Galapagos Phase 2a psoriasis study results

[Fred]

Following on from Galapagos announces phase 2 study Galapagos have released the following information.

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“Study JAK116679 was a phase 2a multi-centre, randomised, double-blind, placebo-controlled, dose ranging study (100mg bid, 200mg bid, 400mg bid) that evaluated the safety and efficacy of GSK2586184 compared with placebo in 66 patients with chronic plaque psoriasis. Preliminary results showed that a significantly higher proportion of patients treated with GSK2586184 at the 400mg bid dose met the primary endpoint compared to placebo. The primary endpoint was defined as achieving ≥75% improvement from baseline in Psoriasis Area Severity Index (PASI75) score at Week 12. PASI75 for patients randomised to placebo was in the range expected.

During the treatment period the most common adverse events occurring with a frequency of more than 20% on either placebo or pooled GSK2586184 were headache (36% placebo, 27% GSK2586184) and nasopharyngitis (21% placebo, 29% GSK2586184). A final analysis of the data from study JAK116679 will be submitted for presentation at an upcoming scientific congress and/or a peer-reviewed publication. GSK remains responsible for the study and intends to review the complete data from all GSK2586184 studies before determining next steps.”

“We at Galapagos are pleased to hear that GSK2586184 met the primary endpoint in GSK’s psoriasis study. This is the second selective JAK1 inhibitor and candidate drug based on Galapagos’ novel target approach to show efficacy in patients. The next patient readout from our pipeline is expected in June 2014: our Phase 2 Proof of Concept study with GLPG0974, a fully proprietary and novel mode of action in ulcerative colitis,” said Dr Piet Wigerinck, Chief Scientific Officer of Galapagos.

GSK2586184 is a selective JAK1 inhibitor which was discovered and developed within Galapagos’ inflammation alliance with GSK. GSK in-licensed the molecule in February 2012, gaining worldwide rights to further development and commercialization. Galapagos is eligible, without further financial investment from Galapagos, to receive from GSK up to €34M in additional milestones, plus up to double-digit royalties on global commercial sales of all therapeutic indications of GSK2586184.

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[jiml]

A very promising article seems very positive fior tihe future for psoriasis sufferers .
It may well be another tool in the dermatologists armour in the future. It seems the trials went well. I will look forward to June when the next results come out.

I appreciate it cost a lot of money to develop , butI just wonder what the cost will eventually be for our health service and insurance based healthcare

[Fred]

But I just wonder what the cost will eventually be for our health service and insurance based healthcare

That will have to be seen, but modern medications are more expensive these days and you don't get many chips in a bag for a Tanner either

I hate fat cats getting fatter, and I do sometimes wonder how they can justify the cost of my Stelara. But then again I sometimes look at it another way, without Stelara my life was hell, I've paid my dues so have no worry about getting a treatment that is made available free. And another thing I sometimes think is, would they continue to make better treatments if there was no profit to put back into the next venture.

Did you know NASA paved the way for Biological treatments of psoriasis

Fred goes off to buy more shares in Galapagos

[Caroline]

We are still aiming at the toolbox of the dermatologist, but...
Still a whole other thought could be, that if DMF breaks through in the treatment of MS, there could be a change, as finally it might be that it comes to their mind that psoriasis is not a skin disease, but a immuno disease, so it does not belong at the dermatologist.
It will take some time, but there is an opening, made by industry itself.

[Fred]

We are still aiming at the toolbox of the dermatologist, but...
Still a whole other thought could be, that if DMF breaks through in the treatment of MS, there could be a change, as finally it might be that it comes to their mind that psoriasis is not a skin disease, but a immuno disease, so it does not belong at the dermatologist.
It will take some time, but there is an opening, made by industry itself.

I think the problem with it being linked to the dermatology department is because that's the way it has always been as it was thought of as a skin problem, however like you I agree "It's not a skin problem" (yes I know that's 2 agreements between us this year) but it would mean changing all the departments in hospitals and the specialists would all have to re-train in their chosen field.

[mataribot]

In the end it doesn't really matter - people with psoriasis have a higher risk of developing other skin issues such as cancer. Seeing a dermatologist at least semiannual would be advised. Besides the old school drugs such as MTX, the drugs manufacturer gives explicit instructions on how to use and monitor the drug.