RE: New report from Stanford CP8 Mar 2023 20:31
lets not forget what we are up against''
only one lupus drug has been given approval in the past 50-60 years - Benlysta from Glaxo. However, Benlysta only just scraped through clinical trials and the FDA and has many key failings. (a) Benlysta failed to be approved by NICE for several years and the German regulators and only passed 13:2 at the FDA; (b) showed slim efficacy at 52 weeks and did not show efficacy at 76 weeks missing its secondary endpoint; (c) has failed in its first two Phase III trials to show efficacy on blacks / African-Americans, who have a high risk of lupus; (d) has much more severe and frequent side effects than Lupuzor; (e) is very expensive for a drug showing slim efficacy, with the US price being $40,000, whereas Lupuzor is targeting $10,000 to $20,000 per patient; (f) was until recently administered by infusion taking an hour whereas Lupuzor is subcutaneous (though a more recent Benlysta subcutaneous trial was successful at the end of Phase 3 with similar efficacy over placebo as the infusion).
Benlysta’s Phase 3 trial results were 14% over placebo at 52 weeks in its first trial; 10.3% over placebo at 52 weeks in its second trial; 6.1% over placebo at 78 weeks in its second trial; and in a more recent subcutaneous trial (the previous were infusion) 12.3% over placebo at 52 weeks. It has recently passed a Phase 3 lupus nephritis trial that is a different indication to the SLE targeted by Lupuzor.
It is important to note that despite Benlysta's failings, Glaxo bought out HGSi, which owned 50% of Benlysta, for $3.6bn with Benlysta being the only drug HGSi had on the market, before any significant sales and with Benlysta struggling to make an impact on the market. HGSi had two other Phase III drugs in the pipeline.
The blockbuster market is therefore open to a new drug with good efficacy and a good safety record. Lupuzor has the potential to meet both these criteria.
The only other drug immediately in the wings is Anifrolumab (Astrazeneca), which:
- failed its first Phase 3 trial [36% active (high dose) vs 38% active (low dose) vs 40% placebo
just saying'' there is plenty of time for IMM to come good,
with this new FDA guidance
we may not have the deep pocket of GLAXO / AZN to pay off the FDA
for approval, wether it work or not, so we have to get it right 100% before
we tell the Market
GLA
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