InDex craters on phase 3 ulcerative colitis failure
InDex Pharma chief executive Jenny Sundqvist
InDex Pharmaceuticals has said it will abandon a phase 3 trial of its lead drug cobitolimod in moderate-to-severe ulcerative colitis, its only clinical-stage programme, wreaking havoc with its share price.
Shares in the Nasdaq-listed Swedish biotech lost almost two-thirds of their value after it announced that the TLR9 agonist was unlikely to meet the primary endpoint of its Induction Study 1, the initial dose-selection stage of its planned CONCLUDE programme for the drug.
The decision was taken on the advice of the study’s independent data monitoring committee (DMC), which took an interim look at the results after 133 patients had been enrolled into the study, around a third of the planned population, and concluded that it had failed the assessment for futility.
“We are following the DMC’s advice, as it is not ethical for either patients or investors to continue a study that is unlikely to meet the primary endpoint,” said InDex's chief executive, Jenny Sundqvist, on a call with investors.
The results remain blinded, and no more cobitolimod doses will be administered, but the study will continue to follow patients as per the protocol to try to understand what happened, she added. There were no new safety issues identified in the trial.
“The outcome confirms the complexity of this disease, and the need for further research in this field,” said Sundqvist.
Cobitolimod – a DNA-based oligonucleotide – was delivered to patients via an enema, and in prior studies was shown to suppress inflammatory processes involved in ulcerative colitis, protecting against tissue damage and allowing healing of the colon.
Sundqvist would not speculate on the implications of the trial failure on InDex as a company, but acknowledged in response to questioning on the call that liquidation and distribution of its cash reserves to investors was one possibility, depending on the outcome of its review of the data. It ended the second quarter with cash and equivalents of SEK 412.5 million (around $39 million).
Other than cobitolimod, InDex only has two preclinical-stage candidates for inflammatory diseases in its pipeline, so, the future of the company is likely to be closely tied to the outcome of its cobitolimod review, and the slim possibility that the programme could be saved.
Earlier this year, the biotech signed a license agreement for cobitolimod with Viatris, granting rights to the drug in Japan, in a deal worth up to $50 million. It has previously said that the potential sales for the drug could be more than $1 billion, if approved.
