Kiora: U.S. and European Patents for Local Ocular Delivery of Therapy Compounds

 Kiora Pharmaceuticals, Inc. (NASDAQ: KPRX) ("Kiora" or the "Company") today announced it has been granted U.S. (Patent # 11,730,716) and European Patents covering local ocular delivery of the KIO-100 family of non-steroidal, anti-inflammatory small molecules. This intellectual property (IP) further protects Kiora's pipeline by covering multiple small molecule analogs, delivery methods, and several inflammatory-related therapeutic applications, including posterior non-infectious uveitis, thereby extending market exclusivity for approved indications in the U.S. and Europe.

With these patents issued, Kiora and potential partners can more confidently move forward with the development and commercialization of its KIO-100 family of compounds in combination with optimal delivery routes and formulations. In posterior non-infectious uveitis, the company's KIO-104 product demonstrated promising results in a Phase 1b clinical study demonstrating decreased retinal inflammation in a dose dependent fashion and significantly improved visual acuity compared to historical controls treated with steroids or Humira®.

https://finance.yahoo.com/news/kiora-pharmaceuticals-granted-u-european-110000476.html

GRI to Sell ADAIR Asset

 Aardvark to acquire global development and commercialization rights to ADAIR and all intellectual property outside of Europe and licensor rights for the EU

Aardvark to leverage ADAIR formulation technology for certain follow-on pipeline programs in development

GRI to receive modest upfront payment and potential to earn development and commercial milestones up to approximately $80 million

 GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio” or the “Company”), a biotechnology company advancing an innovative pipeline of Natural Killer T (“NKT”) cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, today announced that the Company has entered into an asset purchase agreement pursuant to which Aardvark Therapeutics, Inc. (“Aardvark”) will acquire certain assets and intellectual property of the Company that pertain to ADAIR (Abuse Deterrent Amphetamine Immediate Release). Aardvark intends to utilize the ADAIR formation technology for the development of certain follow-on pipeline programs.

ADAIR, a legacy asset from the merger with Vallon Pharmaceuticals, Inc. (“Vallon”), is a proprietary abuse-deterrent formulation of immediate release dextroamphetamine for the treatment of attention deficit hyperactivity disorder (“ADHD”) designed to deter attempts to crush and snort it or take it by other non-oral routes that can produce a greater “high.”

Under the terms of the agreement, Aardvark will assume responsibility for and endeavor to develop and commercialize the purchased assets. Exclusive license rights to develop and commercialize ADAIR in Europe and the UK were previously licensed to Medice Arzneimittel Pütter GmbH, a leader in the European ADHD market. GRI Bio will receive a modest up-front payment and the potential to earn milestone payments for achievements in development and commercialization from Aardvark up to approximately $80 million.

https://finance.yahoo.com/news/gri-bio-enters-asset-purchase-130000808.html

Fresenius: FDA Clears Home Dialysis System

 Fresenius Medical Care, the world's leading provider of products and services for individuals with renal diseases, today announced the U.S. Food and Drug Administration (FDA) 510(k) clearance for Versi®HD with GuideMe Software, a completely reinvented self-guided interface for the company's VersiHD chronic home hemodialysis (HHD) system. VersiHD with GuideMe Software aims to transform the experience of HHD for patients and nurses.

As the established leader in HHD, NxStage from Fresenius Medical Care, draws on its experience of over 30 million patient treatments at home over nearly two decades, serving patients in more than 45,000 homes with a broad diversity of water sources across the U.S.

VersiHD with GuideMe Software provides graphical walk-through guidance that aims to enhance ease of use and confidence for both patients and nurses. It is designed to improve patient training time, ease the transition to home, and make the training experience easier for new users.

https://finance.yahoo.com/news/fresenius-medical-care-announces-fda-130100100.html

Relmada Starts Phase 3 Trial of REL-1017 for Adjunctive Treatment of Major Depressive Disorder

 Relmada Therapeutics, Inc. (Nasdaq: RLMD), a late-stage biotechnology company addressing diseases of the central nervous system (CNS), today announced the dosing of the first patient in the Relight (study 304) Phase 3, randomized, double-blind, placebo-controlled trial evaluating REL-1017 as an adjunctive treatment of Major Depressive Disorder (MDD).

https://www.biospace.com/article/releases/relmada-therapeutics-announces-dosing-of-first-patient-in-relight-a-phase-3-trial-of-rel-1017-for-the-adjunctive-treatment-of-major-depressive-disorder/

Alterity Granted Patent in Europe for Neurodegenerative Diseases including Parkinson’s, Alzheimer’s

 Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the Company”), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today announced the European Patent Office has granted Alterity a new composition of matter patent.

