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The EURORA trial enrollment was finished 2 months ahead of schedule with a 10% over enrolled. This is a good sign because it means they have quality patients. Also, Management used 27 countries out of the 31 planned ones, so this also bodes well since they would logically leave the more risky ones to the end.
These 2 points prove that Safety was much better maintained during this trial than it was during AURA ( where they didn't have the financial luxury to go with the best trial centers), hence I am expecting a drastic reduction in the Death rate.
Could be, AMARIN went up 500% in a week when they announced their P3 results last year. No leak, no nothing, it was trading normally until the results announcement day, even though people knew that results were due that day. AUPH could do the same, it all depends on the results, and the odds are looking better with yesterday's NR
Yesterday's NR is very important from an efficacy stand point. it proved that VCS does NOT have any impact on the healing properties of MMF, unlike other CNIs like cyclosporine who "has resulted in a 30 – 50% reduction in MPA exposure when used in combination". The fact that VCS does not reduce the efficacy of MMF is resulting in higher CR rates and response durability as we saw in AURA.
The recent results in this DDI study is an indication that CR rates similar to AURA will become a normality in AURORA or any other future trial. Huge News yesterday
250,000 shares were bought after hours taking it to 5.38
Remember guys that this is all part of the TOTAL PACKAGE that is required for the approval of the drug , whether it is FDA, EMA or others.
Proving that we are the best in class when it comes to CNIs gives us a great boost in the approval process of the NDA next year. well Today's News moved us much closer to this approval.
This is excellent news. from the NR: "Data support differentiation of voclosporin as a potential best-in-class CNI "
Based on the timelines of the AURA results release (1 March 2017), I have always expected the results of AURORA to be released in the second week of December. I am expecting a steady climb during the next 5-6 weeks until the release of the Top line Data
I think you mean Selling has dried up
Ahead of the 48 weeks results PR that the company issued on March 1st 2017, Stock Price climbed for 5 consecutive weeks ahead of the results, jumping 60% from Jan 18 to Feb 28. I won't be surprised to see something similar ahead of the P3 results
The major catalyst will be the LN P3 results, which can triple the SP instantly
Regarding Safety, I am not expecting any Death this time in Asia since half of the Study sites are in Japan and South Korea. the other half is in countries that were used in AURA and didn't show any safety issues (except Philippine where the number of sites was reduced from 8 in AURA to 5 AURORA ,to remove the sites that had dead patients in AURA). Glad to see management taking mitigation action in this regard. Some patients in LAtin America sites could die depending on how sick they are and how thorough they follow their AEs , especially early in the trial.
but overall, I am expecting the number of dead patients to be reduced substantially with Asia now less risky than as it was in AURA trial.
Remember guys that the X factor in the AUPH trials is the extremely low steroid dose. This is their secret weapon. Other trials were starting with higher steroid dosage and tapering to 10 mg/ day at week 16 (and remaining there till end of the trial) AUPH is hitting 10 mg /day on week 6 and hitting 2.5 mg/day at week 16 and remaining there till end of the trial. this explains the low Placebo CR in AURA compared to other trials ( and it will go lower because they will have more Hispanic and Black patients who historically show more severe LN, for ex: black patients require MMF dose of 3 g/day and we are using 2 g/day; no wonder no black patient out of 5 achieved a CR in the AURA trial). Another example is the LUNAR trial which had a mean dosage of steroid of 12,8 mg/day from week 16 to week 52 because patients were not able to maintain an oral steroid dosage of 10 mg/day after week 16, particularly non responders, AUPH is forcing 2.5 mg /day after week 16. I am expecting the Placebo CR to be lower than the 24% we saw in the AURA trial.
Yes Jess I mean weeks
George Milne, Chairman of the Board bought 10,000 shares at 4.96 USD on Oct 16
BR, lower dose is more efficient and more durable , hence 100% of the patients maintained a CR between week 24 and 48 ( only 75% maintained a CR in High dose) but if you split the study time you can see that low dose is more efficient in the first 24 weeks (33% low dose vs 27% high dose at week 24) and high dose is more efficient in the second 24 weeks (20% high dose vs 16% low dose between week 24 and week 48). this proves that VCS is Dose Respondent, but when you consider the whole study , low dose is more efficient because it is more durable and has a quicker response. also the high dose had more AEs and you can see that in any of the company's presentations.
