Doomsayer- Scaremongering or....20 Mar 2020 16:26
Note BMS TYK2 included.....
Clinical trial delays become reality as Covid-19 risk spreads
Jacob Plieth
A Vantage analysis identifies 315 pivotal trials that risk, like Lexicon’s Scored and Soloist studies, never being completed.
As the knock-on effect of Covid-19 spreads far and wide, one aspect biopharma investors must consider is the risk that ongoing trials might be delayed or even abandoned. Yesterday Lexicon provided a case in point, cancelling two Zynquista studies that had recently completed enrolment of nearly 15,000 type 2 diabetics.
True, the coronavirus pandemic was only one reason cited, and it is likely that Lexicon largely wanted to end uncertainty and accept that a partner to fund the trials to completion would not be found. But Vantage has identified a further 315 pivotal studies due to end this year, in 172,104 subjects, that might suffer a similar fate.
Among these feature such projects as Pfizer’s Clostridium difficile vaccine candidate PF-06425090, whose Clover study is, with 17,525 subjects enrolled, the biggest in this analysis. A separate PF-06425090 trial, seeking to recruit 1,960, features among the top five studies reading out this year that have yet to enrol fully.
Under threat
A huge amount of clinical work is under threat, and this analysis sought to identify biopharma’s most advanced, and most valuable, crop of R&D assets.
To pinpoint studies with the most invested – in terms of time and money – Vantage searched specifically for pivotal-stage projects that have yet to receive US approval, in trials that have a 2020 primary completion date, according to clinicaltrials.gov.
The topline analysis reveals 168 trials still recruiting, and another 147 that are active but fully enrolled, comprising 64,856 and 107,248 subjects respectively. Remarkably, it looks like at least five near-term blockbusters are under threat: Lilly’s tirzepatide, Reata’s bardoxolone, Immunomedics’ sacituzumab govitecan, Bristol-Myers Squibb’s Tyk2 inhibitor and Galapagos’s filgotinib.
The exposure of Bristol is especially striking: four Tyk2 studies are due to be completed this year, plus another four of ozanimod. The latter project features in the contingent value right issued under the Celgene acquisition; as Stat News has pointed out, FDA review delays could mean that this CVR never pays out.
Blockbusters under threat? Projects in this analysis with biggest projected sales potential
Project Company 2024e sales ($m) Trial under threat?
Tirzepatide Lilly 1,619 NCT03882970
Bardoxolone methyl Reata 1,608 NCT02657356
Sacituzumab govitecan Immunomedics 1,365 NCT02574455
BMS-986165 (Tyk2) Bristol-Myers Squibb 1,178 NCT03611751; NCT03624127; NCT04167462; NCT03924427
Filgotinib Gilead 1,031 NCT02914522
Ozanimod Bristol-Myers Squibb 966 NCT02576717; NCT02435992; NCT03440372; NCT03440385
Efgartigimod Argenx 964 NCT03669588
Mirikizumab Lilly 848 NCT03535194; NCT03518086
AXS-05 Axsome 753 NCT02741791; NCT04039022
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