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.

Porosome Therapeutics Announces Groundbreaking Approach to Advance Diabetes Treatment

October 30, 2023 (BOSTON) – Porosome Therapeutics, Inc. (Porosome Therapeutics) has announced a new and distinctive therapy for Type 1 Diabetes (T1D) and Type 2 Diabetes (T2D) targeting the insulin secretory defects found in beta cells associated with the disease. Porosome Therapeutics’ approach addresses the cell's secretory machinery.

Porosome Therapeutics Founder and Chairman Professor Bhanu P. Jena discovered a new cellular structure called the porosome nearly three decades ago. After its discovery, the porosome was isolated and its structure and composition determined before porosomes were successfully inserted into cells to enhance secretion. This groundbreaking discovery provides a platform for diabetes treatments, as well as other secretory disorders such as cystic fibrosis, Alzheimer’s, and certain cancers. This approach is novel in that it provides the ability to target undruggable proteins, which make up almost 85% of the human proteome.

“Identifying effective approaches to find therapeutic solutions to undruggable proteins is our major focus,” said Jena. “By targeting beta cells and incorporating additional insulin-secreting porosomes, we are able to restore the cell’s ability to secrete insulin. Similarly, a major issue in treating T1D using beta cells derived from induced pluripotent stem cells (iPSC), is the inability of these beta cells to optimally secrete insulin in response to a glucose challenge. Consequently, a large number of such beta cells derived from iPSC are required for a transplant, a major issue. This can be overcome by reconstituting insulin-secreting porosomes to the iPSC derived beta cells prior to a transplant. Our solution is a promising advancement in treating diabetes.” 

Porosome Therapeutics' has two novel therapeutic approaches.  The first is the proprietary approach of “porosome-reconstitution therapy,” where insulin-secreting porosomes are introduced into the cell plasma membrane of stem cell-derived beta cells. This approach has been demonstrated in published studies to enhance glucose-stimulated insulin secretion.  The second proprietary approach is the use of a porosome-targeted small molecule capable of both insulin synthesis and secretion from beta cells. When combined with Metformin, a widely used medication for T2D, it could offer a powerful therapeutic approach to manage and treat T2D...Porosome Therapeutics' Press Release -

Bayer closes on divestiture of Diabetes Care business to Panasonic Healthcare Holdings Co., Ltd. for around EUR 1 billion

Transaction includes blood glucose monitoring systems and lancing devices for people with diabetes 

January 5, 2016 – Bayer AG closed on its previously announced agreement to sell its Diabetes Care business to Panasonic Healthcare Holdings Co., Ltd., a company which is backed by funds sponsored by leading global investment firm KKR and the Panasonic Corporation. The total consideration for the transaction is around EUR 1 billion (JPY 132 billion). The new stand-alone Diabetes Care business is named Ascensia Diabetes Care Holdings and is headquartered in Basel, Switzerland.

The sale includes the leading Contour™ portfolio of blood glucose monitoring meters and strips, as well as other products such as Breeze™2, Elite™ and Microlet™ lancing devices. Bayer’s Diabetes Care business accounted for EUR 909 million in sales in 2014... Bayer's Press Release - Panasonic Healthcare's Press Release

FDA Approves Genentech’s Lucentis® (Ranibizumab Injection) for Treatment of Diabetic Retinopathy in People with Diabetic Macular Edema

South San Francisco, Calif. -- February 6, 2015 - Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced that the U.S. Food and Drug Administration (FDA) approved Lucentis® (ranibizumab injection) for the treatment of diabetic retinopathy (DR) in people with diabetic macular edema (DME). DME impacts nearly 750,000 Americans, about 10 percent of people with DR.

The FDA granted Lucentis Breakthrough Therapy Designation and Priority Review for this indication based on results from the RISE and RIDE Phase III clinical trials.

