Innovative drugs for transdermal treatment of acute gout appear at the annual EULAR conference of the European Association of Rheumatology
Preface
At the beginning of this month, the author received a push reminder from the EULAR video website of the European Association of rheumatology. This annual meeting will be held in Copenhagen, Denmark, on the Internet platform and face-to-face from June 1 to 4, 2022. The annual meeting of major disciplines is an important occasion for the disclosure of research results and a wind vane for the development of frontier disciplines. The author visited the official website of the annual meeting to view the meeting agenda, exchange forms, and download, retrieve, and study the summary compilation of the Yearbook of this annual meeting.
(source: screenshot of video website)
(source: summary of 2022eular annual meeting)
Since the launch of the EULAR European rheumatology conference in 2000, the EULAR European rheumatology conference has become a major platform for the exchange of scientific and clinical information in Europe. The EULAR conference is usually held in June in one of the major cities in Europe. Over the years, the EULAR conference has won a reputation as the most innovative platform for medical practitioners, especially in obtaining information about new clinical research. The conference attracted more than 18000 delegates from more than 130 countries.
Dyv702 for acute gout clinical phase IIa trial results publication
Dyve Biosciences, Inc. ("dyve") is a biotechnology company focusing on the clinical drug research and development stage. It applies its patented transdermal drug delivery technology to a wide range of clinical treatment pipelines. On June 2, the conference was held. Dr. puja Paul Khanna, the chief researcher of dyve (Doctor of medicine, master of public health, Institute of Rheumatology, University of Michigan), introduced the specific target results of clinical IIA trial, Dyv702 is dyve's patented sodium bicarbonate transdermal cream formula, which aims to quickly and directly relieve joint pain affected by gout. The aim of this study was to evaluate the ability of dyv702 to reduce the severity of acute pain and pain related endpoints in 98 gout patients at 20 clinical centers in the United States during a 7-day treatment period. On site presentation of Dr. Khanna's meeting: "There is still a lack of effective and approved treatments to alleviate the severe and attenuated pain associated with acute gout attacks. In the past two decades, the number of hospitalizations for acute gout attacks in the United States has doubled. Currently, clinical treatment drugs such as steroids, colchicines, non steroidal anti-inflammatory drugs and IL-1 inhibitors are outdated and non selective, which will lead to significant side effects and frequent drug interactions Health. Using most current therapies, about half of the patients will improve within 48 to 72 hours, but the early onset pain within the first 24 hours has never been completely relieved, and it is still the largest unmet treatment demand. These data on dyv702 show that during the critical first 24 hours, the pain intensity is significantly reduced and clinically significant, and the body function is significantly improved... "
(source: screenshot of dyv-702 project lecture notes)
Dr Khanna continued: "Among those who met the protocol, we found that the median time for pain relief in the dyv-702 group was 24 hours, compared with 72 hours in the control group, and the 24-hour effective rate in the dyv-702 group was 58%, which was significantly better than 28% in the control group. These patients welcome or prefer an on-demand, rapid, locally applied treatment method that can provide clinically meaningful pain relief within 24 hours before the onset of gout. After seeing these encouraging phase 2 results, we We look forward to further exploring such candidate drugs in later clinical studies. "
Dyve Biosciences, Inc. drug development pipeline
(source: dyve's official website)
The progressive value of dyve patented transdermal infusion technology
The current transdermal technology usually uses harsh solvents or complex devices to penetrate the skin barrier, resulting in skin irritation and damage caused by long-term use. Therefore, dyve has also developed a mild microemulsion, which can make the lipid matrix flow instantly and reversibly, and conduct non-destructive administration through the skin and blood in a manner that does not damage the pharmacokinetics through the local application of regulatory effect.
Pharmacokinetic advantages
Safe transport of molecules with chemical properties far beyond the limits of other transdermal technologies
Unprecedented bioavailability compared with other transdermal drug delivery
Achieve systemic administration beyond the oral baseline while avoiding first pass metabolic and gastrointestinal related adverse events
Leming point of view
Alkalized urine is one of the three axes (pain relief, acid reduction and alkalized urine) for the treatment of gout. Compared with the normal population, the urine of patients with gout is generally acidic. Therefore, alkalization of urine is a necessary means whether in the acute attack stage or chronic acid reduction stage of gout. Whether to alkalize urine in patients with hyperuricemia and gout has been a controversial issue. In 2019, the American rheumatism society clearly proposed "against alkalized urine" in the gout clinical practice guide. Why is the latest American gout guideline "against alkalized urine"? Because long-term use of sodium bicarbonate can cause water and sodium retention, which can not only cause and aggravate hypertension, but also induce heart failure. In the United States, allopurinol is the first-line drug for the treatment of gout. Due to the drug habit and the low positive rate of genes related to allopurinol hypersensitivity in Caucasians, benzbromarone has never been listed in the United States. However, in China, especially for the Chinese Han people, because the positive rate of hla-b5801 is relatively high, the use of allopurinol may lead to serious allergic drug eruption and even death. Therefore, at present, benzbromarone is the most prescribed gout acid lowering drug in China, Taiwan and other places. At the beginning of treatment with benzbromarone, a large amount of uric acid was excreted with urine. It is necessary to prevent uric acid crystallization due to excessive uric acid by alkalizing urine. However, when allopurinol and fibrin are the main drugs in the United States, it is not necessary to alkalize urine at the same time. Sodium bicarbonate is the most commonly used alkaline urine drug in clinic because of its low price. Sodium bicarbonate should be taken at least 1~2 hours apart from other drugs, and carbon dioxide will be produced in the stomach after taking it, which can increase gastric pressure, cause belching and secondary increased gastric acid secretion, stomach pain, gastric bleeding, etc. As the most common biochemical index of human body, it is difficult to achieve rapid and effective change of local environmental pH value of human body through traditional oral drug delivery. The sodium bicarbonate transdermal cream under development by dyve is eye-catching both from the basis of project approval and the newly disclosed phase IIa clinical results. Other sodium bicarbonate topical preparations are also under active research and development, such as sodium bicarbonate vaginal gel for the treatment of vaginal candidiasis. Scientists are making great efforts to design, transform and screen a new generation of API. In recent years, API R & D and preparation costs have multiplied exponentially. The contradiction between the recession of human economic development and the rising demand for health care of the aging population has become increasingly prominent. However, drug delivery methods have not made a breakthrough. The most common is injection and medication. The new generation of transdermal drug delivery methods can achieve "treating headache and foot pain", To avoid invading irrelevant system areas to the greatest extent, and obtain pharmacokinetic test data equal to or even better than some oral API varieties, which is worthy of exploration and project approval by powerful enterprises in the academic and industrial circles.
reference material:
https://www.youtube.com/user/eularorg/videos
https://congress.eular.org/myUploadData/files/eular_2022_abstracts_final_lowres.pdf
https://dyvebio.com/wp-content/uploads/TARGETS_EULAR-2022-v2.2-Final-for-Upload.pdf
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