Friday, October 18, 2019 6:13:13 AM
This updated Bridge data again is quite astounding, PRX-102 effectively halts their eGFR slope decline. Comparing -5 per year to -0.23 per year.
This is consistent with the Phase I/II data which showed a eGFR slope of -0.82 after 2 years on PRX-102.
This compared to Fabryzye with an eGFR slope of -1.89 to -6.82 per year dependent on level of severity. Which is consistent with the Replagal -6.8 per year.
Again with Fabryzyme being essentially the same molecule as Replagal, this should show the same level of superiority against Fabryzyme.
Additionally and of importance for AA, is that "Pegunigalsidase alfa was found to be well tolerated in the study, with all adverse events being transient in nature without sequelae. Most of the patients who were eligible for home care therapy per country regulation were treated under a home care arrangement in which certain of the scheduled infusions were performed at the patients' home."
And that again the majority of these patients having completed the 12 months are continuing on PRX-102.
So it would seem AA should be smooth sailing.
I again also expect us to see some interim Bright data pre-end 2019. Perhaps we'll hear something on that at the next call. Will be interesting to see if they provide a breakdown based on patients that we previously in Replagal vs previously in Fabryzyme.
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