Great work @silsol,
I knew it was a biological drug trial that PIQ were contracted for analysis in a clinical trial, but not that it was a biosimilar for Omalizumab a MAB that is also now PBS listed in Australia for severe asthma in eligible patients (very restricted, as a high cost drug), and also used a lot for chronic spontaneous urticaria & also some more rare immunological diseases (spontaneous anaphylaxis, mastocytosis & others). It’s an absolute life changer for many patients & safe.
Looks like they have hit the patent cliff with that drug (Big Pharma), so if this trial is successful it may make the drug more affordable, if it can replicate Omalizumab with the same safety.
Patients are lucky in Australia it’s only the cost of the script on special access or PBS, not around $900, & for severe asthma that’s every 2 weeks & CSU monthly. Some patients are on much higher doses than 300mg.
There are newer MABs in development all the time & a fight to have them approved for PBS for patients that truly need them.
That is pretty prestigious & amazing that PIQ have been awarded that contract for drug development in a biological to go head to head with Xolair (Omalizumab), a multi billion dollar market globally.
Mepolizumab (for severe eosinophilic asthma) is another biological with a patent cliff in the next few years, & is also very safe. Cytokine pathways such as IL-5 which this biological also blocks, stops the IgE (inflammatory response) in patients also, & improving symptoms of severe asthma.
Previously Drs relied heavily on corticosteroids for some patients who are dependent at low dose & others for acute exacerbations at high dose. They are nasty drugs with long term side effects, as well as short term.
PIQ lab credentials are all telling (thanks again for your post). It’s not just their tests (at commercial stage, but also in development; endometriosis biomarkers will be a massive blessing too) & income from the lab from clinical trials etc.
If a successful trial for Biosana Pharma, I think this will spark more interest in highly specialised biological drug development & trial analysis globally. MABs are being trialled & approved for a lot of indications currently (Immunology/Respiratory, Rheumatology, Cancer, trials in other diseases also).
They are all high cost drugs & if the medical community can just write a script for patients suffering terribly, without all the restrictions, then bring it on.
GLTAH.
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