WUHAN,
China, June 24, 2024 /PRNewswire/ -- On
June 20 (UTC-4), the U.S. Food
and Drug Administration (FDA) approved the IND application for
NouvNeu001, a cell therapy product from iRegene therapeutics
targeting Parkinson's Disease. This marks a significant milestone
as NouvNeu001 becomes the world's first chemically induced
allogeneic cell therapy product to enter clinical stages for
Parkinson's disease in the US. Previously, the "Combined Phase I/II
Clinical Study" of NouvNeu001 had already received approval from
China NMPA in August 2023 and
demonstrated positive safety and efficacy data in its Phase I
trials. On June 20, 2024, iRegene
further announced IND approval of NouvNeu001 by the U.S. FDA for
the treatment of mid-to-late stage of Parkinson's disease.
Notably, in March 2024, iRegene
was granted the exemption from the FDA, highlighting the
recognition of iRegene's pioneering platform and innovative
production and quality systems.
Dr. Cai Meng, the CMO of iRegene,
emphasized that obtaining the exemption from the FDA, followed by
the IND approval for NouvNeu001, underscores iRegene's
professionalism in developing innovative chemically induction
platform. This milestone also paves the way for subsequent
international operations of iRegene.
iRegene is among the early biotech companies globally to apply
"AI + chemical induction" for the specific functional modification
of cells. This platform offers significant advantages, including
higher efficiency, safety, cost-effectiveness, and suitability for
large-scale industrial production. Leveraging this unique platform,
iRegene has developed a robust pipeline of universal iPSC derived
cell products aimed at treating "incurable" diseases such as
neurodegenerative disorders, including Parkinson's disease and
blindness. Due to the originality of iRegene's technological
platform and the strong advantages demonstrated in product
development, the FDA granted a special exemption for iRegene's
groundbreaking product in March
2024.
In early 2024, clinical trials for NouvNeu001 were successfully
initiated at Beijing Hospital and Zhongnan Hospital of Wuhan University in China. By integrating the advantageous
clinical resources of neurosurgery, neurology, and other
departments, a systematic evaluation of the safety, tolerability,
and efficacy of stereotactic bilateral intracerebral injections of
NouvNeu001 for mid-to-late stage Parkinson's disease is being
conducted. The clinical project is currently in its acceleration
stage. Preliminary results from the ongoing multicenter clinical
study have indicated that the patients received NouvNeu001 showed
consistently significant improvements in MDS-UPDRS Part III (motor)
scores, and good safety with no cell product related adverse
effects.
Following the significant progress of the NouvNeu001 clinical
trial and the preliminary positive efficacy and safety data,
iRegene will soon commence patient recruitment for the clinical
trial of its early-onset Parkinson's disease product, NouvNeu003,
which was also approved by China NMPA in December 2023.
Beyond neurodegenerative diseases, iRegene continues to explore
other "incurable" diseases. On March of this year, iRegene's
breakthrough ophthalmic product, NouvSight001, was granted Orphan
Drug Designation (ODD) by the FDA. This product targets retinal
diseases and is a first of its kind induced pluripotent stem cell
(iPSC)-derived ophthalmic allogeneic cell therapy developed by
iRegene's team also from company's unique "AI+ chemical induction"
platform.
Dr. Wei Jun, CEO of iRegene,
highlighted that the team's efforts in maintaining rigorous
standards of innovative products while ensuring steady progress in
R&D. The project advancement plan previously set by iRegene is
scheduled to the "week", laying an indispensable foundation for the
timely clinical entry of core pipelines. "On the basis of cautious
and robust R&D efforts, iRegene aims to leverage its innovative
technologies to bring breakthroughs for a multitude of currently
incurable diseases, bringing hope to patients and families deeply
affected by these conditions. Dual approval of IND applications of
NouvNeu001 by the U.S. FDA and China NMPA further boosts the
confidence of iRegene's global team in building a world-class
innovative platform," said Dr. Wei
Jun.
About NouvNeu001
NouvNeu001 is a chemically induced human dopaminergic neuron
precursor derived from iPSC, with iRegene Therapeutics wholly owned
proprietary. NouvNeu001 is the world's first iPSC-derived and
chemically induced allogeneic cell therapy product for clinical
application. On August 2, 2023, the National Medical Products
Administration (NMPA) of China officially approved the
Phase I/II clinical trial of NouvNeu001, designed to assess the
safety, tolerability and efficacy in treating mid-to-late
Parkinson's disease. The clinical trial commenced successfully
in January 2024 at Beijing Hospital. More information
about this trial is available at clinicaltrials.gov (NCT#06167681).
Furthermore, the clinical trial application was approved by FDA on
20th, June, 2024.
About iRegene Therapeutics
iRegene Therapeutics is the earliest biotech company in the
world focusing on accurately reprograming cell fate and functions
by chemicals. Leveraging its unique "AI + chemical induction"
platform, iRegene Therapeutics has developed extensive pipelines of
universal iPSC-derived cell products. The company is dedicated to
advancing universal cell therapy products and introducing novel
cell replacement therapy for "incurable" neurodegenerative
diseases, including Parkinson's disease and retinal diseases.
View original
content:https://www.prnewswire.com/news-releases/iregene-receives-ind-approval-from-us-fda-to-start-clinical-trial-for-parkinsons-disease-302180135.html
SOURCE iRegene Therapeutics Co., Ltd