ASX Health Stocks: MGC Pharma passes final hurdle before FDA submission; patents for Recce and AdAlta
Health & Biotech
Health & Biotech
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MGC Pharma (ASX:MXC) has completed the full pre-clinical rodents study for CimetrA, an anti- inflammatory and immunomodulatory agent for viruses like Covid-19.
The study done in Israel was designed to determine toxicological effects of CimetrA in rats over a 14-day period, followed by a 7-day review period.
It involves four study groups, three separate dosage groups, and one control group, with histopathology tests conducted on all organs per FDA guidelines.
No anomalies were observed in the biopsies taken, nor were any clinical or behavioural adverse events recorded.
This was a crucial study in the regulatory approval process for Investigational New Drugs (IND) approval by the FDA.
There is a strict process for FDA approval: discovery, preclinical development, and clinical trial, where the boundary between preclinical development and clinical trial is sharply defined by the IND approval.
Final FDA approvals will ensure that CimetrA meets the criteria for further clinical study and commercialisation of CimetrA in the US.
“The successful completion of this study and the excellent results attained is an important milestone moment for the company, as we continue to progress CimetrA along the mandated clinical pathway,” said CEO Roby Zomer.
“The results of this study are a critical step in advancing MGC’s submission to the FDA, and for the final approval of CimetrA as an Investigational New Drug in the US.”
Recce Pharma (ASX:RCE) says the Australian Patent Office has issued notification of intent to grant Recce’s Patent Family 3 “Anti-Virus Agent and Method for Treatment of Viral Infection”.
The patent relates to the company’s RECCE 327 and Anti-Viral formulation RECCE 529.
Specifically, the patent covers the composition and method of manufacture of RECCE anti-infectives.
It also covers the use of the two drugs in treating viruses having a lipid envelope or coat, examples being SARS-CoV-2 and Corona viruses, Influenza viruses, HIV, Hepatitis, Ross River and Herpes viruses.
This is the final patent of Family 3 (expiring in November 2037), following those already granted in markets such as China, Japan, Europe and Hong Kong.
“Receiving notice that this Australian patent application will proceed to grant is another milestone in the company’s global IP strategy,” said CEO James Graham.
“We are thrilled by the yet further validation to the potential importance of our infectious disease compounds.”
Meanwhile, AdAlta (ASX:1AD) announced that a second Japanese patent relating to lead program, AD-214, has been granted by the Japanese Patent Office.
The patent is for polypeptides containing the binding loops of the company’s lead i- body AD-214 that have variation in the i-body scaffold sequence.
The patent coverage also extends to i-bodies that are related to AD-214 for treating CXCR4-related diseases or disorders.
Japan is the third largest pharmaceutical market in the world and remains important to AdAlta’s partnering and commercialisation strategy.
“This patent is a valuable, additional piece of intellectual property which enables expansion of protected claims for AD-214 in Japan, a major market for fibrosis-related diseases,” said AdAlta CEO, Dr Tim Oldham.