BUSINESS INSIGHTS, PHARMACY MARKET
Globenewswire | March 28, 2023
EyePoint Pharmaceuticals, Inc. a company committed to developing and commercializing therapeutics to improve the lives of patients with serious eye disorders, today announced it has completed enrollment in the Phase 2 "Durasert® and Vorolanib in Ophthalmology 2" (DAVIO 2) clinical trial evaluating EYP-1901 as a potential six-month maintenance treatment for wet age-related macular degeneration (wet AMD). The trial exceeded its original target of 144 patients, enrolling a total of 160 patients. All patients were previously treated with a standard-of-care anti-VEGF therapy and were randomly assigned to one of two doses of EYP-1901 or to an aflibercept on-label control.
“We are thrilled to announce the completion of enrollment in our oversubscribed Phase 2 DAVIO 2 trial evaluating EYP-1901 in wet AMD, marking an important milestone as we continue to advance our pipeline of innovative sustained delivery treatments for serious eye disorders,” said Nancy Lurker, Chief Executive Officer of EyePoint Pharmaceuticals. “Patients with wet AMD face an immense treatment burden, requiring monthly or bi-monthly eye injections for the rest of their lives in order to prevent severe vision loss. The high level of patient and physician interest we saw in the trial enrollment further demonstrates the great unmet need in this population for a maintenance treatment option that is safe, effective, long-lasting and convenient.”
“We look forward to reporting topline data in the fourth quarter of this year. With these data and the promising results from our Phase 1 DAVIO trial, EYP-1901 will have the largest and most robust dataset of any tyrosine kinase inhibitor (TKI) product in development for wet AMD. These data will inform the design of our pivotal Phase 3 clinical trials and provide optionality as we seek to bring this promising product to patients. I would like to thank our dedicated team of employees and clinical partners, as well as the patients who enrolled in the Phase 1 and Phase 2 EYP-1901 trials and their caregivers for advancing the development of EYP-1901,” continued Ms. Lurker.
DAVIO 2 is a randomized, controlled Phase 2 clinical trial of EYP-1901 in patients with wet AMD. Originally designed to enroll 144 patients, the trial enrolled 160 patients in total due to strong investigator and patient interest. All enrolled patients were previously treated with a standard-of-care anti-VEGF therapy and were randomly assigned to one of two doses of EYP-1901 (approximately 2 mg or 3 mg) or an aflibercept control. EYP-1901 is delivered with a single intravitreal injection in the physician's office, similar to current FDA approved anti-VEGF treatments. The primary efficacy endpoint of the DAVIO 2 trial is change in best corrected visual acuity (BCVA) compared to the aflibercept control, six-months after the EYP-1901 injection. Secondary efficacy endpoints include change in central subfield thickness (CST) as measured by optical coherence tomography (OCT), number of eyes that remain free of supplemental anti-VEGF injections, number of aflibercept injections in each group, and safety.
“Our ‘Treat to Maintain’ therapeutic approach for EYP-1901 has the potential to transform the wet AMD treatment paradigm, and we are incredibly pleased to complete enrollment with more patients than planned in the DAVIO 2 clinical trial due to high demand to participate from investigators and patients,” said Jay Duker, M.D., President and Chief Operating Officer of EyePoint Pharmaceuticals. “The compelling Phase 1 DAVIO results demonstrate EYP-1901’s potential to transition a majority of patients to an every-six-month treatment for wet AMD, representing a ‘treat to maintain’ therapeutic approach that uses EYP-1901 as a baseline therapy following the use of large molecule anti-VEGFs with the goal of significantly extending the patient’s treatment interval. Based on the extensive prior clinical data evaluating Durasert in four FDA-approved indications, we are confident in EYP-1901’s ability to consistently deliver the active drug, vorolanib, with zero-order drug release kinetics using our bioerodible sustained delivery technology, Durasert® E. In addition, vorolanib brings a new mechanism of action for wet AMD patients and may have additional neuroprotective benefits. We are confident in EYP-1901’s potential to enhance treatment compliance, improve clinical experience and, ultimately, result in better patient outcomes.”
EYP-1901 is being developed as an investigational sustained delivery treatment combining a bioerodible formulation of EyePoint's proprietary Durasert® delivery technology (Durasert® E) with vorolanib, a tyrosine kinase inhibitor. Positive safety and efficacy data from the DAVIO Phase 1 clinical trial of EYP-1901 showed a positive safety profile with stable visual acuity and OCT. Further, 53% and 35% of eyes did not require any supplemental anti-VEGF injections up to six and twelve months, respectively, following a single dose of EYP-1901. Phase 2 studies are underway for wet AMD and non-proliferative diabetic retinopathy and are planned in diabetic macular edema. Vorolanib is licensed to EyePoint exclusively by Equinox Sciences for the localized treatment of all ophthalmic diseases.
About EyePoint Pharmaceuticals
EyePoint Pharmaceuticals is a company committed to developing and commercializing therapeutics to help improve the lives of patients with serious eye disorders. The Company's pipeline leverages its proprietary Durasert® technology for sustained intraocular drug delivery including EYP-1901, an investigational sustained delivery intravitreal anti-VEGF treatment currently in Phase 2 clinical trials. The proven Durasert drug delivery platform has been safely administered to thousands of patients' eyes across four U.S. FDA approved products, including YUTIQ® for the treatment of posterior segment uveitis, which is currently marketed by the Company. EyePoint Pharmaceuticals is headquartered in Watertown, Massachusetts.
RESEARCH, BUSINESS INSIGHTS
Medidata Solutions | March 13, 2023
Medidata, a leading provider of innovative software solutions for clinical trials that streamline the clinical trial process, reduce time and cost, and accelerate the development of new treatments, recently announced that Allucent, a contract research organization (CRO) that brings innovation to biopharma firms, is expanding the global use of Medidata's Clinical Cloud to enhance its clinical trial operations offering.
This agreement extends Allucent's current usage of Medidata's technology, which includes eCOA, Rave EDC, RTSM, and Rave Imaging, supporting crucial development areas such as rare and orphan indications, oncology and cell and gene therapies. As part of the deal, Allucent's team achieved 100% Rave EDC certification, reinforcing their dedication to quality and providing clients with industry-leading technology.
Allucent is a sponsor of Medidata NEXT London and will give a presentation on data analytics for early-phase oncology trials. The presentation will cover how working with Medidata has helped them apply visualization techniques and strategies to extract the total value of information for all stakeholders.
Medidata is a Dassault Systèmes company poised to drive the digital transformation of life sciences in the age of personalized medicine with its 3DEXPERIENCE platform. This platform is the first end-to-end scientific and business solution, from research to commercialization.
Medidata's head of Global Sales, Janet Butler, commented, "Allucent is leveraging the power of the Medidata Clinical Cloud to solidify their position at the forefront of clinical technology." She further emphasized, "Their work with novel therapies requires agile, patient-centric solutions. We are proud to build on our eight-year collaboration to advance the digital transformation of life sciences and deliver clinical innovations to help reach their goals."
(Source – Business Wire)
About Medidata Solutions
Medidata Solutions is a New York-based global provider of cloud-based software solutions for clinical trials. Its platform, the Medidata Clinical Cloud, enables pharmaceutical, biotechnology, medical device companies, and academic research organizations to manage all aspects of clinical trials, including study design, data capture, management, and analysis. Medidata's platform can capture real-time data from multiple sources, including electronic health records and wearable devices, to monitor patients closely, identify potential safety issues earlier, and make informed decisions about trial design and treatment protocols. The platform also features advanced analytics tools like machine learning and artificial intelligence algorithms to help researchers analyze and interpret their data. In 2019, Dassault Systèmes, a global leader in 3D design software and simulation solutions, acquired Medidata, further enhancing its platform.
BUSINESS INSIGHTS, PHARMACY MARKET
Prnewswire | April 25, 2023
On April 20, Patsnap, the world's leading SaaS provider for intelligence, announced the launch of its latest version of the intelligence platform, Synapse, available to visitors. This version includes advanced search functions for drugs and pharmaceutical organizations, now publicly accessible for the first time. Users can explore these features without prior registration, making searching easier and more accessible than ever before.
Synapse is an innovative Life Sciences Platform that uses AI technology to connect Drug Discovery information with Drug Development insights. This allows professionals in the pharmaceutical industry to make better-informed decisions throughout the entire innovation cycle. With a vast database of millions of free data points from over 150 jurisdictions, Synapse provides access to over 72,000 new drugs, 800,000 clinical trials, 6 million pharmaceutical patents, 62 million literature sources, 360,000 pharmaceutical organizations, and more. This wealth of information is available to users to aid them in their research and decision-making processes.
One of the key benefits of Synapse is its extensive database of drugs, particularly those in their preclinical or early developmental stages, which helps to mitigate potential risks for professionals in the pharmaceutical industry. "We want to ensure that we are only developing drugs that are efficiently managed, reducing the risks of failure at the later stages of development," said one of our key clients, the head of R&D. By having access to this valuable information, professionals can make more informed decisions and focus their efforts on drugs with a higher potential for success, ultimately saving time and resources.
Available on Synapse's website as a free solution, key features include
Drug Advanced Search:Quickly and accurately identify drugs based on specific criteria of interest. The search function covers global drug candidates and marketed drugs, and mines preclinical R&D intelligence in patents and literature to identify early competitive risks.
Clinical Progress:Screen clinical trials by drugs, institutions, targets (multi-target), indications, clinical trial phase, and other conditions. Synapse collates data from 18 registries, including CT.gov and WHO, giving users a global view of the clinical landscape.
Playbook: Access multiple data sets with a single search, including Due Diligence and Find Organizations. This feature provides comprehensive and visualized insights into the organization's R&D preferences, drug pipeline, investments, financing, and more.
Literature Search:With over 62 million literature records in the life sciences field, users can easily screen literature by drugs, targets, indications, authors, and other criteria. This feature allows for efficient and targeted research, saving time and increasing productivity.
Founded in 2007, Patsnap is the company behind the world's leading AI-powered innovation intelligence platform. Patsnap provides global businesses with a connected, easy-to-use platform that helps them make better decisions in the innovation process. Customers are innovators across multiple industry sectors, including agriculture and chemicals, consumer goods, food and beverage, life sciences, automotive, oil and gas, professional services, aviation and aerospace, and education.