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.”
About EYP-1901
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.
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BUSINESS INSIGHTS, PHARMACY MARKET
Cellworks Group | January 13, 2023
Cellworks Group Inc., a pioneer in personalized therapy biosimulation, announced the introduction of its precision drug development business units.
These units will use predictive biosimulation to shorten drug development time-to-market and revive previously researched but disapproved pharmaceutical assets.
The two new business units will use Cellworks' computational biology model (CBM) and biosimulation platform to predict responses to pharmaceutical interventions in silico, streamlining the clinical trial by identifying suitable patients more quickly, thereby reducing the time and cost of developing successful pharmaceutical agents.
Cellworks precision drug development: Pre-clinical stage
Companion molecule development: The Cellworks platform can augment a drug's usability by finding companion molecules that improve performance when combined with the investigational agent.
Biomarker development: Cellworks utilizes cell lines and historical patient data to uncover novel biomarkers for investigational agents. This may increase drug success rates by proactively identifying individuals who will respond to an agent.
Indication expansion: By utilizing the Cellworks patient database of 100,000+ omics patient profiles and 1,800 oncology cell lines to examine the agent's effectiveness in different indications, the Cellworks platform can identify additional indications where an experimental treatment may be successful.
Cellworks precision drug development: Clinical stage
Drug revival and repurposing: The platform seeks to anticipate whether certain drugs cause a response, which may be used to identify whether shelved assets can be resurrected via suitable patient selection or the discovery of non-obvious reasons.
Clinical trial biosimulation: Through biosimulation clinical trials, the Cellworks platform may anticipate humans' clinical response to pharmaceutical agents in weeks, yielding critical insight years ahead of a traditional clinical practice.
Cellworks Platform and Computational Biology Model (CBM)
The Cellworks platform biosimulates the impact of specific pharmacological molecules on a given patient or class of patients using the patient's genetic profile. To generate a customized or cohort-specific disease model, multi-omic data from a cohort or patient is fed into the Cellworks computational biology model (CBM).
About Cellworks Group
Cellworks is one of the leaders in precision medicine. The organization assists physicians and payers in navigating the most efficacious, cost-effective therapies for patients. Its primary therapeutic areas are oncology, immunology, dermatology, and infectious diseases. Its one-of-a-kind biosimulation platform is a unified representation of biological information gathered from disparate databases and used to find cures. The company has the world's strongest trans-disciplinary team of molecular biologists, cellular pathway modelers, and internet software technologists working towards a common goal, i.e., taking on significant diseases to improve patients' lives.
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BUSINESS INSIGHTS, PHARMACY MARKET
Shields Health Solutions | March 17, 2023
Shields Health Solutions (Shields), the premier specialty pharmacy accelerator in the country, announced that it has partnered with Nemours Children’s Health, Delaware, to collaborate in developing a specialty pharmacy program that will provide patients with complex, chronic conditions access to specialized pharmacy services designed to lower costs, expand treatment options, enhance medication management, and improve overall health.
Shields will provide Nemours Children’s Health new support services through its partnership to meet the unique needs of patients with complex chronic conditions. Now, specialty pharmacy liaisons will work with patients on-site in clinics, offices, and pharmacies, among other locations, guiding patients who fill their prescriptions with Nemours Children’s. These liaisons work with teams of experts to assist patients and families with a multitude of tasks, including health insurance prior authorizations or securing financial assistance to help overcome one of the significant barriers to care.
These expanded patient support services, combined with access to recently approved and newly available drugs, will give Nemours’ patients greater availability for onsite treatment options. Shields currently partners with nearly 80 health systems around the country and has helped their patients reduce co-pays, promptly receive medication delivery, often within two days, and improved medication adherence greater than 90 percent on average.
Nemours Children’s Health is one of the largest multistate pediatric health systems in the country and provides award-winning care to more than 38,000 specialty patients. The complete health system includes two free-standing children's hospitals and a network of more than 70 primary, specialty and urgent care practices. US News & World Report ranked Nemours Children’s Hospital, Delaware among the 10 best children’s hospitals in the Mid-Atlantic region and recognized Nemours Children’s Hospital, Florida for excellence in orthopedics and endocrinology.
“Nemours’ commitment to outstanding care for children with chronic diseases aligns with Shields core mission,” said Stephen Davis, Senior Director of Health System Strategy. “Specialty pharmacy services provide challenges for all patient populations, but pediatric patients have unique needs that require tremendous support. We are proud to provide that support for patients at Nemours Children’s Health and help them achieve the best possible health outcomes.”
“As Nemours Children’s Health works toward creating the healthiest generations of children, it is imperative to address social determinants of health including access to medications that are affordable, said,” said Robert J. Mullen, BS, PharmD, RPh, Vice President, Patient Operations, Delaware Valley, at Nemours Children’s Health, Delaware. “Specialty pharmacy services can cause many challenges for the complex patients that Nemours Children’s cares for on a daily basis. We are proud to be partnering with Shields Health Solutions to help ease the burden for families acquiring prescription medication for their children and in turn achieve better health outcomes.”
About Shields Health Solutions
Shields Health Solutions (Shields) is the premier specialty pharmacy accelerator in the country. The Shields Performance Platform, an integrated set of solutions, services and technology, is intentionally designed to elevate payer and drug access for specialty pharmacies, elevate health outcomes for complex patients, and elevate growth throughout the entire health system. As the foremost experts in the health system specialty pharmacy industry, Shields has a proven track record of success including access to over 80 percent of all limited distribution drugs (LDDs) and most (health insurance) payers in the nation; and a clinical model proven to lower total cost of care by 13%. In partnership with more than 70 health systems across the country through national-scale collaboration, Shields has a vested interest in delivering measurable clinical and financial results for health systems.
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