Nacuity Pharmaceuticals.

The challenge

Nacuity approached Acclime in 2017 with a plan to enter the Australian market to conduct clinical trial activities. Their goal was to undertake a Phase 1 clinical trial of NPI-001, a promising drug designed to slow vision loss by protecting retinal cells from oxidative stress.

Our solution

Acclime’s on-the-ground experts and full range of corporate services enabled Nacuity to successfully advance into the Australian R&D market and join a thriving bioscience ecosystem, as well as develop a strategy for accessing the Australian government’s R&D Tax Incentive program.

The Acclime solution allowed Nacuity to advance its clinical trial program, whilst also:

• Forming valuable connections with key people across the clinical trial ecosystem
• Establishing a network of advisors and world-class experts in the field of ophthalmology in Australia
• Gaining experience and confidence in the US FDA’s acceptance of Australian clinical trial data
• Discovering a high-quality Australian manufacturing partner to save both time and money, and
• Partnering with a highly skilled Australian packaging and distribution firm.

Nacuity was pleased by the opportunities that Acclime opened up for them in the Australian market. They discovered that the Australian clinical trial ecosystem was more highly evolved and much broader than they had anticipated.

The result

The results of Nacuity’s Phase I safety trial of NPI-001 were successful and they began a Phase I/II trial in Usher patients in four capital-city locations in Australia which is ongoing and almost fully recruited. They then began a Phase I/II trial for an anti-cataract agent called NPI-002 in 2022 at the Royal Adelaide Hospital. They also made the decision to move many of the support services for their clinical trial programs in both the USA and Iceland to Australia. Nacuity’s Australian partners are now engaged to handle manufacturing, packaging and distribution for the company.

Acclime’s on-the-ground experience and full range of corporate services enabled Nacuity to successfully advance into the Australian R&D market

Acclime’s work on the Nacuity clinical trial project helped the client achieve:

• More than 12 months saved in both time and costs
• R&D tax incentive benefits
• Access to leading expertise across all aspects of R&D, manufacturing, packaging and distribution

Nacuity is presently planning new trials for additional ophthalmological and neurological conditions in Australia, the US, Iceland and other locations all supported by Australian based companies.

About Nacuity Pharmaceuticals

Nacuity Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company based in Texas, USA. Their mission is to develop a breakthrough treatment for retinitis pigmentosa (RP) – a retinal disease that causes blindness and affects more than 2 million people around the world, a treatment for slowing the progression of cataracts in post vitrectomy patients and breakthrough treatments for several serious neurological disorders.

Acclime’s support allowed Nacuity to establish a strong presence for conducting R&D activities in Australia, and further developing their global R&D program from Australia. Acclime handled all the registrations required to form an R&D entity in Australia, access the tax incentives available, and develop strong networks in R&D, manufacturing, packaging and distribution.