Nacuity Pharmaceuticals and Arctic Therapeutics Enter Licensing Agreement and Strategic Partnership to Develop NPI-001

Collaboration leverages Nacuity’s NPI-001 for the treatment of fatal rare disease HCCAA in Iceland

FORT WORTH, Texas and REYKJAVIK, Iceland, Sept. 13, 2022 (GLOBE NEWSWIRE) — Nacuity Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing treatments for retinitis pigmentosa, cataracts and other diseases caused by oxidative stress, and Arctic Therapeutics International, a precision-based drug development and diagnostic testing company using genetic and genealogy information to guide therapeutic development, today announced the companies have entered into an exclusive licensing agreement and strategic partnership for the development and commercialization of NPI-001 in Iceland for the treatment of hereditary cystatin C amyloid angiopathy (HCCAA). HCCAA is an inherited, rare amyloid disease primarily seen in the Icelandic population that leads to paralysis, dementia and death in young adults.

NPI-001 is Nacuity’s proprietary, GMP-grade formulation of N-acetylcysteine amide (NACA) being developed for the treatment of a broad range of diseases associated with oxidative stress, including HCCAA, which is caused by a leucine to glutamine variant of human cystatin C (hCC). Clinical and in vitro data utilizing N-acetylcysteine and NACA for the treatment of HCCAA support a strong mechanistic rationale for NPI-001 as a potential effective therapy for the treatment of HCCAA.

“We’re pleased to collaborate with Arctic to advance our proprietary NACA, NPI-001, for the treatment of patients with HCCAA,” said Halden Conner, Chairman, CEO and Co-Founder of Nacuity Pharmaceuticals. “This strategic collaboration will help progress our mission to develop therapies that stop oxidative tissue damage and expand our NPI-001 platform to provide a treatment option for a critically underserved disease.”

“There is currently no approved treatment for HCCAA, a fatal genetic disease originating from a mutation primarily found in Icelanders,” said Ívar Hákonarson, CEO of Arctic Therapeutics. “We look forward to working together with Nacuity to advance the development and commercialization of this potentially life-saving treatment for patients who suffer from HCCAA and other related forms of amyloid angiopathies (CAAs) worldwide.”

Under the terms of the agreement, Nacuity will provide exclusive rights to Arctic to develop and commercialize NPI-001 for HCCAA in Iceland and related CAAs worldwide. Nacuity and Arctic will collaborate on all regulatory approval and development activities related to NPI-001 for the treatment of HCCAA. Other terms of the agreement were not disclosed.

About NP1-001
NPI-001 is a differentiated, purified, prescription-quality, GMP-grade N-acetylcysteine amide (NACA) being developed to treat a broad set of diseases and conditions associated with oxidative stress and reduced glutathione levels. NPI-001 has been granted orphan designation by the U.S. Food and Drug Administration for the treatment of retinitis pigmentosa in Usher Syndrome and is currently being evaluated in a Phase 1/2 clinical trial for Usher Syndrome (NCT04355689).

About Nacuity Pharmaceuticals
Nacuity Pharmaceuticals is a clinical-stage leader in innovative treatments for oxidative stress. The company’s powerful, targeted therapies aim to stop 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. Based in Fort Worth, TX, the company has extensive managerial and scientific domain expertise as well as backing from Foundation Fighting Blindness (https://www.fightingblindness.org) and its venture arm RD Fund (https://www.retinaldegenerationfund.org). For more information, please visit www.nacuity.com.

About Arctic Therapeutics International
Arctic Therapeutics (AT) is a private drug discovery and development company focused on identifying the genetic underpinnings of both rare and common diseases and developing them into novel and innovative therapies with highest precision. AT has five programs with wide range of applications with AT-001 (NPI-001) being the company’s lead program. AT has operations in Iceland, USA and multiple collaborative efforts throughout Europe. For more information, please visit https://www.arctictherapeutics.com. 

Nacuity Media Contact
Julia Clements
267.626.1085
jclements@6degreespr.com 

Arctic Media Contact
Hugrún Heimisdóttir
Tel: +354 8613176 
hugrun@arctictherapeutics.com