Diabetic Neuropathies

AUCKLAND, New Zealand, May 1, 2025 /PRNewswire/ -- Soft tissue regeneration company, Aroa Biosurgery, is pleased to announce a milestone in clinical evidence. There are now over 100 peer-reviewed studies describing the efficacy of the company's proprietary AROA ECM technology. Continue Reading AROA's most recent publication was a large retrospective analysis of real-world evidence (RWE) from wound care centers in the US, assessing the efficacy of the company's Endoform NaturalTM product in treating venous leg ulcers (VLUs), in comparison to a leading reconstituted collagen dressing. VLU's are open sores that are hard-to-heal because of impaired blood flow and can be very debilitating and painful. These types of wounds are difficult for clinicians to treat successfully. For example, only ~40% of VLUs can be healed after 3 months of treatment and there is a relatively high chance that these wounds will recur[1]. The peer-reviewed study, entitled "Clinical Efficacy of Ovine Forestomach Matrix and Collagen/Oxidized Regenerated Cellulose for the Treatment of Venous Leg Ulcers: A Retrospective Comparative Real-World Evidence Study" was published in the open access journal 'International Wound Journal in April 2025. The study compared 470 VLU's that had been treated with Endoform Natural to 360 VLU's that had been treated with a reconstituted collagen product. The study used existing data from 223 wound care centers with minimal inclusion or exclusion criteria so that 'real-world' use of both products could be compared. "There is a growing awareness of RWE studies to validate clinical performance" says Chief Scientific Officer, Dr. Barnaby May. "These types of studies enable much larger patient numbers to be compared versus traditional randomized controlled trials. Given that RWE studies use data from 'real-world' use of a treatment, the results can be more meaningful, especially in wound care where there is a high degree of variability in how wounds are cared for and patient factors." The study found that VLUs treated with Endoform Natural healed up to ~ 8 weeks faster versus the comparator group, and the chances of the wound healing were significantly improved when Endoform Natural was used as part of treatment. The striking difference in the healing outcomes demonstrate the potential for considerable cost reductions and improvements in patient quality of life, due to the significant improvements seen when VLUs were treated using Endoform Natural. Dr. Gregory Bohn MD was part of the research team. "I was first introduced to Endoform in 2012 and started using the product to treat my own patients with VLUs. This new data validates what I have seen in my own practice managing VLUs with Endoform." This is the second large retrospective RWE comparing Endoform Natural to a leading reconstituted collagen dressing. A previous study included the analysis of over 2,200 diabetic foot ulcers (DFUs) and also demonstrated significantly faster healing of DFUs using Endoform Natural[2]. The study is available online here. SOURCE Aroa Biosurgery WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

On a call with members of the media Tuesday morning, AstraZeneca CEO Pascal Soriot focused heavily on the need for greater R&D innovation outside the U.S. \n AstraZeneca has axed three MedImmune legacy monoclonal antibody drugs from its neuroscience pipeline in a first-quarter clear-out.The Anglo-Swedish Big Pharma announced in its first-quarter presentation (PDF) Tuesday morning that it had stopped work on a phase 1 Alzheimer’s disease drug as well as two phase 2 therapies. One of the midstage candidates was being tested against migraines and the other was for osteoarthritis pain and painful diabetic neuropathy.The Alzheimer’s drug, MEDI1814, is an amyloid beta mAb that had been developed in collaboration with Eli Lilly in a pact dating back nearly a decade.Lilly, which markets its AD therapy Kisunla and teamed up with AZ on MEDI1814 back in 2016, has taken back the drug.AZ also axed two more clinically advanced prospects. The first, MEDI0618, works as a PAR2 antagonist mAb migraine drug. The market for migraine drugs, both as treatments and prophylactic options, has exploded over the past five years, with a host of meds from Pfizer/Biohaven, Eli Lilly, Amgen, Teva and more fighting for ground. The final midstage cull was for MEDI7352, a non-opioid NGF/TNF bispecific mAb targeting osteoarthritis pain and painful diabetic neuropathy.The decision for this neuro-focused clear-out was strategic, and AZ has formally terminated each of the projects. All three came from MedImmune, its $15.2 billion acquisition in 2007 that has seen multiple experimental drug clear-outs over the years.AZ generated $13.58 billion in revenue during the first quarter, a 10% increase at constant exchange rates from the first quarter in 2024. R&D spend, meanwhile, was up a hefty 16% at constant exchange rates to $3.08 billion and represented 23% of total sales.FDA layoffs, R&D boosts and a U.S. focus On a call with members of the media Tuesday morning, AZ’s chief Pascal Soriot said that despite the Trump administration-directed layoffs at the FDA, the Big Pharma has “so far not seen any delays in the processing of our applications [or] any delays to our meetings we regularly have with FDA staff.\" A big theme for Soriot was AZ\'s U.S. investment and focus, following a common trend for Big Pharmas working in the country amid pharmaceutical tariff threats from the U.S. government.He reiterated the multibillion-dollar investment AZ announced last November in manufacturing and R&D, saying that “we have even greater U.S. investment in manufacturing and R&D planned, leveraging our two large R&D sites\" in Gaithersburg, Maryland, and Cambridge, Massachusetts.Details on exactly what that R&D investment would like and specific dollar values were not given. AZ’s chief financial officer Aradhana Sarin said on the call that investments “will be driven by our portfolio” and that AZ will spend money where trials and trial sites are producing positive outcomes worthy of further investment. A spokesperson for AZ confirmed there were no immediate specifics on the R&D investment front as the company plans to review what is working over time and thus what will require deeper investment. One area will, however, be cell therapy, a field Soriot spotlighted during the call and where AZ recently acquired a Belgium cell therapy specialist.AZ also currently has seven cell therapy programs in the clinic, led by a BCMA and CD19 dual-targeting CAR-T for multiple myeloma.In response to questions about U.S. drug research innovation in general, Soriot said the country is “funding innovation in pharmaceuticals for the world” but that this was not fair. He said that Europe must take greater steps to invest more.Likening Europe’s recent decision to spend more of its gross domestic product on defense, he said Europe should take the same tack with pharmaceuticals spending, upping its percentage of GDP and/or healthcare budgets to pay more for R&D innovation.“Innovation has mostly been funded by the United States,” Soriot said on the call. “Europe now has to invest more. Just like Europe has decided to allocate a greater share of GDP to defense, a greater share of GDP has to be allocated to pharmaceutical innovation.”Soriot, when asked, did not give a specific percentage on what he thought that figure of GDP should be, but he noted the percentage of healthcare budgets spent on medicines was 13% to 15% in the U.S., while it was 10% to 11% in Europe and just 7% in the U.K., which has the NICE health technology assessment body to help temper drug prices. 

