BUSINESS INSIGHTS, PHARMA TECH
Lyra Therapeutics | February 08, 2023
On February 6, 2023, Lyra Therapeutics, Inc., a leading clinical-stage biotechnology firm developing novel therapies for the localized treatment of chronic rhinosinusitis (CRS), announced that enrollment in the Phase 2 BEACON clinical trial of LYR-220 in adult patients with CRS who have previously undergone sinus surgery has been completed.
LYR-220 is designed to provide continuous anti-inflammatory medicine (mometasone furoate; MF) to the sinonasal passageways for six months in order to treat CRS. Topline outcomes are expected in the fourth quarter of 2023.
The Phase 2 BEACON trial is a sham-controlled, parallel-group trial designed to assess the efficacy and safety of the LYR-220 (7500g MF) matrix in symptomatic adult CRS patients who have previously had bilateral ethmoid sinus surgery during a 24-week period. The trial is divided into two parts: Part 1 was aimed to examine the feasibility and tolerability of two 7500µg MF matrix designs; in Part 2, 40 patients were randomly assigned 1:1 to receive LYR-220 or sham control.
Lyra revealed positive preliminary findings from the BEACON trial's Part 1, the non-randomized portion, in September 2022, indicating the feasibility and tolerability of bilateral LYR-220 placement in this patient population. In addition, all six patients were given the medication for at least six weeks, and no significant or unexpected side effects were recorded.
Although efficacy evaluation was not the goal of the trial's uncontrolled Part 1 stage, there was a mean improvement of 21 points (37%) from baseline in the 22-item Sino-nasal Outcome Test (SNOT-22) total score at six weeks. This is more than double the minimal clinically significant difference of 8.9 points.
About Lyra Therapeutics
Founded in 2018, Lyra Therapeutics is a clinical-stage firm pioneering a novel therapeutic approach for the treatment of debilitating ear, nose, and throat (ENT) diseases that affect millions of people. Its mission is to change the ENT treatment paradigm by giving physicians effective front-line solutions and innovative therapy alternatives for their patients. The company is working on therapeutics for the localized treatment of chronic rhinosinusitis patients (CRS). Lyra has two investigational product candidates, LYR-210 and LYR-220, in late-stage development for CRS, which is a common inflammatory disease of the paranasal sinuses that causes debilitating symptoms and significant morbidities. It is headquartered in the Boston region and was created by academic luminaries in the disciplines of chemistry, materials science, and biotechnology, and is supported by top life science investors.
BUSINESS INSIGHTS, PHARMACY MARKET
VERO Biotech | February 03, 2023
On February 2, 2023, VERO Biotech Inc., a commercial-stage biotechnology company focused on neonatal intensive care and the acute care hospital community, announced that FDA has approved its innovative second-generation GENOSYL® Inhaled Nitric Oxide (iNO) delivery system for use in the operating room with rebreathing anesthesia. The second generation GENOSYL® DS is now the first and only iNO delivery device approved for use in both rebreathing and non-rebreathing anesthesia procedures, enhancing patient care, saving money for the hospital, and minimizing waste anesthetic gas pollution.
GENOSYL® DS is the first tankless inhaled nitric oxide delivery system. Nitric oxide, when inhaled, dilates the pulmonary blood vessels and can improve oxygenation in neonates suffering from hypoxic respiratory failure and pulmonary hypertension. GENOSYL® DS, unlike tank-based systems, generates and delivers iNO at the bedside via a small disposable cassette. This helps eliminate the need for hospitals to manage large, cumbersome tanks while also aiding in the simplification of clinical workflow.
The following are the expected advantages of the second generation GENOSYL® DS
Ability to employ rebreathing anesthesia: Rebreathing allows reduced gas flows, resulting in less usage of expensive anesthetic drugs, thereby reducing hospital costs; enhanced patient comfort (by preserving patient body temperature and moisture).
Smoother care process: seamless iNO delivery from the ICU to surgery and post-operative care leads to process and workflow enhancements for the healthcare organization, thus lowering the hospital's overall cost.
Set and forget: It allows anesthesiologists to continue using rebreathing anesthesia, thereby preventing potentially dangerous, time-consuming and cumbersome workarounds.
Reduced ecological consequences of anesthesia delivery: less anesthetic is released into the environment.
It is important to note that FDA has only approved the second generation GENOSYL® DS for use with rebreathing anesthesia in the surgical suite. The third generation GENOSYL® DS, which was recently approved, has not been tested with rebreathing anesthesia. VERO Biotech is currently conducting similar validations and expects to have data available in the first quarter of 2023.
About VERO Biotech
Headquartered in Atlanta, GA, VERO Biotech is an emerging biotechnology firm that focuses on designing, developing, and commercializing next-generation inhaled nitric oxide (NO) delivery systems to tackle unmet medical needs in patients with cardiopulmonary conditions. The company's mission is to improve patients' lives by pioneering innovative technologies for inhaled NO delivery in acute care hospitals and beyond, wherever nitric oxide treatment is required. By focusing on the science, development, and commercialization of its innovations, it aims to exceed customer expectations regarding safety, efficacy, and growth.
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.