Regarding the Dosage Response, High Dose VCS had a better CR in the second 24 month than Low Dose since we jumped from 20% to 40% (20% increase) versus 33% to 49% (16% increase). now why is it 20% ? coz the High Dose had a 25% relapse after the first 24 months due to increased AEs that took it from 27% to 20% (in other words, those 25% were responders that discontinued the trial because of the increased side effects). this means VCS responds to increased dosage, but looks like it takes it some time to do so(24 to 48 months instead of 0 to 24 months). the 23.7 dose was not chosen because it is more potent that the 39 dose but because of the side effects and increased AEs.
Lots of scare monger here without understanding the difference between AURORA trial and the rest of trials. one big difference between AURORA and AURA is the number of Hispanic and Black / Mixed race. in AURA those 2 ethnic categories presented 18.5% of the whole study. in AURORA study they should represent around 45% based on the site locations. But when we look at the Placebo values in AURA we see that 0 out of 10 patients achieved CR for the Other category (Black + Central America). Does it mean that the Black and mixed race in AURORA will achieve ZERO CR ? of course not. to find clues on the CR % for Black and Mixed races we can compare MMF numbers of previous trials . 2 examples:
1) the ALMS trial which was a Global trial too and covered various ethnic groups. the CR at 26 week was 8% for MMF group. This trial included around 27% of Blacks and Mixed races, and over 40% Hispanic ( of course some of the Hispanic could be part of the Aztec/Mexican mixed race category). but this 8% gives you an idea of the CR rate
2) the LUNAR trial which was a US trial equally broken down between Black / Hispanic / White. The MMF treatment had a CR at 52 weeks of 31% with no big difference between ethnic categories.
so why do we have this big difference between the 2 trials and which one is the right one ? first the study protocol and his stringent it is when it comes to CR conditions. 1)The LUNAR study had all patients Class III or IV ( ALMS and AURORA have pure class V). 2)the MMF was 3 mg / day in LUNAR and ALMS ( it is 2 in AURORA). 3) you can use rescue medication if you stay under 2 weeks in LUNAR and you can increase Steroid (in AURORA you can use up to a total of 1 week only and no more than 3 consecutive days and steroid use can not go over 10 mg / day) 3) in AURORA GFR reduction of < 20% makes you NR ( this does not exist in ALMS or LUNAR). 4) the Average daily Steroid dose for LUNAR after week 16 was 12.5 mg / daily when it is 2.5 mg in AURORA.
so this is just to tell you that numbers vary between one trial and another depending on how difficult are the trial conditions and CR conditions. I believe the AURORA (same as AURA) conditions are very strict and this explains why ZERO out of 5 blacks and 5 mixed Raced made any CR at 52 weeks in AURA . I don't know how VCS will perform with the Black category (no data in AURA for that) and same for Hispanic (even though we had 44% CR over 9 patients, which is still not enough but sure hell better than ZERO over 10 encountered in the MMF arm)
I am still extremely positive with the study result, it may not be higher than AURA due to the fact that Blacks / Hispanic are harder to treat than others but MMF too will be lower so that the P value between VCS and MMF will be statistically significant
As for safety, I already mentioned that the quality of the sites ?countries in AURORA is better than AURA. more safety measures were invested on the study sites, and since most of the death (9/13) happened in the first 2 months, AUPH team know that patients with AE will be thoroughly followed up in the first 2 months of the study (lessons learned)
Pete, on the contrary, this trial will have better numbers simply because you will have more Hispanic and Black patients, and those are known that they don't respond well to current SoC. actually there was 5 Black patients in the AURA trial in the Placebo arm and they all showed NR. not to mention that the Steroid dose used in the AURORA trial is so low that the MMF arm response will be lower than the other LN trials going on with other companies. No trial has reduced the steroid to the level that AUPH is doing ( without any impact in the VCS arm efficacy, but definitely impacting the Placebo arm efficacy)
The only risk remaining would be the safety ( since the efficacy was proven at P<0.001 which means there is 0.1% chance that the results were caused by CHANCE).
