OXFORD, UK / ACCESSWIRE / April 12, 2023 / IntraBio Inc announced it completed and closed its $15 Million Series C funding round on April 5, 2023.
The company is on track to complete its Phase III Pivotal trial with IB1001 for Niemann-Pick disease type C (NPC) in mid-June 2023. Data is planned to be available by the end of June 2023.
IntraBio is developing other assets-its IB2000, IB3000, IB4000, and IB5000 series.
Series C Funding Round Completed and Closed April 5th, 2023
IntraBio, a late-stage biopharmaceutical company dedicated to finding treatments for rare and common neurodegenerative diseases, has successfully completed a $15 million Series C funding round.
"We are pleased to have completed this funding round and look forward to sharing the results of our Pivotal IB1001-301 trial with the patient community and our shareholders," said IntraBio Chairman Mallory Factor. "We are confident in the potential of our treatments to make a significant difference in the lives of those affected by these rare and devastating diseases."
The funds will be used to support the company's ongoing Phase III Pivotal trial (IB1001-301) with IB1001 (N-acetyl-L-leucine), and to prepare IB1001 for US New Drug Application (NDA) and European Marketing Authorization Application (MAA) for NPC.
The IB1001-301 NPC trial and marketing applications are further supported by two successful Phase IIb studies with IB1001 for NPC and GM2 Gangliosidoses (GM2), which are peer-reviewed and published [Bremova et al. 2022; Martakis et al. 2023].
IntraBio management has been actively exploring alternatives for maximizing shareholder value with investment banks, pharmaceutical companies, investment funds, and other financial community members.
Pivotal IB1001 Clinical Trial for NPC (IB1001-301)
IB1001-301 investigates IB1001 for both the symptomatic and long-term neuroprotective effects of the treatment of NPC.
Patients were screened across 13 multinational trial sites in Australia, Europe, and the US. Given the NPC community's extremely high interest in IB1001-301 and their high unmet medical need, IntraBio enrolled 130% of target patients for the trial in under three months, substantially increasing the power of the study.
Data from the IB1001-301 clinical trial is expected by the end of June 2023.
Further information on the IB1001-301 trial can be found via ClinicalTrials.gov (NCT05163288).
Near-Term Marketing Authorization
A successful IB1001-301 trial enables an accelerated marketing application and approvals for IB1001 for NPC by both the US Food and Drug Administration (FDA) and the European Medicine Agency (EMA). The IB1001-301 NPC trial applications are further supported by two successful Phase IIb studies with IB1001 for NPC (NCT03759639) and GM2 Gangliosidosis (GM2; NCT03759665).
IB1001 has been granted Fast Track Designation for NPC and GM2 by the FDA, which expedites the review of a new drug application and potential approval. IntraBio has already commenced the filing preparations to ensure that the NPC NDA/MAA can be submitted expeditiously when the data is available.
Upon approval of IB1001, IntraBio would be eligible for a "Priority Review Voucher" by the FDA, which can be used or sold. The value of the sale of these vouchers from comparable transactions in the past two years was over $100 million each.
Intellectual Property Protections & Market Exclusivity
IntraBio has robust, multi-tiered market protections that safeguard IB1001 through 2039, including 14 Patent Families granted/applied for in over 60 countries (including 23 jurisdictions), 13 Orphan Drug Designations (in the US/ EU), and new chemical entity status granted at the time of Marketing Authorization.
Label-Expansion Opportunities
IntraBio is committed to getting IB1001 to market as quickly as possible to help address patients' high unmet medical needs. Following the initial approval of IB1001 for NPC, there is a range of de-risked label expansion opportunities for IB1001. IB1001 is Phase III ready for other disease indications, including GM1 Gangliosidosis, GM2 Gangliosidosis, and Ataxia-Telangiectasia.
In addition, with its collaborators, IntraBio has evaluated the effect of the IB1000 series in compassionate-use studies in over 250 patients successfully in over 12 other disorders. These clinical studies show the potential and form part of the scientific basis for trialling other indications for additional approvals.
Other successful clinical studies include Parkinsonism, Lewy Body Dementia (LBD), Restless Legs Syndrome (RLS), Amyotrophic Lateral Sclerosis (ALS), and Multiple Sclerosis (MS).
Other Drug Series
IntraBio continues to focus on the development and approval of IB1001 while making significant progress in developing a robust pipeline of compounds (including IB2000s, IB3000s, IB4000s, and IB5000s series) and securing their Intellectual Property protections.
Patents have been issued for the IB5000 series in the US, with the European Patent Office granting "Intention to Issue" in 38 jurisdictions, including the EU.
About IntraBio
IntraBio Inc is a biopharmaceutical company with a late-stage drug pipeline, including novel treatments for common and rare neurodegenerative diseases. IntraBio's platform technologies result from decades of research and investment at premier universities and institutions worldwide. Its clinical programs leverage the expertise in lysosomal function and intracellular calcium signalling of its scientific founders from the University of Oxford and the University of Munich.
IntraBio's management team and consultants have a successful track record of drug development and commercialization in the USA and Europe. This team translates innovative scientific research in the fields of lysosomal biology, autophagy, and neurology into novel drugs for a broad spectrum of genetic and neurodegenerative diseases to significantly improve patients' lives.
IntraBio Inc is a US corporation with its principal operations in Oxford, United Kingdom.
For further information, please contact:
Cass Fields
Vice-President of External Affairs
Email: [email protected]
SOURCE: IntraBio.com