"While there are various options for treating diabetic macular edema, before today none were approved showing improvement in retinopathy," said Sandra Horning, M.D., chief medical officer and head of Global Product Development. "With today's approval, people with diabetic macular edema now have a FDA-approved medicine that showed meaningful improvements in retinal damage from diabetes, in addition to the established improvement in vision."... Genentech's Press Release -

CSL : drug candidate in diabetes research breakthrough

27/09/2012 - CSL Limited has developed a new drug candidate that is able to prevent the development of type 2 diabetes and reverse its progression in animal models of the disease.

The drug candidate blocks signalling by a protein known as Vascular Endothelial Growth Factor B (VEGF-B) and this prevents fat from accumulating in the “wrong” places, such as in muscles and in the heart. As a result, cells within these tissues are once again able to respond to insulin and blood glucose is restored to normal levels.

This represents an entirely new approach to the treatment of type 2 diabetes and a paper outlining this breakthrough has just been published in the prestigious scientific journal Nature.

The research is a joint effort by an international team led by Professor Ulf Eriksson from the Karolinska Institute in Sweden, and involving scientists from CSL‟s research laboratories in Melbourne, The University of Melbourne and the Ludwig Institute for Cancer Research.

“The results seen in these laboratory studies are very promising for the millions of people around the world who are affected by type 2 diabetes,” said Dr Andrew Nash, Senior Vice President of Research at CSL... CSL's Press Release -

Midatech and MonoSol Rx : Positive Phase 1 Clinical Results for their Novel Transbuccal Oral Insulin Film Product

3 May 2012 – Midatech Ltd., a global leader in the design, synthesis and manufacture of nanomedicines based on its passivated gold-nanoparticle technology, and MonoSol Rx LLC, the developer of PharmFilm® drug delivery technology, announced positive bioavailability and pharmacokinetic results from a first-in-human Phase 1 clinical study of their Midaform™ Insulin PharmFilm product in 27 healthy volunteers. The companies have licensed to their joint venture company, MidaSol Therapeutics LLC, a proprietary nanoformulated transbuccal insulin film product, which delivers monomeric insulin through the use of a rapidly dissolving mucoadhesive film that is placed onto the inside of the cheek.

Insulin, stabilized on a nanoparticle and delivered transbuccally, has the potential to offer diabetic patients a viable oral alternative to injectable insulin. The Phase 1 study established Midaform Insulin PharmFilm as a safe, novel, non-injectable insulin delivery system, which closely mimicked the delivery characteristics of monomeric insulin from the pancreas. Importantly, MidaSol’s product showed a faster onset of action compared to subcutaneous insulin. Top-line results, including PK and bioavailability elements, from the study will be presented at the European Summit for Clinical Nanomedicine (CLINAM) in Basel, Switzerland by Prof.Dr. med. Fritz R. Bühler, Chief Medical Officer and member of the Board of Midatech Ltd... [PDF] Midatech's Press Release - MonoSol Rx's Press Release -

Orgenesis : Agreement to Commence Advanced Studies for Proposed Diabetes Treatment

Apr 11, 2012 - Orgenesis Inc. (OTCBB: ORGS), a development stage company with a novel therapeutic technology dedicated to convert a patient's own liver cells into functional insulin-producing cells as a treatment for diabetes, is pleased to announce entry into an agreement to commence a comprehensive research study into the efficacy of its treatment in order to more efficiently move the technology towards future human clinical trials.

Effective March 22, 2012, Orgenesis Inc. has entered into an agreement with Tel Hashomer - Medical Research, Infrastructure and Services Ltd. ("THM"). In exchange for certain fees, licensing rights and other considerations, THM is to perform a study at the facilities and using the equipment and personnel of the Chaim Sheba Medical Center of Israel under the direct supervision of Orgenesis Chief Science Officer, Prof. Sarah Ferber.

