Galimedix Therapeutics, Inc. To Present at Ophthalmology Innovation Summit During the American Academy of Ophthalmology Meeting

KENSINGTON, Md. and SHORASHIM, Israel , Oct. 08, 2019 (GLOBE NEWSWIRE) — Galimedix Therapeutics, Inc., which is developing new solutions for neurodegenerative diseases of the retina and the brain, today announced that Chief Scientific Officer, Hermann Russ, M.D., Ph.D., will provide an overview of the company and of the new development strategy with its novel, first–in–class, investigational compound, GAL–101 at the Ophthalmology Innovation Summit at the American Academy of Ophthalmology Annual Meeting (OIS@ AAO) on October 10, 2019 in San Francisco.

GAL–101 is a small molecule and has a unique mechanism of action targeting amyloid beta oligomers in an unprecedented way. There is a growing body of evidence that the toxic amyloid beta oligomers represent a major pathological factor leading to functional loss and neurodegeneration in the retina of glaucoma and dry AMD patients. GAL–101 blocks the formation of the toxic amyloid beta oligomers at source, prevents in vitro lethal toxicity to neurons and shows pronounced neuroprotective effects in animal models. "In addition, we now have demonstrated that GAL–101 can also restore neuronal function in cells that have lost their function under the toxic influence of amyloid beta oligomers" says Dr. Russ, who will present these data.

Based on the new data on functional restoration, Galimedix now plans to conduct clinical Phase 2 studies with GAL–101 eyedrops in glaucoma and dry AMD patients. Given the drug's mechanism for clearing the toxic amyloid beta oligomers from the retinas of patients with either glaucoma or dry AMD, the goal is to prove that the GAL–101 eyedrops cause an improvement of visual function, as measured by visual fields or by microperimetry, respectively. "We have made great progress in the development of our asset and are convinced this is a unique opportunity to provide superior treatment options to patients with degenerative retina diseases in the future" states Dr. Andrew Pearlman, Founder and CEO of Galimedix Therapeutics, Inc.

About GAL–101
GAL–101 is a proprietary compound designed to prevent the formation of all forms of toxic amyloid beta oligomers by binding with high affinity to only the misfolded form of amyloid beta monomers before they can form toxic soluble oligomers. These then rapidly conglomerate into amorphous, non–beta–sheet formations, which we call "clusters," which are innocuous. Interestingly, once GAL–101 concentration reaches effective levels it triggers formation of the clusters, which then have shown the capacity to collect additional misfolded amyloid beta monomers even in the absence of additional GAL–101 molecules, through a self–propagating mechanism. This novel "trigger effect," protected by Galimedix' patent portfolio, results in a sustained effect lasting far longer than the time a single administration of the drug remains at therapeutic levels in the retina, potentially allowing for a convenient interval application regimen for patients. Thus, GAL–101 drops may potentially provide sustained prevention of formation of toxic amyloid beta oligomers in the retina, leading to a reduction of complement response and their consequent damage. Thus GAL–101 could contribute to slowing or stopping progression, and possible restoration of neural function depressed by the chronic toxic attack.

About Galimedix Therapeutics, Inc.
Based in the United States and Israel, Galimedix is a Phase 2–ready ophthalmic pharmaceutical company with a world class drug development team advancing a novel, patented small molecule drug with a novel MOA addressing glaucoma and dry AMD utilizing an eye drops delivery platform, which may offer significant safety and compliance advantages over commonly used direct ocular injections. Eye drops are used to deliver steroids and other small molecules, like GAL–101, to the retina, and studies with Galimedix's eye drops in monkeys have demonstrated therapeutic levels quickly reaching the retina of the closest model to humans. Compelling efficacy data from GAL–101 eye drops in relevant animal models have demonstrated more than 90 percent neuroprotection, and the compound is supported by several leading experts in glaucoma and in dry AMD who also support the design of the company's proposed Phase 2 studies.

Galimedix has exclusive worldwide license from Tel Aviv University, following return of license by a German pharma (Merz) due to management change and strategic pivot away from neuroscience. The license also includes a next generation, potentially superior molecule intended for oral delivery, with potential to treat retinal and other CNS diseases.

