NPI-001

REYKJAVIK, Iceland and FORT WORTH, Texas, March 12, 2024 (GLOBE NEWSWIRE) -- Arctic Therapeutics ehf, an Icelandic drug development company and partner Nacuity Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing treatments for retinitis pigmentosa, cataracts and other diseases caused by oxidative stress, today announced approval by the European Medicines Agency (EMA) for initiation of the first clinical trial evaluating AT-001 (Nacuity’s NPI-001) for the treatment of Hereditary Cystatin C Amyloid Angiopathy (HCCAA) in Iceland. HCCAA is an ultra rare, serious condition characterized by the accumulation of amyloid in the brain's blood vessels, which can lead to cerebral hemorrhage, stroke, and progressive neurological deterioration, including dementia. Current treatment options are severely limited, focusing primarily on symptom management rather than addressing the underlying cause of the disease. AT-001 is a differentiated, purified, prescription-quality, GMP-grade N-acetylcysteine amide (NACA). “EMA's approval paves the way for a comprehensive investigation into the safety and efficacy of a novel therapeutic approach designed to halt or reverse the progression of HCCAA. Our study aims to explore the potential of AT-001 in modifying the disease's course, improving patient outcomes, and ultimately, saving lives,” said Ivar Hakonarson, CEO and co-founder of Arctic. In September 2022, Nacuity and Arctic entered into an exclusive licensing agreement and strategic partnership for the development and commercialization of Nacuity’s NPI-001 under the name AT-001 for HCCAA in Iceland and related forms of amyloid angiopathies (CAAs) worldwide. Nacuity is also currently evaluating NPI-001 in Phase 1/2 clinical trials in Australia for retinitis pigmentosa associated with Usher syndrome and cystinosis. “Our proprietary NPI-001 has potential to address the myriad diseases and conditions where oxidative stress plays a role. EMA approval for the evaluation of NPI-001 tablets for treatment of HCCAA represents most importantly, a step forward in addressing HCCAA, a life threatening and underserved rare disease, and secondly, a key pharmaceutical quality milestone for the companies in the global development of NPI-001,” said G. Michael Wall, Ph.D., SVP & CSO, Nacuity. About Nacuity Pharmaceuticals, Inc. Nacuity Pharmaceuticals, Inc. ( ), is a clinical-stage leader in innovative treatments for oxidative stress. The company’s powerful, targeted therapies aim to attentuate oxidative tissue damage, a driver of blinding eye diseases and a broad spectrum of serious chronic conditions. Nacuity has three highly differentiated clinical programs ongoing in retinitis pigmentosa, cataracts and cystinosis with the potential to be first-of-a-kind therapies and gateways to wider applications. Nacuity has operations in Fort Worth, TX, USA, and Australia, and extensive managerial and scientific domain expertise as well as backing from Foundation Fighting Blindness ( ) and its venture arm RD Fund ( ). About Arctic Therapeutics ehf Arctic Therapeutics ehf (AT) ( ) is an Icelandic drug development company, established in 2015 as a spin-off from the US-based Center for Applied Genomics (CAG), a research center at the Children's Hospital of Philadelphia. AT leverages the transformative power of applied genomics, steering the course of drug development towards safer, more effective treatments for some of the world’s most challenging diseases. The company has operations in Iceland, USA, and multiple collaborations across Europe. Nacuity Media Contact Julia Clements Tel: 267.626.1085 jclements@6degreespr.com Arctic Media Contact Gulli Arnason gulli@arctictherapeutics.com

Capsulyte PREGAME, a doctor formulated supplement to aid alcohol recovery, launches at DC Fashion Week as the hangover recovery market is set to grow over the next decade. CRANBURY, N.J., Feb. 16, 2024 /PRNewswire/ -- Capitalizing on cutting-edge ingredients, Capsulyte's PREGAME has emerged as the most advanced product to aid in party recovery and address symptoms often associated with hangovers. As a significant milestone for the brand, Capsulyte has been invited to participate in the prestigious DC Fashion Week, a testament to the company's alignment with premium lifestyles and the fashion industry's elite. This invitation further underscores Capsulyte's commitment to excellence and positions PREGAME as the preferred choice for discerning individuals seeking to enjoy social occasions to the fullest, without the next-day regrets. Many individuals face the unpleasant reality of hangover symptoms such as headaches, fatigue, and nausea, resulting from alcohol consumption. These effects can be primarily attributed to acetaldehyde, a toxic compound that is created when the liver metabolizes alcohol. According to Persistence Market Research, the global hangover recovery market is estimated to reach $4.2 billion by the year 2030. PREGAME is uniquely situated to help solve the issue of acetaldehyde accumulation among individuals who want to live healthy, balanced lives while also maintaining their productivity. PREGAME addresses the challenge of party recovery head-on with a formulation enriched with the scientifically backed ingredients Siliphos® and Clovinol® to support liver detoxification, overall liver health, and acetaldehyde metabolism. Siliphos®, a patented botanical derivative from milk thistle, has been clinically shown to improve liver function, inhibit fibrotic cells, and shield against oxidative stress. Its unique Phytosome technology enhances the bioavailability of silybin, a key component for liver health that is otherwise poorly absorbed by the body. This innovative approach ensures marked improvement over standard milk thistle extracts, offering comprehensive liver protection and recovery. Clovinol®, sourced from the potent spice clove, is distinguished by its capacity to increase the potent antioxidant, glutathione. It's also a robust liver protector that accelerates the elimination of acetaldehyde from the body up to 2.5 times faster than usual, thereby reducing alcohol's negative effects and the severity of symptoms associated with hangovers. With the synergy of Siliphos® and Clovinol®, combined with Dihydromyricetin (DHM) and N-Acetyl Cysteine (NAC), PREGAME represents the pinnacle of a doctor-formulated, research-backed solution for those seeking to mitigate the aftereffects of alcohol consumption. As the brand marks its presence at DC Fashion Week, Capsulyte is set to redefine the standards of social indulgence and wellness. Its participation not only highlights the efficacy and luxury associated with PREGAME but also solidifies Capsulyte's stance as a trailblazer in the dietary supplement industry. Unlock the ability to embrace a healthier, more vibrant lifestyle with Capsulyte's PREGAME, where premium care meets unparalleled social experiences. Capsulyte's PREGAME and HYDRATION are available on the store site and Amazon. FDA Disclaimer: The statements made regarding this product have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure or prevent any disease. All information presented here is not meant as a substitute for or alternative to information from healthcare practitioners. Please consult your doctor. The news site hosting this press release is not associated with Capsulyte. It is merely publishing a press release announcement submitted by a company, without any stated or implied endorsement of the product or service. About Capsulyte Capsulyte is a doctor-founded dietary supplement company dedicated to enhancing the health and wellbeing of individuals through scientifically backed, innovative products. Specializing in alcohol and party recovery solutions, Capsulyte is committed to delivering superior quality, efficacy, and safety in every product, supporting people in living their best lives. For more information, visit Press Contact Dan Nguyen 908-292-3110 SOURCE Capsulyte