pharmafileJanuary 29, 2018
Tag: AstraZeneca , Inhaler
AstraZeneca has made a brief announcement that its triple therapy inhaler manage to successfully hit eight of nine primary endpoints in the treatment of moderate to very severe chronic obstructive pulmonary disease (COPD).
The Kronos trial was a 24-week, double blind trial to determine the efficacy of PT010 in patients who were given two doses each day.
The full data was not revealed but instead a list of primary endpoints was offered and the conclusions of which were met:
Over 24 weeks (post-dose*) |
Met |
Over 24 weeks (trough) |
Met |
Over 12-24 weeks (trough) |
Met |
At 24 weeks (trough) |
Not met; favourable trend |
Over 24 weeks (post-dose*) |
Met |
Over 12-24 weeks (trough) |
Met |
At 24 weeks (post-dose*) |
Met |
Over 24 weeks (trough) |
Met |
Over 12-24 weeks (trough) |
Met |
The results position AZ well to become the second to market, behind GSK’s recently approved Trelegy Ellipta. GSK’s product achieved approval in the US back in September and then followed this up with an approval from the EMA in November.
It will be able to build up a dominant lead over AZ’s product, should it also receive approvals but, depending on pricing, may be able to snag a small portion of the market for its product.
Dr Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer, said: "We are encouraged by the results of the KRONOS trial that has demonstrated PT010’s efficacy in improving lung function and look forward to the ETHOS exacerbation trial results in 2019 that will further characterise the role of this potential treatment for patients with COPD."
AZ acquired the rights to PT010 after its purchase of Pearl Therapeutics in a $1.15 billion deal back in 2013. It acquired its Bevepsi Aerosphere product in the same deal, though it took some time for this product to come to market in early 2017 but entered a crowded market in both the US and EU.
However, the suspicion was that AZ had primarily seen PT010 as the product with the greater potential and it stands in a good position to carve its own niche of the COPD market.
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