Veralox Therapeutics Announces Favorable Results of Phase 1 Studies of VLX-1005
for Treatment of Heparin-Induced Thrombocytopenia
FREDERICK, Md., June 13, 2022 /PRNewswire/ -- Veralox Therapeutics, a biotechnology company developing first-in-class small molecule therapeutics that treat serious immuno-inflammatory diseases with significant unmet medical needs, today announced favorable results from the Company's Phase 1 clinical program for VLX-1005, a novel 12-LOX inhibitor being developed for the treatment and prevention of heparin-induced thrombocytopenia and thrombosis (HIT). Veralox also announced that VLX-1005 has been awarded Fast Track Designation by the U.S. Food and Drug Administration (FDA).
"Completion of our Phase 1 study for VLX-1005 together with announcement of Fast Track Designation for this program represent important milestones that reflect the new levels of momentum we are achieving with our clinical strategy at Veralox," said Michael Hanna, Chief Medical Officer at Veralox. "We look forward to continuing our development of VLX-1005 to address the underlying pathology of HIT, a disease that has not seen innovation in available therapies in over 20 years."
Veralox completed a Phase 1a study consisting of a single ascending dose (SAD) portion and a multiple ascending dose (MAD) portion that was designed to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of VLX-1005. In this study VLX-1005 was found to be well tolerated with no reports of serious adverse events (SAEs), dose-limiting toxicities (DLTs) or discontinuations; adverse events (AEs) were infrequent and mild. Data analyses revealed dose linear increases in key PK metrics approaching dose proportionality with no upper limits on tolerability to the maximum dose tested.
Veralox also completed a Phase 1b drug-drug interaction (DDI) study of VLX-1005 in conjunction with argatroban, an anticoagulant that is approved for the treatment of HIT in the U.S. This study was designed to evaluate the effects of coadministration of VLX-1005 and argatroban on subject safety and on a range of exploratory biomarkers. The study showed that co-administration of VLX-1005 with argatroban was well tolerated with no SAEs; AEs were infrequent and mild. Preliminary analysis of the PK and PD (as measured by APTT) data revealed no evidence of DDI.
The FDA granted Fast Track designation for the VLX-1005 program on May 27, 2022, following an End-of-Phase 1 meeting with the Agency. The company will use the results of the successful Phase 1 studies as well as the standards inherent in Fast Track designation and previously announced Orphan Drug designation to finalize the design of the planned Phase 2 clinical program for VLX-1005 in HIT.
About Veralox Therapeutics
VERALOX Therapeutics Inc. (https://veralox.com/) is the clinical leader in developing first-in-class therapeutics targeting 12-lipoxygenase, pioneering a new class of therapies that treat the underlying pathologies of serious immune-inflammatory diseases with unmet medical needs. The company's lead candidate, VLX-1005, is in development for the treatment of patients with heparin-induced thrombocytopenia (HIT). Second generation therapeutic products are under development for type 1 diabetes and other immune-mediated and inflammatory diseases.
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U.S. DEPARTMENT OF COMMERCE ANNOUNCES 51 “BUILD TO SCALE” GRANTS TOTALING $47 MILLIONTO FUEL INNOVATION AND TECH-BASED ECONOMIC DEVELOPMENT
Contact: EDA Public Affairs Department, (202) 482-4085
October 5, 2022
WASHINGTON – Today, U.S. Secretary of Commerce Gina Raimondo announced that the Department’s Economic Development Administration (EDA) is awarding 51 “Build to Scale” grants – totaling $47 million – to organizations that support technology entrepreneurs, catalyze innovation and fuel economic growth.
EDA’s “Build to Scale” program provides annual grants that aim to accelerate technology entrepreneurship by increasing inclusive access to entrepreneurial support and startup capital. The 2022 awardees will leverage an additional $48 million in matching funds from a variety of private and public sector sources. These EDA investments support advanced manufacturing, bioscience, clean energy and blue economy clusters in regions throughout the United States.
"Strengthening technology ecosystems are a critical key to the Biden Administration's efforts to build a stronger America,” said Secretary of Commerce Gina Raimondo. “Innovation and entrepreneurship have long been keys to American success and will continue to strengthen our collective economic and national security, as well as individual prosperity and well-being.”
"EDA is proud to partner with this year's 'Build to Scale' grantees as they invest in entrepreneurs and create equitable access to capital in their communities," said Assistant Secretary of Commerce for Economic Development Alejandra Y. Castillo. "These projects will give the next generation of industry-leading companies a seminal boost that will result in job creation and private investment – potentially transforming a regional economy and creating economic opportunity beyond what we can foresee.”
The 2022 Build to Scale program was comprised of two competitions––the Venture Challenge and the Capital Challenge. The Venture Challenge supports programs that enable high-growth technology entrepreneurship and foster inclusive access to proven entrepreneurship support models. The Capital Challenge increases access to capital in communities where risk capital is in short supply by providing operational support for early-stage investment funds, networks, and training programs that focus on both traditional and hybrid equity-based financing.
About the U.S. Economic Development Administration (www.eda.gov)
The mission of the U.S. Economic Development Administration (EDA) is to lead the federal economic development agenda by promoting competitiveness and preparing the nation's regions for growth and success in the worldwide economy. An agency within the U.S. Department of Commerce, EDA invests in communities and supports regional collaboration in order to create jobs for U.S. workers, promote American innovation, and accelerate long-term sustainable economic growth.