AstraZeneca’s Truqap is 2-for-4 in its pivotal cancer trials. It said it was shutting down a Phase 3 Truqap study in a hard-to-treat form of prostate cancer after an interim analysis suggested its likely failure. The disclosure was made alongside AstraZeneca’s first-quarter earnings report on Tuesday, during which the UK company also made a series of updates regarding its ongoing legal issues in China. The CAPItello-280 trial was testing the AKT inhibitor on top of chemotherapy and androgen-deprivation therapy in patients with metastatic castration-resistant prostate cancer. A prespecified interim analysis determined that the Truqap approach was unlikely to meet the dual primary endpoints of radiographic progression-free survival and overall survival versus control. AstraZeneca CEO Pascal Soriot said on a media call that the company still believes Truqap’s potential sales could be in the $1 billion to $3 billion range. “We still believe Truqap has potential, but of course, having missed on this prostate study, the potential will be smaller,” he said. Hello, James Reynolds You’re an essential part of the biopharma world. Share your voice on this important question to help shape our understanding of the industry. Can you help us out? Hello, James Reynolds You’re an essential part of the biopharma world. Share your voice on this important question to help shape our understanding of the industry. Can you help us out? Soriot said the company knew that the trial in this particular setting was “more risky” than in other cancer niches. The trial was one of five in the CAPItello program, which has so far yielded two hits and two misses. The CAPItello-291 study in second-line HR+/HER2- breast cancer with certain mutations succeeded in 2022 and formed the basis for Truqap’s approval in late 2023. But a second breast cancer trial, in first-line triple negative disease, failed last summer. A further twist came last November , with a win in de novo prostate cancer. Following the shutdown of CAPItello-280, only one late-stage trial of Truqap is underway. CAPItello-292 will test the drug as first-line therapy for advanced or metastatic HR+/HER2- breast cancer, in combination with a CDK4/6 inhibitor and Faslodex. Data are due next year and will be key to the drug making good on its blockbuster promise. The company also abandoned mid-stage trials of a PAR2 antagonist called MEDI0618 in migraine and an NGFxTNF bispecific, MEDI7352, in osteoarthritis pain and diabetic neuropathy. Pain indications are notoriously difficult to treat. So is Alzheimer’s disease, and AstraZeneca also stopped work on a Phase 1-stage amyloid beta mAb dubbed MEDI1814. Elsewhere, AstraZeneca said the unpaid tax bill it is facing in China would be larger than it had previously thought — meaning the fine authorities can impose could be bigger still. In February, AstraZeneca said the alleged unpaid taxes, which are probably tied to imports of Imfinzi and Imjudo, amounted to around $900,000. It now says that according to the Shenzhen City Customs Office, there are further suspected unpaid import taxes of $1.6 million, which AstraZeneca believes is related to sales of Enhertu. Since a punitive fine of up to five times the unpaid taxes can be imposed if AstraZeneca is found liable, the pharma could be facing a total bill of up to $15 million. There was better news on the other investigation AstraZeneca is subject to in China, which concerns the suspected unlawful collection of personal data . The company said the Shenzhen Bao’an District Public Security Bureau had determined that there was no illegal gain to the company resulting from personal information infringement. And Soriot said there were no concerns so far that cuts to the US regulator would affect the approval timelines of AstraZeneca’s products, as has happened to Stealth BioTherapeutics’ rare disease drug. “So far, we haven’t seen any delay in the processing of our applications. We haven’t seen delays in the meetings we regularly would have with FDA staff to discuss our submissions,” he said on the call.