Dimerix's drug granted QYTOVRA as brand name by US FDA. Picture Getty
Health & Biotech
Dimerix (ASX:DXB) jumped 6% this morning after announcing the US FDA has granted conditional approval for commercial brand name, QYTOVRA, to be used for lead drug candidate, DMX-200.
QYTOVRA, pronounced as kai-toe-vra, treats focal segmental glomerulosclerosis (FSGS) disease.
The trademark for QYTOVRA has also been accepted and registered in Europe, UK, Australia, China, Japan, and the South Korea.
Dimerix explained that it is a regulatory requirement in the US that pharma companies submit new proprietary name applications to the FDA after certain clinical trials are conducted.
These brand names must be reviewed and approved by the FDA before the drug can be marketed and sold in the US. This process can often take at least 12 months, followed by a six-month FDA review.
The FDA evaluates whether the proposed drug name looks like or sounds like any other pending or approved names, which also includes handwriting and dialect tests, as well as reviews of reports of medication error data.
The ongoing Phase 3 trial of QYTOVRA (DMX-200) has now surpassed its first 72 patients, and will move towards the outcome of Part 1 analysis in March 2024.
“In parallel, we continue to engage with the FDA, EMA and NMPA as well as prospective marketing partners,” said Dr Nina Webster, CEO of Dimerix.
Starpharma (ASX:SPL) has completed recruitment for the post-market clinical study of its antiviral barrier nasal spray, VIRALEZE, in the UK.
Recruitment proceeded rapidly and the study has now successfully enrolled around 200 patients with laboratory-confirmed Covid-19.
The randomised, double-blinded, placebo-controlled clinical study of VIRALEZE will assess SARS-CoV-2 viral load in the nasal cavity of patients while using VIRALEZE.
The primary endpoint is the level of a patient’s viral load over a seven-day treatment period.
The study is also collecting additional information on the ability of VIRALEZE to prevent disease progression and worsening of symptoms, and shorten the duration of symptoms in patients with Covid-19.
VIRALEZE works by creating a barrier within the nasal cavity to physically trap and block cold/respiratory viruses. The spray forms a physical moisture barrier between viruses and the nasal mucous membrane that traps and blocks viruses.
Meanwhile,Invion (ASX:IVX) says it will add South Korea to its list of exclusive territories for the Photosoft technology in the treatment of all cancer types.
The company will make a contribution payment of $900K towards the development costs of Photosoft to the technology licensor, RMW Cho Group, in exchange for the new territory.
South Korea has a lucrative and growing oncology market that is expanding at 12.6% CAGR, and is expected to reach US$7.4 billion by 2030.
Invion says this new agreement comes at a key juncture as Invion prepares to start human trials following promising results from its preclinical studies of Photosoft.
In those earlier studies, Photosoft is shown to regress cancers, stimulate an immune response, and impede the spread of cancers.
At Stockhead we tell it like it is. While Dimerix is a Stockhead advertiser, it did not sponsor this article.
Health & Biotech
Health & Biotech
Health & Biotech
