Blow for BioInvent as vascular treatment fails

pharmafile | July 11, 2012 | News story | Research and Development, Sales and Marketing BI-204, BioInvent, LDL, Sweden 

Swedish biotech company BioInvent has suffered a new blow with the failure of its lead pipeline candidate. 

The company’s share price fell sharply after novel anti-cholesterol treatment BI-204 failed to meet its primary endpoint in a key Phase IIa trial. 

BioInvent has been developing the drug with Genentech, and had hoped the treatment could reduce inflammation in arteries caused by LDL cholesterol, and ultimately reduce the risk of heart attacks and strokes. 

The results may force the partners to pull the plug on the drug, the Swedish firm’s lead candidate, which would be a grave setback for BioInvent. 

The company is still coping with the impact of a major setback to another key molecule, TB-403. In June Roche pulled out of a co-development deal on the drug, a potential cancer and ophthalmology treatment. Roche exited the deal as part of a wider portfolio review, and the rights have now been returned to BioInvent and its other co-developer ThromboGenics. 


In the Phase IIa study, BI-204 was administered either as a single dose or in multiple doses over a twelve-week period in addition to standard-of-care. The primary endpoint of the study was the relative change in inflammatory activity in an index arterial vessel after twelve weeks, as measured by FDG-PET/CT imaging ([18F]-2-deoxyglucose positron emission-tomography/computed tomography). 

No statistically significant reduction between placebo and the two active treatment arms was observed, therefore the study did not meet its primary endpoint. 

Data shows BI-204 was well-tolerated and had no drug-related safety signals were identified – but the lack of efficacy signs are not promising. 

Svein Mathisen, chief executive of BioInvent, said: “Before deciding on the future of BI-204, we and our partner Genentech need to finalise the full data analysis. We expect to provide an update later this year.”

The company had already announced plans to reduce its headcount and other costs following Roche’s exit from the TB-403 deal. 

The workforce will be cut from 89 to 68 full-time employees, with these and other costs aimed at saving  SEK 15 million ($2.1million) a year. 

The company has one further molecule in development – BI-505, a cancer treatment it is developing in-house.  The monoclonal antibody is currently in a dose-escalation phase I study in patients with relapsed or refractory multiple myeloma.

Andrew McConaghie

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