{"id":1757,"date":"2015-07-21T03:03:01","date_gmt":"2015-07-21T07:03:01","guid":{"rendered":"http:\/\/allphasepharma.com\/dir\/?p=1757"},"modified":"2015-07-28T15:42:42","modified_gmt":"2015-07-28T19:42:42","slug":"the-demise-of-kb001-part-i-an-anti-pseudomonas-antibody-hits-the-dust-instead-of-paydirt","status":"publish","type":"post","link":"https:\/\/allphasepharma.com\/dir\/2015\/07\/21\/1757\/the-demise-of-kb001-part-i-an-anti-pseudomonas-antibody-hits-the-dust-instead-of-paydirt\/","title":{"rendered":"The Demise of KB001 (Part 1): An Anti-Pseudomonas Antibody Hits the Dust (Instead of Paydirt)"},"content":{"rendered":"

\"KaloBios<\/a>
\nIn January this year, Kalobios informed investors that KB001-A had failed to meet efficacy criteria in a Phase 2 trial of cystic fibrosis (CF) patients.\u00a0 In this well-controlled well-executed placebo-controlled trial of182 patients, the primary endpoint and just about every other efficacy endpoint of interest was missed.\u00a0 Neither did KB001 show a hint of activity in subset analyses.<\/p>\n

Why did KB001 miss its primary target of ‘prolonging the exacerbation-free time span’?\u00a0 No explanation was provided by the company nor from the scientific community, nor from the usually astute group of investment advisors that follow VCs and make important Buy\/Sell recommendations.\u00a0 Were there any warning signs, dark clouds over the project which could have alerted us to the impending doom?<\/p>\n

Let us do a quick post-mortem and review\u00a0the reasons to believe why\u00a0KB001-A should have\u00a0worked. The importance of the pseudomonas TTSS for delivery of virulence factors is and remains solid; the animal models showed clear benefit when PcrV was blocked by KB001; the drug was safe in all clinical studies and at all dose steps tested; the pathogenic role of P. aeruginosa in VAP and CF patients is unquestioned; there were hints of efficacy in the early stages of the program.<\/p>\n

The scientific approach was deemed solid and the early clinical data promising enough: On 1\/11\/2010 Sanofi Pasteur bought into the program and partnered with Kalobios. In the spirit of true collaboration, they took over the \u201cPseudomonas VAP\u201c indication while Kalobios concentrated on the CF indication.\u00a0 And on 4\/23\/2013 the program was given Fast Track status by FDA.

We interpret these actions to mean that nothing was fundamentally wrong from a scientific perspective<\/span><\/p>\n<\/div><\/p>\n

We interpret these actions to mean that nothing was fundamentally wrong from a scientific perspective and that the\u00a0data at the time were convincing enough for Sanofi\u2019s and the FDA\u2019s action.\u00a0 However, on critical review, the\u00a0data at the time were still rather thin:<\/p>\n