The patent secures broad protection over a new class of iron chaperone drug candidates for treating major neurodegenerative diseases. It is well established that excess iron in the brain is implicated in the pathology of many important neurodegenerative diseases, including Alzheimer’s and Parkinson’s diseases.¹

^{https://www.biospace.com/article/releases/alterity-therapeutics-granted-new-composition-of-matter-patent-in-europe-for-neurodegenerative-diseases-including-parkinson-s-and-alzheimer-snew-patent-covers-over-150-novel-compounds/}

Letter To CDC: Epidemiologist Suggests Misrepresented Scientific Data To Back Mask Narrative

 by Megan Redshaw via The Epoch Times (emphasis ours),

Documents recently obtained from the National Institutes of Health suggest public health officials used inaccurate information and misrepresented medical research to advance their policy objective that masks prevent severe COVID-19 and virus transmission—despite opposing scientific evidence received from experts.

In a recently obtained letter (pdf) sent in November 2021 to the Centers for Disease Control and Prevention (CDC), top epidemiologist Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, and seven colleagues informed the agency it was promoting flawed data and excluding data that did not reinforce their narrative.

The letter warned the agency that misrepresenting data on trusted websites such as the CDC and the COVID-19 Real-Time Learning Network—jointly created by the CDC and Infectious Diseases Society of America (IDSA)—would “damage the credibility of science,” endanger public trust by “misrepresenting the evidence,” and give the public “false expectations” masking would protect them from the SARS-CoV-2 virus that causes COVID-19.

“We believe the information and recommendations as provided may actually put an individual at increased risk of becoming infected with SARS-CoV-2 and for them to experience a serious or even life-threatening infection,” Mr. Osterhom wrote.

The authors urged the IDSA to remove the suggestion that masking prevents severe disease from its website and asked the CDC to reconsider its statements about the “efficacy of masks and face coverings for preventing transmission of SARS-CoV-2.”

Osterholm also noted a pattern of selectively choosing data that supported the desired narrative that masks prevent severe COVID-19 disease and transmission—claims he said are unsupported by the scientific evidence provided by the CDC and IDSA on their websites.

The IDSA “Masks and Face Coverings for the Public” webpage appears to “focus on the strengths of studies that support its conclusions while ignoring their shortcomings of study design,” Mr. Osterholm wrote. “Studies that do not support its perspective are similarly downplayed.”

The COVID-19 Real-Time Learning Network was created in 2020 to share “accurate, timely information about COVID-19.” According to its website, the IDSA’s editorial team of infectious disease and public health experts synthesize clinical guidance, identify emerging scientific consensus and areas of ongoing uncertainty, and tackle “misconceptions and disinformation.”

Although partly funded by the CDC, the IDSA collaborates with numerous medical professional organizations that publish medical journals and make recommendations based on agency guidance, including the American Academy of Family Physicians, the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, the American College of Physicians, the Society of Critical Care Medicine, the Society for Healthcare Epidemiology of America, and the Society of Infectious Diseases Pharmacists.

The letter was sent to CDC officials, the associate medical and associate digital editors of the COVID-19 Real-Time Learning Network, and IDSA board members, which included Dr. Rochelle Walensky, the former director of the CDC during the COVID-19 pandemic.

Experts Ask CDC and IDSA to Address ‘Serious Errors’ on Website

In his letter to the CDC, Mr. Osterholm asked the CDC and IDSA to address the “serious errors” published on its website regarding the efficacy of masks as soon as possible and strongly urged the IDSA to remove the suggestion that masking prevents severe COVID-19 from its website and a podcast where such “irresponsible claims were made.”

Furthermore, Mr. Osterholm recommended the IDSA reconsider statements about the efficacy of masks and coverings for preventing SARS-CoV-2 transmission, noting the IDSA’s website falsely suggests evidence of mask efficacy has strengthened throughout the pandemic.