Contact:
Jules Abraham
Core IR
julesa@coreir.com
917–885–7378

Beware High-Fat Diets

By Wan Manan Muda and Jomo Kwame Sundaram
KUALA LUMPUR, Malaysia, Oct 8 2019 – Two decades into the 21st century, all too many people still associate being ‘overweight’ with prosperity, health and wellbeing, mainly because being thin has long been associated with being emaciated due to hunger, undernourishment and malnutrition.

Overweight and obesity can easily be assessed by anthropometric measures, including the body mass index (BMI) and waist circumference. But BMI thresholds for overweight and obesity may differ by ethnic group or country.

Wan Manan Muda

The standard World Health Organization (WHO) BMI cut-off for overweight is 25, while the threshold for obesity is 30, understood as an abnormally high percentage of fat, which can be either generalized or localized.

Obesity pandemic
In 2014, McKinsey Global Institute estimated 2.1 billion overweight people, including the obese, then almost 30% of the world’s population. The related economic burden was estimated to be over US$2 trillion, a close third to civil conflicts and smoking.

By 2016, an estimated 1.97 billion adults and over 338 million children and adolescents worldwide were categorized as overweight or obese, following the rapid increase in overweight, including obesity, in recent decades.

An estimated 6% of children under 5 years of age were overweight in 2016, up from 5.3% in 2005. Similarly, the prevalence of overweight and obesity among adults rose by 27% between 1980 and 2013.

The situation in many middle-income developing countries is especially dire as higher incomes and more food consumption have reduced hunger while worsening other forms of malnutrition, including ‘hidden hunger’ or micronutrient deficiencies. The resulting health condition of much of the population generally imposes heavy costs for themselves, their families and their nations, while reducing their incomes.

Role of the brain
Obesity is typically due to nutrient imbalances where food ingested is stored as fat, instead of being utilized for energy and metabolism. Epidemiological evidence suggests ‘high fat’ and carbohydrate diets contribute to obesity, and the relationship between dietary fat and the degree of obesity.

Jomo Kwame Sundaram

Although there is now a near consensus that unhealthy diets worsen obesity and health, less is known about neurological changes to the brain due to such diets. Recent research finds that high-fat diets — specifically those with considerable fats and carbohydrates — contribute to irregularities in parts of the brain regulating body weight.

A recent study found that high-fat diets stimulate inflammation in the brains of mice, triggering physical changes in such cells, and encouraging the mice to eat more and become obese. As this happens before the body displays signs of obesity and body weight changes, it implies that high-fat diets induce the brain to want to eat more.

Thus, it is possible that high-fat diets may not just affect humans physically, but also alter food intake neurologically. Hence, it is detrimental when food rich in fat and carbohydrates is easily available, encouraging even more eating.

Health threats
Many factors contribute to obesity, including lifestyle, diet, individual genetics and gut bacteria. Besides high fat and carbohydrate diets, immune system activity can also contribute to obesity, although details remain unclear.

The presence of large numbers of fat cells changes micro-biomes inside the body, causing the body to respond negatively. Worryingly, obesity has been closely linked to various chronic diseases including cardiovascular disease, diabetes and other metabolic disorders.

Recent research also clarifies how they affect various diseases of the brain, including Alzheimer’s, a neurological disorder associated with changes in brain cells more prevalent among the obese.

Such evidence continues to grow. Therefore, high fat diets have not only contributed to the developing world’s overweight and obesity pandemic, but may also have caused damage to brains and brain functioning.

Prevention better than cure
Changing diets, food consumption and human behaviour have all contributed to the nutrition transition and obesity pandemic.

While the developing world makes slow progress in overcoming hunger, or dietary energy undernourishment, much more needs to be done to educate the public about problems of malnutrition besides macronutrient deficiencies.

Micronutrient deficiencies, or ‘hidden hunger’, as well as diet-related non-communicable diseases also need to be addressed.

Already, those associated with overweight and obesity have been growing rapidly to pandemic proportions in recent decades, mainly due to dietary and other behavioural changes.

The authors recently co-authored Addressing Malnutrition in Malaysia available at: www.krinstitute.org