Preclinical Studies Demonstrate Galimedix Therapeutics’ Investigational Compound GAL-101 Shows Neuroprotective Effect from Toxic Amyloid-Beta in Dry AMD and Glaucoma Models
Poster Presented at the Association for Research in Vision and Ophthalmology Annual Meeting
KENSINGTON, Md. and SHORASHIM, Israel, May 08, 2019 (GLOBE NEWSWIRE) -- Galimedix Therapeutics, which is developing new solutions for ophthalmic and neurodegenerative diseases, today presented data demonstrating its novel, first-in-class, investigational compound GAL-101 provides neuroprotection from misfolded amyloid beta molecules aggregating into toxic forms in vitro, neutralizing their ability to be toxic to neural tissues. Further, investigators discovered that peak levels from a single delivery of the compound may provide sustained detoxification. The poster was presented at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting in Vancouver, British Columbia, Canada from April 28 to May 2, 2019.
“The unique mechanism of action of GAL-101 has been shown to reduce the levels of amyloid beta present in the retina, thereby both preventing neurodegeneration and increasing the chances of preventing vision loss. However, this poster further demonstrates that a single peak administration of the compound by eye drops may also provide a sustained detoxifying effect in dry AMD and glaucoma patients,” commented Dr. Hermann Russ, lead author of the paper and Chief Scientific Officer of Galimedix. “These preclinical data, combined with a positive result in the Phase 1 study have made it possible for us to move rapidly toward a Phase 2 program for which we will provide updates when available.”
In the poster, investigators reported that eye drops of GAL-101 in repeated monkey models resulted in concentrations in the retina rapidly reaching levels far in excess of the threshold for initiating the peak-related pharmacological effect, and remained in those levels for at least four hours. Furthermore, in age-related macular degeneration (AMD) mouse models with substantial amyloid beta deposits in the retina accumulated during many months, GAL-101 eye drops when given for 1-3 months resulted in substantially less amyloid beta deposits, and simultaneously reduced the levels of C-complement response, which is considered a central factor leading to the progression of dry AMD.
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 the misfolded 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-propagation 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.
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.
One Liberty Plaza - 165 Broadway
NY 10006 New York
GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.
Subscribe to releases from GlobeNewswire
Subscribe to all the latest releases from GlobeNewswire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from GlobeNewswire
NEW ANALYSES OF PHASE 2 EQUATOR CLINICAL PROGRAM SUPPORT DURABLE EFFICACY OF FILGOTINIB IN PSORIATIC ARTHRITIS5.6.2020 22:01:00 CEST | Press release
-- Data Were Presented at the European League Against Rheumatism, EULAR, European E-Congress of Rheumatology 2020 -- Foster City, Calif., & Mechelen, Belgium, 5 June 2020, 22.01 CET – Gilead Sciences, Inc. (Nasdaq: GILD) and Galapagos NV (Euronext & Nasdaq: GLPG) today announced new analyses from two clinical trials evaluating filgotinib, an investigational, oral, selective JAK1 inhibitor, in adults with psoriatic arthritis (PsA). The data from the double-blind, placebo-controlled, Phase 2 EQUATOR study and the EQUATOR-2 open-label extension study demonstrate filgotinib’s durable efficacy and consistent safety profile in people with active PsA, and showed rapid and sustained reductions in inflammatory biomarkers in patients with moderate to severe PsA. The new analyses were presented at the European League Against Rheumatism, EULAR, European E-Congress of Rheumatology 2020. “Despite existing treatments, people living with psoriatic arthritis can face challenging long-term symptoms incl
Agility receives order from new major global logistics customer for CNG trucks5.6.2020 20:19:33 CEST | Press release
Agility Fuel Solutions, a business of Hexagon Composites, has signed a master services agreement with a global logistics customer to deliver compressed natural gas (CNG) fuel systems for medium and heavy-duty trucks. The initial order represents an estimated total value of USD 2.2 million (approx. NOK 20.5 million) with additional orders expected to follow. As a low carbon fuel, CNG can result in reductions of greenhouse gas (GHG) emissions compared to diesel of over 20% when using conventional natural gas, or 90% or more when using renewable natural gas (RNG) produced from landfills, dairy farms and other bio sources. “It makes environmental and economic sense to deploy CNG trucks right now, and the low cost and maturity of the technology make it possible to do so at scale,” says Seung Baik, President, Agility Fuel Solutions. Deliveries of the first order of CNG fuel systems are scheduled to start in the second quarter of 2020. For more information: David Bandele, CFO, Hexagon Composi
Hexagon Composites ASA: Mandatory Notification of Trade5.6.2020 17:11:41 CEST | Press release
Dan Krick, SVP Organizational Development has sold 24,896 shares in Hexagon Composites ASA at a price of NOK 36,42 per share. The sale is primarily to finance tax obligations from his exercise of options earlier in the year. After the transaction Dan Krick holds zero shares in Hexagon Composites ASA. This information is subject to the disclosure requirements pursuant to section 5 -12 of the Norwegian Securities Trading Act. For more information: David Bandele, CFO, Hexagon Composites ASA Telephone: +47 920 91 483 | firstname.lastname@example.org About Hexagon Composites Hexagon delivers safe and innovative solutions for a cleaner energy future. Our solutions enable storage, transportation and conversion to clean energy in a wide range of mobility, industrial and consumer applications.