“We do not agree that the evidence for their efficacy has strengthened throughout the pandemic, as the website suggests,” Mr. Osterholm said. “In fact, contrary to the conclusion on this website, the November 2020 Cochrane Review cited states this: ‘Compared with wearing no mask, wearing a mask may make little to no difference in how many people caught a flu-like illness (9 studies; 3,507 people); and probably makes no difference in how many people have flu confirmed by a laboratory test (6 studies; 3,005 people).'”

https://www.zerohedge.com/political/secret-letter-cdc-top-epidemiologist-suggests-agency-misrepresented-scientific-data

'Canada Wildfire Smoke Exposure Not Much Worse Than Bad Pollen Day in NYC'

 New Yorkers can apparently breathe a sigh of relief, at least for now. Their exposure to the smoke in June 2023 from Canadian wildfires led to only a slightly higher bump in visits to New York City hospital emergency departments for breathing problems or asthma attacks than what is seen on days when pollen counts are high. However, authors of a new study say other possible health effects, such as possible heart attacks and stroke, still need to be investigated.For the study, researchers at NYU Grossman School of Medicine analyzed daily levels of air pollution, as measured by the presence of tiny particles known as particulate matter 2.5, which can if lodged deep in the lungs lead to inflammation, as well as respiratory and heart problems.

When researchers assessed air pollution levels for the first six months of 2023, including months of regular ambient (or general background) air pollution and the days in June when wildfire smoke peaked, they found that wildfire smoke led to a 3% average increase in asthma-related visits to emergency departments across all city hospitals (for every 10 microgram increase in PM 2.5 per cubic meter of air).

When wildfire smoke was at its worst on June 7, 2023 (at a PM 2.5 of 146 micrograms per cubic meter of air), citywide asthma-related emergency visits peaked at 335, up from a daily average of 188 per day earlier in the year, when the skies were clear of wildfire smoke.

By comparison, they say this peak wildfire number is only slightly higher than the 302 asthma-related emergencies seen on April 26, 2023, when the level of tree pollen, another lung irritant and known asthma trigger, was high (at tree pollen counts above 1,500 per cubic meter of air).

The researchers caution that while no deaths tied to the wildfire smoke were reported in June, asthma remains a serious and potentially life-threatening lung disease.

"Thankfully, the respiratory effects of the wildfire smoke in June were not much worse than what had been seen on really bad pollen days back in the spring, and despite what many New Yorkers may have feared on seeing hazy, orange air," said study co-investigator Wuyue Yu, a doctoral student at NYU Langone Health.

Yu says the latest findings, published in the American Journal of Respiratory and Critical Care Medicine online Aug. 15, mirror those seen with increases in ambient air pollution and pollen seen elsewhere, and their effects on asthma-related hospital emergencies.

"Still, the long-term consequences, if any, of exposure to wildfire smoke remain unknown, so we are not yet totally in the clear," said study co-investigator David Luglio, a doctoral student at NYU Langone Health.

Researchers say they already have study plans for further air monitoring and for comparing the health effects of exposure to wildfire smoke to particulate matter more commonly inhaled from fossil-fuel combustion, which he says is more dangerous.

"While inhaling any particle-filled air is not good for your lungs, we do know that wildfire smoke is primarily made up of organic matter," said senior study investigator George Thurston, ScD, a professor in the Departments of Medicine and Population Health at NYU Langone. "As a result, it is not enriched in the toxic metals that are found in fossil-fuel emissions, which are known to cause damaging oxidative stress in the body."

Indeed, Thurston says this was reflected in other study results, which showed that the wildfire smoke contained 64% more potassium than ambient air pollution, with potassium a key component to soil and foliage. By contrast, the wildfire smoke contained just 12% of the average levels of copper present in background air pollution and 26% of the average levels of sulfur observed in the ambient air. Both are found in average New York City air and are known causes of oxidative stress when inhaled.

For the study, which was funded by NYU Langone, researchers used hospital patient data supplied by the New York City Department of Health and Mental Hygiene. Pollution and pollen data was in part supplied by the New York State Department of Environmental Conservation, which maintains multiple air-monitoring stations across the city, and by air sampling performed by the study team.

https://www.biospace.com/article/releases/despite-fears-to-the-contrary-canadian-wildfire-smoke-exposure-was-not-much-worse-than-a-bad-pollen-day-in-new-york-city/