NeuroScientific Biopharmaceuticals has described FY22 as a landmark year, after it achieved an historic milestone by starting the clinical development program for its lead drug EmtinBTM.

Neuroscientific Biopharmaceuticals (ASX:NSB) has reported its FY22 results in a year which saw it become known as a clinical-stage drug development company, after it was able to start the clinical development program for EmtinBTM.

NSB believes the trademarked peptide-based compound will become a key treatment therapy for neurodegenerative conditions like Multiple Sclerosis (MS) and Azheimer’s disease.

In the world of biomedical science, achieving the landmark outcome involved NSB completing several important development milestones for EmtinBTM, including:

  • Successful finalisation of the preclinical safety and toxicology program
  • Manufacturing of clinical-grade EmtinBTM
  • HREC approval to start the Early-Phase Clinical Trial.

Recruitment of first participant

Since becoming a clinical-stage drug development company, NSB has completed a major clinical milestone of first participant recruited for the Early-Phase Clinical Trial.

Additionally, the company has submitted its application for a Phase I Clinical Trial for HREC approval.

Achieving HREC approval for the Phase I Clinical Trial will signal completion of another major milestone for NSB.

Progress in MS R&D

NSB advanced its MS R&D program throughout FY22. During the 1H FY22, NSB partnered with Canadian contract research companies BioSpective and Imeka to support development of EmtinBTM as a potential disease modifying drug for MS.

BioSpective was engaged to undertake animal studies at its facilities, while Imeka prepared its recently- developed powerful diffusion MRI imaging technology to be incorporated into NSB’s animal studies and future clinical studies in patients.

Preclinical biomarker studies were undertaken to investigate the effect of EmtinBTM on dysfunctional inflammatory responses associated with MS.

Initial outcomes demonstrated that EmtinBTM significantly reduced important MS-related biomarkers Interferon-gamma-inducible protein-10 (CXCL10/IP-10), Matrix Metalloproteinase-9 (MMP-9), Immunoglobulin G (IgG), and decreased Th1-mediated cell proliferation.

These results were the first indicative data that EmtinBTM  potentially modulates immune responses outside of the brain (peripheral immune responses).

Follow up biomarker studies during the 2H FY22 confirmed the result with EmtinBTM found to significantly reduce key drivers of chronic inflammation and autoimmune diseases, interleukins (IL)-17A, IL-17F. and IL-6.

Armed with impressive inflammatory biomarker outcomes, the MS R&D program progressed to proof of efficacy animal studies, conducted by BioSpective in industry gold-standard models of MS, during H2 FY22.

In June 2022, NSB reported highly promising preliminary results in the myelin oligodendrocyte glycoprotein-induced experimental autoimmune encephalomyelitis (MOG-EAE) mouse model.

The results informed selection of the most effective doses (10mg/kg and 20mg/kg) for further validation in a larger study to be completed during H1 FY23. 

Ophthalmology R&D Program

Throughout FY22, the core focus of ophthalmology R&D involved preclinical safety and toxicology studies to support advancing EmtinBTM into clinical development for ocular indications, such as glaucoma.

The company completed several pivotal studies, including a four-week ocular safety and tolerance study in non-human primates (NHPs) involving weekly ocular administrations of EmtinBTM, and a 13-week Ocular Toxicity study.

Both studies assessed multiple doses of EmtinBTM  up to three times the estimated effective dose in humans and were undertaken in the leading gold-standard model for ocular toxicity.

The ocular safety and tolerance study reported no evidence of abnormal adverse effects associated with EmtinBTM.

The safety outcomes from the 13-week Ocular Toxicity study will be reported during the H1 FY23. It will be a major de-risking for its ophthalmology R&D program due to it being the longest to be undertaken by NSB to date in assessing ocular safety of EmtinBTM.

R&D expenditure higher

The financial results for FY2022 reflect the costs of continued advancement of EmtinBTM

NSB reported a net after-tax loss FY22 of ~$10.45 million compared with ~3.18 million in FY21.

Research and development expenditure was significantly higher during the period at ~$7.2 million compared to ~$2.22 million in FY21,  predominantly driven by preclinical studies and manufacturing activities to support the commencement of clinical trials.

On June 30, 2022 NSB had a cash and cash equivalents balance of $7,216,048  compared with $14,162,247 pcp and Net Assets of $7,737,335 compared with $14,827,443 pcp.

New director of clinical development

NSB also expanded its clinical leadership team to include the appointment of Simon Scott as director of clinical development, to capitalise on his 15-plus years of clinical research experience, including senior management stints with Linear Clinical Research in Perth.

Clinical ophthalmologist Dr Peter Hnik and ex-Sanofi toxicologist Dr Frank Bonner were both appointed to its scientific advisory team, bringing considerable drug development experience to NSB.

The company said the outlook for FY23 is very promising with outcomes of several clinical trials due to be reported in the near future.

This article was developed in collaboration with NeuroScientific Biopharmaceuticals,  a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.