PLx Pharma Inc. | September 13, 2022
PLx Pharma Inc. is a commercial-stage drug delivery platform technology company focused on its clinically-validated and patent-protected PLxGuard™ that has the potential to improve the absorption of many drugs currently on the market and to reduce the risk of stomach injury associated with certain drugs. The Company, with its lead products VAZALORE 81 mg and VAZALORE 325 mg liquid-filled aspirin capsules has launched a new VAZALORE 325 mg advertising campaign on Facebook featuring legendary professional baseball pitcher and avid golfer John Smoltz.
“From baseball to golf, I don’t want aches and pains to slow me down,” said Smoltz. “VAZALORE is the only pain reliever I have found that works quickly on my aches and pains and doesn’t upset my stomach.”
“September is Pain Awareness Month, a time dedicated to raising awareness of pain and pain management options, like aspirin. We are very excited to launch our new Facebook campaign with John, a current VAZALORE user and believer in its many benefits. Millions of people rely on aspirin for the temporary relief of minor aches and pains. The unique complex inside VAZALORE capsules allows for targeted release of aspirin to temporarily relieve minor aches and pains and is specially designed to help protect the stomach.”
Natasha Giordano, President & CEO of PLx Pharma
PLx Pharma’s VAZALORE is the first and only U.S. Food and Drug Administration (FDA)-approved liquid-filled aspirin capsule. The product was launched in August 2021 and is available over the counter in more than 30,000 drugstores, supermarkets, mass merchandisers and e-commerce sites nationwide.
VAZALORE is an FDA-approved liquid-filled aspirin capsule, available in 81 mg and 325 mg doses. VAZALORE delivers aspirin differently from plain and enteric coated aspirin products. The special complex inside the capsule is designed for targeted release of aspirin, limiting its direct contact with the stomach. VAZALORE delivers fast, reliable absorption for pain relief plus the lifesaving benefits of aspirin.
About PLx Pharma Inc.
PLx Pharma Inc. is a commercial-stage drug delivery platform technology company focused on improving how and where active pharmaceutical ingredients (APIs) are absorbed in the gastrointestinal (GI) tract via its clinically validated and patent protected PLxGuard™ technology. PLx believes this platform has the potential to improve the absorption of many drugs currently on the market or in development, and to reduce the risk of stomach injury associated with certain drugs.
Athira Pharma, Inc. | October 18, 2022
Athira Pharma, Inc. a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration, today announced that following an unblinded interim efficacy and futility analysis, an independent data monitoring committee recommended continuation of the LIFT-AD study of fosgonimeton in patients with mild-to-moderate Alzheimer’s disease. The committee also determined that, with the additional enrollment of fewer than 150 patients for a total enrollment of less than 300 patients without background therapy the study will be well powered for the primary endpoint given the preliminary effect size observed. The primary endpoint of LIFT-AD is the Global Statistical Test, an unweighted composite score comprising measures of cognition and function.
Results from the completed exploratory ACT-AD Phase 2 study showed a favorable safety profile and suggested positive effects on measures of cognition function and neurodegeneration in patients taking fosgonimeton without background therapy. Guided by these results, the Company proactively amended LIFT-AD to focus on patients not on background therapy. The unblinded interim analysis was then conducted in approximately 100 patients not on background therapy to corroborate observations from ACT-AD and ensure LIFT-AD is well powered to determine the effect of fosgonimeton on clinically meaningful and commercially relevant endpoints.
“The results from the data monitoring committee’s unblinded analysis give us confidence in a potentially positive outcome for LIFT-AD, as stringent evaluation criteria were applied based on validated and clinically meaningful cognitive and functional outcomes. This analysis supports the potential clinical benefits of fosgonimeton treatment and underscores the rationale for continued development of this promising new therapy.”
Hans Moebius, M.D., Ph.D., Chief Medical Officer of Athira
“We are very excited by the results of this independent review as we believe they mitigate the risk of the fosgonimeton development plan, support the potential clinical benefit of fosgonimeton and inform the sample size needed to achieve success with LIFT-AD,” said Mark Litton, Ph.D., President and Chief Executive Officer of Athira. “We are now targeting to complete enrollment in mid-2023 and report topline data in early 2024. Importantly, we have a strong balance sheet to execute our plans through key data readouts and beyond. Moving forward, we remain keenly focused on advancing this novel investigational therapy with the hope of positively impacting the lives of millions of Alzheimer’s patients.