so safety remains as a risk, but this risk was substantially reduced, not only with the mitigation measures and the severe vetting that the company did for the selected sites, but also the quality of sites selected. in phase 2 we had 6 sites out of 86 (7%)related to the Indian Subcontinent (Bengladesh and Siri Lanka), and those sites were able to recruit a whopping 60 patients out of 265 (23%). this was ridiculous and opened the gate to many mistakes and patients death.
in phase 3 , those 2 countries were removed, we have 187 sites for 358 patients, less load for each site (lessons learned from phase 2) and sites were better selected. Actually my analysis show there is only 5 countries that COULD present a safety challenge and if patient randomization is better implemented this time (and it should) there are only 9 to 10 patients at risk. to prorate the same % of death that we had in phase 2 from the 6 sites in Asia ( which were 9 deaths over the 22 patients treated with low dose (41%)) and considering the same rate for remote sites ( even though a site being remote does not automatically mean it present a safety risk if patients selected are of a good quality) then we are talking less than 4 death here or around 2%. I take these results any day
a quick answer to that shorter article :
1) regarding the numbers of patients that completed CR in the low dose, it was 29 https://www.ncbi.nlm.nih.gov/pubmed/30420324
2) regarding the patients who completed the trial. it was very clear in the company presentation that 16 in total didn't complete the trial. 10 of them died ( 5 while still taking VCS and 5 after they stopped taking VCS) . so the number is 16 and NOT 21 . And regarding the 11 that he mentioned 6 quit for different reasons and 5 quit before they died, but the total is 16 (including the 10 dead).and the regarding the 10 dead, everyone know by now that it had nothing to do with the drug
so this article is a clear short attack ahead of the coming results. the writer is trying to play on numbers and create a foggy environment just to raise doubts in those who did not do enough DD
Jesspro, this analysis was only done for Aurinia based on the CR rates that management showed in their AURA presentation. Sites were taken from CLinicaltrial.com site. it shows the countries and the sites in each country. Overall it shows 31 countries but management in their latest MD&A confirmed only 27 countries. My death risk analysis was based on the 31 countries mentioned in clinicaltrial.com site (conservative compared to 27). The countries where I considered there is a risk of patient death are : Colombia, Guatemala, Puerto Rico, South Africa, Vietnam. 3rd world countries where sites are in the capital were not considered since it is not a remote site. Based on the 5 countries mentioned above there are 9 patients at risk in each arm. I assumed 50% death in the low VCS dose hence 2.2% . I could add the analysis here for public commentary but I don't know how to attach an Excel file in this forum. cheers
I have done a simulation based on the sites in the AURORA trial and the sites representing death risk for the patients. I used CR % from AURA trial and adjusted to the death ratio. this simulation covers 2 possibilities ( one Geographic and another one Ethnic) adding an adjustment of 30 Asian ( they recruit faster than white sites).I doubled the numbers of black patients from AURA trial since the sites in the US doubled. I added a table for AURA results just to confirm that my prorata is right and it matched. Final numbers show a min of 26.5% delta with placebo (48.5% vs 22%)
This is a message to the market that the recent decline in SP has nothing to do with bad results. An officer does not have to buy for >100 K to show confidence in the company. Investors, when they see a big chunk of officers buying in the open market for 10, 20 or 50K values should understand the bullish signal management is trying to send when it comes to the coming results
Insiders in AUPH have been buying a lot in October. this is all you need to know about the coming results
https://simplywall.st/stocks/ca/pharmaceuticals-biotech/tsx-aup/aurinia-pharmaceuticals-shares?utm_medium=finance_user&utm_source=yahoo&blueprint=821506#insider_trading
Hi Guys, new here, done a lot of DD on AUPH. wanted to share my thoughts regarding the recent SP decline. the same thing happened end of 2016 when the SP lost 50% of its value between mid Nov and end of Dec 2016 before picking up on 24 Jan 2017, which was 5 weeks ahead of the results on 2 Mar 2017. since management mentioned that results will be released by end of this Quarter (I am assuming mid Dec) we should expect the same kind of stock fluctuation until we reach at least Nov. so I don't see any negative leak right now, only a deja vu. cheers