retinopathy (NPDR) or mild proliferative diabetic retinopathy (PDR) with minimal vision loss.

“The forthcoming data from the DR:EAM trial represents a significant step forward in our mission. We look forward to reviewing the data from the DR:EAM clinical trial and sharing our insights on how nesvategrast could benefit millions of patients living with DR,” said Kerrie Brady, President and CEO of OcuTerra Therapeutics. “Nesvategrast epitomizes our commitment to patient-centric innovation. This achievement marks a significant advancement in the development of what could be the first non-invasive therapy for diabetic retinopathy, a condition that currently lacks proactive, patient-friendly treatment options. We are excited to begin planning the next phase of development for nesvategrast.”... OcuTerra Therapeutics' Press Release -

Enable Biosciences Receives $3M Phase IIB SBIR Award from NIDDK for Advanced T1D Testing Technology

Enable Biosciences Inc., a leader in diagnostic technologies, is elated to announce its receipt of a Phase IIB Small Business Innovation Research (SBIR) award from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The $3 million grant is a significant boost in the company's development of its innovative dried blood spot test for Type 1 Diabetes (T1D) autoantibodies, utilizing the patented Antibody Detection by Agglutination-PCR (ADAP) technology. A key objective of this funding is to pursue FDA clearance for the T1D test, a critical step towards commercialization.

Type 1 diabetes is a life-altering autoimmune disease affecting millions, characterized by the destruction of insulin-producing pancreatic cells, necessitating lifelong insulin therapy. Early detection of T1D is essential for effective management and reducing the risk of severe complications. The importance of early detection is highlighted by recent therapeutic developments that suggest the possibility of delaying the onset of type 1 diabetes through early intervention.

Dr. Jason Tsai, PhD, Chief Technical Officer at Enable Biosciences, shared his enthusiasm: “This Phase IIB SBIR award from NIDDK is a testament to our dedication to transforming T1D testing. With this funding, we are a step closer to achieving FDA clearance for our ADAP technology, which is crucial in the context of new therapies capable of delaying T1D onset.”

The project, supported by the NIDDK award, aims to achieve three primary goals:

1. Developing a Comprehensive Quality System: Critical to ensuring the high-quality production of test components, this system will comply with FDA guidelines, ensuring safety and effectiveness.

2. Laboratory Analytical Validation: This phase will evaluate the assay for consistency, sensitivity, and resistance to common interferences, setting a new standard in T1D testing accuracy.

3. Clinical Validation: Collaborating with top clinical specimen collection sites globally, Enable Biosciences seeks to validate the effectiveness of its testing method, benchmarking it against current diagnostics.

The NIDDK's support is pivotal for Enable Biosciences in its pursuit of FDA clearance for its innovative T1D test. This development comes at a crucial time, aligning with the advent of new therapies that show promise in delaying the onset of type 1 diabetes when administered early.

Enable Biosciences is dedicated to utilizing this grant to make significant strides in T1D diagnostics, potentially changing the lives of millions affected by this disease. The company's commitment to pioneering diagnostic solutions aligns with the evolving landscape of diabetes management, promising a future where early detection and intervention lead to improved health outcomes for individuals at risk of or living with type 1 diabetes.