from
Compstatins: the dawn of clinical C3-targeted complement inhibition, by the Lambris lab, UPenn, 2022. (patents to Apellis)
www.sciencedirect.com/science/arti...
Fascinating read and even more fascinating prospects for the effector end, C5aR1 antagonists
#APLS #IFRX

Very important indeed !
#MADA make America decent again
#TheRuleOfLaw

Full 33mn speech
youtu.be/HLHB5zFM_vs?...

pca.st/episode/de5a...

?

Finally on vilo, I don't have much hope in the ARDS BARDA trial, the inclusion criteria are not stringent enough. On the other hand Staidson is making good progress with both vilo (BDB-01) but also the follow up IFX-2 (STSA-1002).

$IFRX $UCB $NVS $MLTX $AMGN $BIIB $SNY $CLDX

On the competitive front I don’t give the big boys (Novartis with the recently approved BTK in CSU, Sanofi with Dupi or the JAKs in HS) much chance to move the needle. As to new targets, I’m not excited by c-KIT mAbs (Celldex etc) in CSU, and it’s much too early for the oral (BlueprintBio/Sanofi)

Biogen’s newly in-licenced C5aR1 inh won't be in the clinic for another 2 years, that’s more than enough for IFRX to find a big pharma partner and setup a rigorous registrational development program (ANCA, HS and CSU to start with, but not limited to)

Amgen are aware they bet on the wrong horse.
Avacopan sales still look good on a y/y basis but practically flatlining q/q. US quarterly sales hover around $100m and RoW sales are range bound between 5m and 10m. Also the only running trial is a paediatric extension in the approved ANCA indication.

CSU pointers at 4W UAS7
any reduction >10 is a hit (see below p24 August deck)
Unfortunately the anti Ig-E refractory cohort wont be available yet. More potential for positive data within weeks.

other key readouts
- steady state AUC(0-12h). Based on FDA filing docs in ANCA avacopan 30mg AUC(0-12h) is 3500 h ng/mL
- safety: super important vs avacopan liability with CYP3A4/5 (see latest Japanese observational study)
- pain: could be an easy and differentiating hit

By lesions in detail at 4W
Novartis secukinumab: nodules -3 (10 to 7), abscesses -1,5 (3,5 to 2) and draining tunnels -0,5 (2,5 to 2)
UCB bimekizumab:nodules&abscesses -2,5 pcb vs -6 bime, draining tunnels -0,25 pcb vs -1 bime