DXB

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39.5¢ dimerix limited

I remember in one of their calls a while back Retrophin refused...

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HS2912

47 Posts.

07/10/20

01:44

Post #: 47897504

Originally posted by Owl vs Fox: ↑
Table 2.
Summary of treatment-emergent adverse events during the double-blind period (FAS)

Patients,n(%)
AE Irbesartan Sparsentan, All Doses
(n=36) (n=73)
Overall incidence of TEAEs
Any 26 (72.2) 56 (76.7)
Drug-related 13 (36.1) 32 (43.8)
Serious 1 (2.8) 2 (2.7)
Leading to study withdrawal 1 (2.8) 2 (2.7)
Death 0 0
TEAEs with incidence >5%
Headache 7 (19.4) 14 (19.2)
Hypotension/orthostatic hypotension 3 (8.3) 12 (16.4)
Dizziness 4 (11.1) 10 (13.7)
Edema/edema peripheral 1 (2.8) 9 (12.3)
Nausea 3 (8.3) 9 (12.3)
Diarrhea 1 (2.8) 6 (8.2)
Vomiting 1 (2.8) 6 (8.2)
Upper abdominal pain 2 (5.6) 4 (5.5)
Cough 2 (5.6) 3 (4.1)
Fatigue 4 (11.1) 3 (4.1)
Nasal congestion 4 (11.1) 2 (2.7)
Upper respiratory tract infection 2 (5.6) 2 (2.7)
Hyperkalemia 2 (5.6) 1 (1.4)
Muscle spasms 2 (5.6) 0
AE, adverse event; FAS, full analysis set; TEAEs, treatment-emergent adverse events.

Hi Leveller, we were discussing Spartesan AEs some time back, but easier to repost this table from Ph2 Spartensan trial results. There were no deaths & really very limited trial withdrawals due to AEs which you would expect to have some anyway. Things like anaemia & hyperkalaemia are a problem for people with CKD anyway.

The biggest problem appears to be oedema (which with treatment you would expect to be reduced) & orthostatic hypotension, which may be dose related & occurs with ARBs as well (hypotension). I think Spartensan has every chance of being a successful drug candidate, but so does DMX-200 & we have not seen these A/Es reported with this drug & a good safety profile in kidney disease. I think it will come down to safety & QOL with the least side effects for drugs to treat FSGS & CKD if they are showing similar efficacy, as kidney disease can make you feel pretty crook anyway when symptomatic.

Published trial results here from Ph2. As you know it’s now in Ph3.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6218860/
Expand
I remember in one of their calls a while back Retrophin refused to state how many patients in the Ph3 were staying on the upper dose (the study lets them step down) which doesnt sound massively encouraging for them in terms of the edema rates

I had a conversation with their CEO about a year ago and he couldn't give a straight answer about the decision to continue the higher of the two doses to Ph3, when they had just given a presentation highlighting the safety of the lower dose in Ph2.

I'm not sure sparsentan will be a magic bullet in fsgs by any stretch of the imagination

DXB Price at posting: 29.5¢ Sentiment: Buy Disclosure: Held

6 Upvote

2 Great analysis

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	Patients,n(%)
AE	Irbesartan	Sparsentan, All Doses
AE	(n=36)	(n=73)
Overall incidence of TEAEs
Any	26 (72.2)	56 (76.7)
Drug-related	13 (36.1)	32 (43.8)
Serious	1 (2.8)	2 (2.7)
Leading to study withdrawal	1 (2.8)	2 (2.7)
Death	0	0
TEAEs with incidence >5%
Headache	7 (19.4)	14 (19.2)
Hypotension/orthostatic hypotension	3 (8.3)	12 (16.4)
Dizziness	4 (11.1)	10 (13.7)
Edema/edema peripheral	1 (2.8)	9 (12.3)
Nausea	3 (8.3)	9 (12.3)
Diarrhea	1 (2.8)	6 (8.2)
Vomiting	1 (2.8)	6 (8.2)
Upper abdominal pain	2 (5.6)	4 (5.5)
Cough	2 (5.6)	3 (4.1)
Fatigue	4 (11.1)	3 (4.1)
Nasal congestion	4 (11.1)	2 (2.7)
Upper respiratory tract infection	2 (5.6)	2 (2.7)
Hyperkalemia	2 (5.6)	1 (1.4)
Muscle spasms	2 (5.6)	0

I remember in one of their calls a while back Retrophin refused...

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