THM will conduct the study, through the services of the Medical Research Infrastructure Development and Health Services Fund established by the Sheba Medical Center pursuant to the Research Program under the direct supervision of Prof. Ferber, who will conduct and supervise the study with the assistance of the employees, researchers and/or associates of the Hospital and/or the Fund. The study itself shall be performed pursuant to the laws, regulations and guidelines as applicable in Israel with respect to clinical research on human subjects... Orgenesis' Press Release -

NGM and Daiichi Sankyo Collaborate to Discover and Develop Innovative Therapeutics for Diabetes

March 28, 2012) – Daiichi Sankyo Company, Ltd. (hereafter, Daiichi Sankyo) and NGM Biopharmaceuticals, Inc. (hereafter, NGM) announced that they have entered into a research collaboration and license agreement to discover and develop novel therapeutics that modulate beta-cell regeneration for the treatment of diabetes. The loss or decline of beta-cell function contributes to the pathogenesis of diabetes, a chronic disease that ultimately necessitates insulin therapy for the majority of sufferers. A therapeutic providing for beta-cell regeneration could potentially be disease-modifying and represent a significant advance for patients suffering from Type 1 or Type 2 diabetes.

As part of this collaboration, NGM will apply its integrated discovery technology and in vivo screening platform to identify and validate physiologically-relevant metabolic targets that modulate beta-cell growth and function. Daiichi Sankyo and NGM will jointly conduct research on selected targets with the goal of identifying and optimizing drug candidates for further development. Daiichi Sankyo will assume responsibility for preclinical studies, clinical development, manufacturing and commercialization on a worldwide basis.

Under the terms of the agreement, NGM will receive an upfront payment and committed research funding for the duration of the collaboration. In addition, NGM is eligible to receive payments upon the achievement of research, development, regulatory and commercial milestones, as well as royalties on product sales. Daiichi Sankyo will receive an exclusive worldwide license to develop and commercialize compounds resulting from the collaboration... Daiichi Sankyo's Press Release - [PDF] NGM Biopharmaceuticals' Press Release -

ADOCIA : positive phase IIa clinical results on its fast-acting human insulin, HinsBet®

28th of February 2012 - The first clinical results are confirmed on diabetic patients - The main results of this clinical trial are a rapid reduction of glycemia, an excellent local tolerance and an inter-patient and intra-patient variability, all comparable to NovoLog® (Novo Nordisk) -

ADOCIA (ISIN: FR0011184241, Ticker: ADOC), a biotechnology company specialized in the formulation of therapeutic proteins for treating diabetes and chronic wounds (diabetic foot ulcers, venous ulcers), announces positive results from a Phase IIa clinical trial evaluating the safety and efficacy of HinsBet®, its fast-acting human insulin, in type 1 diabetic patients. This program is supported by OSEO.

This phase IIa study was a single center, double-blinded, randomized, cross-over trial conducted on 20 type 1 diabetic patients under euglycemic clamp procedure. The aim of the study was to compare pharmacokinetics, pharmacodynamics and safety of HinsBet® to the fast-acting insulin analog NovoLog®, after 3 consecutive injections of each study medication to each patient.

The hypoglycemic effect of HinsBet® is as rapid as the one of NovoLog®, one of the modern prandial insulins. Furthermore, neither serious adverse event nor clinically significant change in laboratory safety parameters occurred in this study. On local tolerance, HinsBet® was as good as NovoLog®. Finally, the inter and intra patients variabilities of the two medications after 3 consecutive injections are also similar on pharmacological parameters... [PDF]ADOCIA's Press Release - PDF du communiqué de presse ADOCIA -

Medistem : Exclusive Worldwide License With Yale University for Treatment of Type 1 Diabetes Using Stem Cells

March 7, 2012 - Medistem Inc. (MEDS.PK) and Yale University have signed an exclusive worldwide licensing agreement covering the generation of pancreatic islets from stem cells such as the Endometrial Regenerative Cell (ERC). These pancreatic islets have effectively treated diabetes in animal models.

Professor Hugh Taylor of Yale University, inventor of the technology, made international headlines in September 2011 when he published his findings in the peer-reviewed journal Molecular Therapy.

“Medistem is the first company to develop clinical-grade endometrial-derived stem cells and initiate trials in humans,” said Professor Taylor. “Since Medistem’s Endometrial Regenerative Cells are manufactured inexpensively, can be used as an ‘off the shelf’ product, and to date appear safe in human subjects, I am very excited to see diabetes added to the list of diseases that can potentially be treated with Medistem’s ERCs.”... Medistem's Press Release -