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.
Lantheus | February 07, 2023
On February 6, 2023, Lantheus Holdings, Inc. (Lantheus), a company dedicated to improving patient outcomes through radiotherapy, diagnostics, and AI solutions that help clinicians to Find, Fight, and Follow® diseases, announced the acquisition of Cerveau Technologies, Inc. (Cerveau).
Cerveau's primary asset is MK-6240, which is a second-gen F 18-labeled positron emission tomography (PET) imaging agent that targets Tau tangles present in Alzheimer's disease.
Alzheimer's disease is a neurodegenerative condition that causes a steady and gradual deterioration in cognition and function. Alzheimer's disease affects an estimated 6.5 million people in the United States. As the population ages, the frequency of this disease is expected to climb further, and by 2050, the number of persons 65 and older with Alzheimer's disease may reach 12.7 million.
MK-6240 is a clinical-stage PET development candidate that is designed to identify Tau protein that accumulates as neurofibrillary tangles in the brains of individuals suffering or suspected of Alzheimer's disease. MK-6240 has the potential to help in Alzheimer's disease diagnosis, staging, treatment selection and response to therapy. Despite being in clinical development, MK-6240 is now being employed in over 60 academic and industrial clinical studies worldwide for various late-stage Alzheimer's disease therapeutic candidates, being explored by more than 16 pharmaceutical firms.
Following the terms of the agreement, Lantheus will make an upfront payment as well as potential further development and commercial milestone payments. It will also pay double-digit royalties on research revenue and commercial sales. In addition, the deal, which is structured as a stock acquisition, stipulates, among other things, that the seller would offer transition and clinical development services for a specified period after the conclusion of the transaction.
In this transaction, Chestnut Partners, Inc. served as the exclusive financial advisor to Cerveau. At the same time, Lantheus was advised by Foley Hoag LLP in connection with the acquisition.
Founded in 1956, Lantheus offers novel diagnostics, targeted medicines, and artificial intelligence (AI) solutions to help clinicians Find, Fight, and Follow® diseases. It has been delivering life-changing research to patients and clinicians for over 60 years, going above and beyond to enhance lives and outcomes. Lantheus Holdings is the parent company of Progenics Pharmaceuticals, Lantheus Medical Imaging, Inc., Inc. and EXINI Diagnostics AB. Headquartered in North Billerica, Massachusetts, the company has offices in New Jersey, Canada and Sweden.
RESEARCH, PHARMA TECH
OM1 | February 06, 2023
OM1, a leading real-world data, results, and technology firm focused on chronic diseases, recently announced the release of its Reasons for Discontinuation (RfD) Analytic Reports. Utilizing the OM1 Real-World Data CloudTM, Immunology Real-World Data Network, and proprietary artificial intelligence (AI) technology, the RfD reports provide difficult-to-obtain, extremely valuable discontinuation trends for cDMARDs, bDMARDs, and tsDMARDs in primary dermatologic and rheumatologic conditions.
Each year, millions of Americans cease their prescriptions prematurely, costing the pharmaceutical industry in the United States an estimated $250 billion in lost income and can affect the health of these patients. Therefore, it is crucial for pharmaceutical businesses to comprehend patient discontinuation patterns so they may act on information regarding tolerability, costs, and emerging contraindications to enhance the patient experience. Prior to this point, it was extremely difficult to extract these insights due to the fact that crucial information was not reflected in claims or any other sort of structured data but was only available in clinical notes.
OM1 is elevating the clinical narrative into actionable insights that pharmaceutical companies can rely on to comprehend patient adherence and clinician prescribing behavior, thanks to its data cloud built on billions of data points from over 300 million patients and unique AI and modeling capabilities. The analyses, which are conducted across multiple strata, such as demographic groups, patient characteristics, medical histories, comorbidities and care pathways, extract insights from the extensive clinical data sets available to OM1 and notes from prescribing clinicians dating back to 2013.
Currently, accessible RfD reports include psoriatic arthritis, rheumatoid arthritis, ankylosing spondylitis, psoriasis, and atopic dermatitis, with more to come, including schizophrenia, depression, and bipolar illness.
Founded in 2015, OM1 is a renowned health outcomes, and registries firm focused on treatment outcome measurement, comparison, and prediction. OM1 created the first intelligent data cloud for healthcare, leveraging big data, standardized outcomes measurement, and artificial intelligence technologies to provide more precise information and improve decision-making for stakeholders across the healthcare ecosystem. The company is reimagining real-world data and evidence in immunology, cardiometabolic, mental health and neurosciences, respiratory and ENT specialty areas by establishing vast electronically connected networks of clinicians and health data.