Immupharma Share Discussion Threads

[glennrcharles] 06/4/2018 19:02

Just hope they've patented the placebo..

[h2owater] 06/4/2018 18:57

ImmuPharma Expects Top-Line Results of Lupuzor Phase 3 Trial by Mid-April

APRIL 4, 2018

Jose Marques Lopes, PhDBY JOSE MARQUES LOPES, PHD IN NEWS.


ImmuPharma Expects Top-Line Results of Lupuzor Phase 3 Trial by Mid-April

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Top-line results of ImmuPharma’s Phase 3 clinical trial testing Lupuzor (rigerimod) as a systemic lupus erythematosus (SLE) treatment are expected by mid-April, according to the company.

ImmuPharma also announced that database lock of the trial is expected by April 6. This milestone prevents unauthorized or unintended alterations to the information obtained during the double-blind study (NCT02504645). This is especially relevant for double-blind trials, in which investigators do not know if they are using the treatment candidate or a placebo.

The 52-week study, which began in June 2016, evaluated the effectiveness and safety of Lupuzor plus standard therapy in SLE patients. The trial was conducted at 30 centers worldwide.

A total of 200 adults were randomly assigned to receive 200 micrograms of Lupuzor or placebo under the skin every four weeks for 48 weeks. All patients also received the standard therapy.

In January 2018, ImmuPharma announced the trial’s completion. Results showed a robust safety profile over one year of treatment with Lupuzor, also known as IPP-201101.

“With the continued robust safety record of [Lupuzor] achieved over this trial, we look forward with confidence to reporting top line results in the near future,” Tim McCarthy, chairman of ImmuPharma, said in a press release.

The company also announced that, following requests from both patients and researchers, it was initiating an extension study with participants from the Phase 3 trial, who will receive Lupuzor plus standard therapy for an additional six months. Data analysis in this follow-up study will be independent from that of the Phase 3 trial, the company said.

Lupuzor is intended to regulate the immune system without affecting healthy cells, allowing them to remain active to fight infections. The investigational medication inhibits the activation of auto-reactive T-cells — a type of white blood cell — which attack the body’s own tissues. ImmuPharma says that Lupuzor’s ability to avoid targeting healthy cells makes it different from other immune-modulating therapies.

ImmuPharma announced the recent updates after they were informed of them by Simbec-Orion, the company conducting the research.

Lupuzor had been granted fast track designation by the U.S. Food and Drug Administration, which is intended to speed up development and approval of new treatments that meet unmet medical needs. The FDA had also approved a special protocol assessment for Lupuzor’s clinical trials, which means the agency will accept the studies’ results if they are positive.

[top tips] 06/4/2018 18:55

Lupuzor Phase 3 was comparatively small at just 200 patients so results should be out mid month as previously suggested by IMM.

[glennrcharles] 06/4/2018 18:54

I'll take your word for it about the timing. But having worked in IT I can't but feel that it should be possible to get an initial indication reasonably quickly. After all anything that a person can do that can be weighed or measured can be automated. Unless there is a skill in selectively highlighting features that best show the efficacy. writing a report I agree probably takes 2 weeks...

[ny boy] 06/4/2018 18:44

Ffs, the results will not be before mid April, I spoke to a clinical trial data boss a while back, he says always allow 2-4 weeks from the time the data lock date and the stats guys to do their analysis , he said to me often it takes at least 4 weeks before the final phase 3 clinical trial report is submitted to a Client.

Forget about results on Monday, if you understand the process you will know the approx timetable.

[andyr42] 06/4/2018 18:36

remarko, still same old one liners. how you doing little boy? are you still in imm or just shouting from the fence like many others who joined recently. A few vile characters and they know who they are. Fingers crossed for next week or week after. Things are hotting up judging by the spate of big buys in past few days/wks. Have a wonderful weekend investors/punters.

[harbourside] 06/4/2018 18:33

From an IT perspective I know that once a database has been populated with all relevant data then a DBA can pull any type of raw data from it that is required by running appropriate jobs, it won’t be pretty and presentation standard but the data is the data, that’s not going to change once a lock is in place, so from an IT view it’s possible to get a preview if you like of any data contained on the database in a matter of hours. That said, as NJB67 has kindly pointed out previously, from a Pharma point of view this is not the done thing and a company does not report until they get the first presentation from SO, which presumably due to the manual intervention and creation of the document, checking etc, takes up to 2 weeks. So anyone’s guess really. Didn’t expect an RNS stating DB lock today, the last RNS was clear enough, expected to be locked down by 6th April, as we haven’t heard to the contrary I consider it locked and next RNS to be top line results, although the title of SM’s talk on Monday ‘Treating Lupus, from innovation to drug’ is intriguing. Exciting times, especially seeing those big trades go through the last two days, GLA holders.

[h2owater] 06/4/2018 18:22

Muller's new medication, marketed as Lupuzor and expected to be launched in 2018!Hold tight for the launch!

[davew28] 06/4/2018 18:21

"SM does regular presentations. I'm assuming that this one is no different to previous and not the presentation of p3 findings" #23691

This one is more relevant as it's all about Lupuzor the drug:

Treating Lupus without any side effects: from fundamental innovation to drug

[goodbloke1] 06/4/2018 18:17

What makes you think results on Monday,

[dontshoutatonce] 06/4/2018 18:16

remarksome, yes, it is a lot of money but logically, following the facts, the winds are with us, but I don't want to tempt fate in any way at all.

[hamhamham1] 06/4/2018 18:08

Maybe Warren Buffett bought some today ?

[drsmessguide] 06/4/2018 18:03

Woodford getting some late action? I don't think he holds this in the patient capital fund

[andrbea] 06/4/2018 17:45

250k at 175p = £437.5k (that 12.11 trade), reported late

not exactly small is it....

[che7win] 06/4/2018 17:42

Divine, This day and yesterday, 250,000 buy trades imho.Clear to me that someone is eager to buy as many shares as possible.New Derampers must be trying to help facilitate whoever this buyer is.

[pretax2] 06/4/2018 17:35

SM does regular presentations. I'm assuming that this one is no different to previous and not the presentation of p3 findings. There may be a few leaks though.
I'd love to ve a fly on the wall, but would need an interpreter no doubt.

[divinessence] 06/4/2018 17:33

Must admit I am nervous now as the results get closer, but hung in there since last year through thick and thin and the de-risk, re-risk then de-risk and finally re-risk again. Lets hope for rewards for the patient. GLA.

[che7win] 06/4/2018 17:29

Agree Chadders.

[che7win] 06/4/2018 17:28

Makes sense Divine on both counts.More sells by nervous PIs and a drop this afternoon to fill those orders.Someone is buying 250k each day imho.

[chadders] 06/4/2018 17:28

kevwin, keep it up matey, no idea what you're posting but it does add a touch of class amongst all the filth.

Sicilian kan must be regreting the day he spent so much valuable time creating a quality thread that has been totally trashed by students and teenagers.

[divinessence] 06/4/2018 17:24

che7 both 250K and 75K look like buys to me?

Don't think we'll see the results on Monday, more like eow i think.