Just following up on this earlier post concerning ruxolitinib (Jakafi):
Incyte /Novatis working in conjuction
Treatment of Covid/ARDS in ventilator dependent patients -- Phase 3 RCT with 500 subjects. -- Estimated Completion Date 29 September 2020 (but see below!)
Some further details:
Incyte's Phase 3 RCT --- 400 subjects --- Covid/ARDS patients who are pre-mechanical ventilation.
I mentioned that there were two phase 3 studies of Jakafi underway. This is from a media report of 7 May 2020:
Novartis and Incyte Plan Second Phase 3 Trial of Jakafi for COVID-19May 7, 2020Incyte and Novartis are planning a second phase 3 clinical trial in the U.S. of their JAK inhibitor Jakafi (ruxolitinib) as a COVID-19 treatment.The trial will evaluate the drug’s safety and efficacy along with the standard of care compared to standard-of-care therapy alone in COVID-19 patients on mechanical ventilation and who have acute respiratory distress syndrome.The companies launched a phase 3 trial of Jakafi last month to treat cytokine storm — an immune response in which the body attacks its own cells — in COVID-19 patients.Incyte has also launched an expanded-access program in the U.S. to make the drug available for eligible patients with COVID-19 associated cytokine storm. — Jordan WilliamsThere was a recent conference call held on 4 August discussing Incyte's 2nd qtr results. Curiously, not was much said at all about the Covid/ARDS trials except in answer to a question. Here is what was said:
Interestingly, Stein said that the second study (ie. involving ventilator dependent patients) is running behind because there is less ventialtion occurring and that
they hope to have data before the end of the year!
Nothing was said about the possibily of early stopping or interim read-outs. So its seems that there is not much to see here until year's end or later.
They are both also running Expanded Access Programs for patients suffering severe Covid/ARDS.
Even if Jakafi works in Covid/ARDS patients, I seriously doubt that it is capable of achieving the response/survival rates that we are expecting remestemcel to achieve. We know about the side effects (thrombocytopenia, amenia & neutropenia & others) . How important these are in this patient population I don't really know. But at this stage there is no reason to think that Jakafi targets the respiratory system anywhere nearly as effectively as remestemcel does.
Dr Itescu has been talking for a while now about the ability of remestemcel to improve respiratory function, a point that finds support in the EPA results and the post-hoc study of patients with obstructive pulmonary disease. I think the post hoc study would have played as big a part in getting the NIH interested as the EAP results did. There is nothing I can see from Incyte/Novartis showing the same promise. Discussion of the whole topic in the Incyte conference call was decidedly muted. But who knows what else they may have that they are not making public.
So there are potential competitors out there iin the ventilator dependent Covid-ARDS space. What we must now look for are:
-- superior efficacy;
-- superior safety/risk proile;
-- first mover advantage.
The second is almost a given. Regarding efficacy, we can now only wait and see. As for first mover advantage, we will need a very large partner and/or partners if we are to capitalise on this. I'll let others guess as to who it or they might be, and when the rnecessary arrangements are likely to be announced.
(20min delay)