Drug development company NeuroScientific Biopharmaceuticals Ltd (ASX: NSB) is not ready to give up on EmtinB, its trademark drug that didn’t make it past the Human Research Ethics Committee (HREC) and resulted in the Company’s previous CEO resigning. Remaining undeterred, it has filed a new patent, entitled “Neuroprotective compositions and methods”, that will use a combination of drugs to help people with multiple sclerosis.
Initially, the Company burnt a lot of cash—over $13 million in two years—to develop EmtinB, a peptide-based compound, to aid Aussie Alzheimer’s and glaucoma patients. However, NeuroScientific wasn’t even able to get it to Phase 1 human trials due to less than satisfactory proof of benefits. Did that compel NeuroScientific to shelve its goals for EmtinB? Nope.
On the contrary, it conducted an in vitro study, together with Teva’s Copaxone, using cultured rat cortical neurons to evaluate the effect of treatments on neuron survival, neurite length and area of the myelin sheath, all of which are critical mechanisms involved in Multiple Sclerosis (MS).
Globally, up to three million live with MS. In the US alone, 400,000 people have multiple sclerosis. MS is a chronic, incurable central nervous system disease wherein the damaged neurons affect the brain, spinal cord and immune system. Due to inflammation, the protective coating around nerve cells (aka neurons) disappears, leaving organs vulnerable. NSB aims to use its combination of drugs to boost neuron survival and recover the myelin sheath, i.e. the protective layering around it.
Two dose levels of EmtinB alone, two dose levels of Copaxone (a prescription med for MS) alone and two different combinations of EmtinB + Copaxone were evaluated.
Israeli pharma company Teva introduced Copaxone in the mid-1990s to treat multiple sclerosis. Developed by a team of researchers at the Weizmann Institute of Science in Israel, it quickly became the best treatment the world had to offer for the disease. Copaxone got the United States Food and Drug Authority (F.D.A.) approval in 1996. However, lately, the drug’s sales have been declining in light of generics cropping up. In 2022, Teva forecasts that Copaxone will bring in about $850 million, falling from about $1 billion in 2021 sales. This partnership can make it a win-win for both companies.
NeuroScientific’s study revealed that the co-treatment of EmtinB and Copaxone notably promotes neurite length, cortical neuron survival and myelin sheath formation around cortical neurons in concert. This effect seems to be synergistic since the combination of EmtinB at 50µg/mL and Copaxone at 3µg/mL gives a statistically significant impact in all three areas. This three-pronged effect is not observed when either drug is tried on its own. This data suggest that EmtinB may provide additional therapeutic benefits to Copaxone.
By teaming up with Teva, NeuroScientific is boosting its odds of regaining investor trust after the HREC fiasco. Moreover, since its CEO’s resignation, the Company has brought on Dr Jurgen Lindner as a consultant. He has a PhD in neurosciences and has extensive experience in drug development and the manufacture of therapeutic products. He will be overseeing the development of this new patent.
The HREC rejection revealed that NeuroScientific had primarily failed on three fronts: safety (local injection site tolerability was not satisfactorily demonstrated), purity of EmtinB, and efficacy (the Company tried to get away with using a different form of EmtinB in the study than its planned clinical product).
Having learnt its lessons and upgraded its board, NeuroScientific plans on undertaking phase I human trials for the new combination drugs. Plus, it plans on launching one more patent with EmtinB soon.
Will it be able to get HREC’s approval this time round?
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