“Our goal with fosgonimeton is to demonstrate its ability to improve cognition and function and to ultimately provide neuroprotection. The ACT-AD study suggested these benefits, and the results of the LIFT-AD interim analysis corroborate those findings,” added Dr. Litton. “We believe any drug that can demonstrate neuroprotection could become a treatment of choice for mild-to-moderate Alzheimer’s patients.”
About the LIFT-AD Clinical Study
LIFT-AD is a randomized, double-blind, placebo-controlled, parallel-group study of fosgonimeton for patients with mild-to-moderate Alzheimer’s disease. Patients are randomized across two dose groups and one placebo group on a 1:1:1 basis to receive a subcutaneous injection of fosgonimeton or placebo once daily over a treatment course of 26 weeks. The primary endpoint for LIFT-AD is the Global Statistical Test, an unweighted composite score comprising measures of cognition (Alzheimer's Disease Assessment Scale-Cognitive Subscale and function. Additional information on the LIFT-AD study can be found at: NCT04488419.
Fosgonimeton is a small molecule designed to enhance the activity of hepatocyte growth factor (HGF) and its receptor, MET, to impact neurodegeneration and regenerate brain tissue. The function of the HGF/MET receptor system may be impaired in the brain under conditions of neurodegeneration. In addition to Alzheimer’s disease, fosgonimeton has the potential to address the broader dementia population, including Parkinson’s disease dementia and Dementia with Lewy bodies, as the mode of action focuses on network recovery and synaptic signal transmission in the brain.
The ACT-AD trial was supported by a grant from the National Institute on Aging of the National Institutes of Health under Award Number R01AG06268. The information presented in this press release is solely the responsibility of Athira and does not necessarily represent the official views of the National Institutes of Health.
About Athira Pharma, Inc.
Athira Pharma, Inc., headquartered in the Seattle, Washington area, is a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration. Athira aims to provide rapid cognitive improvement and alter the course of neurological diseases with its novel mechanism of action. Athira is currently advancing its pipeline of therapeutic candidates targeting the HGF/MET neurotrophic system for Alzheimer’s and Parkinson’s disease dementia, Dementia with Lewy bodies and neuropsychiatric indications.
Ora, Inc. | September 29, 2022
Ora, Inc., the world's leading ophthalmology clinical research firm, has formally launched a revolutionary mobile research platform, Ora EyeCupTM, which promises to transform patient data capture through high-resolution imaging, artificial intelligence (AI) analysis, and real-time patient feedback. The Ora EyeCupTM, a finalist in the Most Valuable Clinical Technology Award category at the Reuters Events Pharma Awards USA 2022, will be presented by Dr. Gustavo De Moraes, Chief Medical Officer at Ora, at this year’s Eyecelerator Conference in Chicago, IL, September 29th.
The Ora EyeCupTM platform is a powerful combination of hardware and software — a smartphone attachment and software application which allows patients to take high-resolution images of their eyes and track disease signs and symptoms remotely. With over 138,000 images captured to date, 98% are considered gradable by researchers and AI. Post-capture processing utilizes AI-powered image analysis for precise clinical assessments of ocular redness, tear film stability, and corneal health. Along with this, the Ora EyeCupTM ensures protocol adherence through compliance assurance diaries for both symptom tracking and therapy dosing.
“At Ora, our technologists have spent the past two years developing this revolutionary system to capture patient data and provide a deeper understanding of therapeutic effect. The result is a trailblazing technology that captures high quality therapeutic data and improves the likelihood of study success.”
Dr. De Moraes
About Ora, Inc.
Ora is the world's leading full-service ophthalmic drug and device development firm with offices in the United States, United Kingdom, Australia, and Asia. For over 40 years, we have proudly helped our clients earn more than 55 product approvals and create vision beyond what they see. We support a wide array of organizations, from start-ups to global pharmaceutical and device companies, to efficiently bring their new products from concept to market. Ora's pre-clinical and clinical models, unique methodologies, and global regulatory strategies have been refined and proven across thousands of global projects. We bring together the world's most extensive and experienced team of ophthalmic experts, R&D professionals, and operations management to maximize the value of new product initiatives. Think ophthalmology, think Ora.