CONDITIONS FOR RIKSBANK BID PROCEDURES SEK GOVERNMENT BONDS5.6.2020 15:05:00 CEST | Press release
Sveriges Riksbank Bid procedure details Government Bonds, 2020-06-12 Maturity dateLoanISIN codeCouponVolume, SEK million2026-11-121059 SE00071259271.00 %1,000 +/- 2502031-05-12 1062 SE00139353190.125 %1,000 +/- 250 Settlement date 2020-06-16 Bids have to be entered by 10.00 on JUN 12, 2020 Highest permitted bid volume: 1 000 SEK million in issue SGB 1059 and 1 000 SEK million in issue SGB 1062 Lowest permitted bid volume: 50 SEK million Bids only through counterparties approved by the Riksbank RESULT OF AUCTION WILL BE PUBLISHED NO LATER THAN 10.10 (CEST) ON JUN 12, 2020. For more information, please contact: Trading desk at the Riksbank + 46 8 696 6970 General and special terms and conditions can be retrieved athttp://www.riksbank.se
Correction: Correction: Correction: AB Klaipedos nafta financial information reporting dates in 20205.6.2020 15:05:00 CEST | Press release
Correction: AB Klaipedos nafta social responsibility report for the year 2019 will be released on 9 June 2020. AB Klaipedos nafta (further – KN) informs that it plans to release financial information in 2020 according to the following schedule: DateReporting informationWithin first 5 working days of every month of 2020KN preliminary revenues* for the previous month31 January 2020Interim financial information for the year 20196 April 2020Audited financial statements for the year 201929 April 2020Interim financial information for the 1st quarter of 20209 June 2020Social responsibility report for the year 201931 July 2020Interim financial information for the 6 month of 202030 October 2020Interim financial information for the 3 quarters of 2020 On 28 April 2020, the Company plans to convene an Ordinary General Meeting of Shareholders. * It should be noted that from 2020 the company will be adjusting course of releasing monthly financial information. As range of the services provided to the
Medtronic Resolute Onyx™ DES Receives First and Only One-Month DAPT Indication for High Bleeding Risk Patients in Europe5.6.2020 15:00:10 CEST | Press release
DUBLIN, June 05, 2020 (GLOBE NEWSWIRE) -- Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced it has received CE (Conformité Européenne) Mark for a one-month dual antiplatelet therapy (DAPT) indication for high bleeding risk (HBR) patients implanted with the Resolute Onyx™ Drug-Eluting Stent (DES). For HBR patients, whose bleeding risk may be increased by taking longer DAPT regimens (a combination of aspirin and anti-clotting medication), this new, first-of-its-kind indication allows physicians to recommend a shorter, one-month regimen of DAPT, following a percutaneous coronary intervention (PCI) with Resolute Onyx. The approval is the first of its kind globally. Resolute Onyx DES is available for use in the United States, as well as in Europe and other countries that recognize the CE Mark. Resolute Onyx DES is not currently indicated for HBR patients with one-month DAPT in the United States. Data have been submitted to the FDA with the intent of obtainin