Nacuity Pharmaceuticals Announces First Patients Implanted in Final Cohort of Phase 1/2 Clinical Trial Evaluating NPI-002 Intravitreal Implant for the Delay of Cataract Progression
April 30 2024 - 9:00AM
Nacuity Pharmaceuticals, Inc., a clinical stage biopharmaceutical
company developing treatments for retinitis pigmentosa, cataracts
and other ocular diseases caused by oxidative stress, today
announced that the first patients have been implanted in the final
cohort of the Phase 1/2 clinical trial evaluating NPI-002 for
delayed cataract progression in patients undergoing vitrectomy. An
independent Data Safety Monitoring Board (DSMB) recommended
proceeding with the final cohort after a positive safety review,
which was subsequently approved by the overseeing Human Research
Ethics Committee.
NPI-002 is a proprietary antioxidant molecule delivered via a
sustained release intravitreal implant. The Phase 1/2 NP-2 trial is
a randomized, controlled, masked clinical trial assessing the
safety and efficacy of NPI-002 in delaying cataract progression in
adult patients undergoing vitrectomy.
“Patients typically need cataract surgery within a year of their
vitrectomy,” said Robert Casson, MBBS (Hons), DPhil, principal
investigator of the trial and Professor, Royal Adelaide Hospital.
“Delaying a subsequent cataract surgery after vitrectomy can
alleviate the stress of having two ocular surgeries in a short
period of time and improve surgical outcomes for patients.”
The final cohort of the trial is actively enrolling patients for
clinical sites at The Royal Adelaide Hospital (RAH) in Adelaide,
South Australia, and personalEYES in Parramatta, New South Wales,
Australia.
“We’re encouraged by the positive safety signals seen to date
and we’re grateful for the trial’s progression thanks to the
diligent work of the trial investigators and the participation of
patients,” said Halden Conner, Chairman, CEO, and Co-Founder of
Nacuity Pharmaceuticals. “We look forward to continuing our
evaluation of our NPI-002 antioxidant to slow cataract progression
and preserve the sight of these patients.”
For more information about the Phase 1/2 clinical trial of
NPI-002, please visit clinicaltrials.gov (Identifier:
NCT05026632).
About NPI-002NPI-002 is a novel,
differentiated, slow-release, small molecule being developed to
slow cataract progression. For the treatment of cataract, a sterile
intravitreal implant containing NPI-002 has been developed, along
with a precision delivery system. In vitro and in
vivo studies showed vitreal elution over time and revealed no
cytotoxicity with NPI-002. In ex-vivo rat and porcine
lenses, NPI-002 inhibited oxidative-induced cataracts. NPI-002 is
currently being evaluated in a Phase 1/2 proof-of-concept clinical
trial in Australia (NCT05026632).
About Nacuity PharmaceuticalsNacuity
Pharmaceuticals is a clinical-stage leader in innovative treatments
for oxidative stress. The company’s powerful, targeted therapies
aim to attenuate 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, cataract and inherited cystinosis. 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 (https://www.fightingblindness.org/)
and its venture arm RD Fund
(https://www.retinaldegenerationfund.org). For more information,
please visit www.nacuity.com.
Media ContactJulia
Clements267.626.1085jclements@6degreespr.com