USA-based KaloBios Pharmaceuticals (Nasdaq: KBIO) revealed disappointing top line results from a Phase II study on KB003 in patients suffering from severe asthma , which failed to meet the key endpoints. The firm’s shares plunged as much as 50% on the news.
The Phase II randomized, double-blind placebo-controlled study failed to meet its primary objective of improvement in FEV1 (a measurement of pulmonary function) in comparison to placebo. KaloBios has decided not to develop KB003 further for the treatment of severe asthma.
KB003 also failed to demonstrate meaningful reduction in exacerbations in the overall study population or in any material subgroup compared to placebo. No significant improvements in questionnaire scores related to asthma control were observed during the study in the overall patient population. KB003 was however generally safe and well tolerated during the study, which was eventually over shadowed by the failure to meet key endpoints.
Pipeline needs to deliver says Zacks analysts
Analysts at Zacks Equity Research commented: “We are highly disappointed by the news on KB003. KaloBios does not have any marketed product. Consequently its pipeline has to deliver. Similar pipeline related setbacks will be catastrophic for the company.”
Following the decision not to develop KB003 further for the severe asthma indication, KaloBios now intends to concentrate on the two other candidates in its pipeline, KB001-A and KB004.
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
7 day trial access
Become a subscriber
Or £77 per month
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze