I am surprised that there are so few new oral drugs coming out for IBD. I guess Infusions are all the rage due to potential profits. AJM300 has been around for a while, and I remember seeing an abstract for it at DDW last year.
This Article – in Gastroenterology, which has been online for a while, finally came out in print edition.
AJM300 is an alpha4 integrin antagonist. In their paper describing a double-blind, placebo-controlled phase 2a study, AJM300 was shown to be well tolerated and more effective than placebo including both clinical response, remission and mucosal healing.
For those of you like me, who do not remember what Phase 2a is – Pilot clinical trials to evaluate efficacy ( and safety) in selected populations of patients with the disease or condition to be treated, diagnosed, or prevented. Objectives may focus on dose-response, type of patient, frequency of dosing, or numerous other characteristics of safety and efficacy. (2B being a larger study showing efficacy, the so-called “Pivotal trial”).
Another interesting statement in the article made me aware of the number of cases of PML as a result of Natalizumab treatment – 2.1 cases per 1000 (total of 212 cases out of 99,751 patients treated). Two take aways for me – I had no idea that many patients were treated with Ntalizumab!!!I had no idea that there was a registry, but that makes sense.
Once again, remember, JCV negative patients never get PML.
Lastly, efficacy in this group: I will only mention mucosal healing which is most important for these pilot studies: 58.8% – AJM300 versus 29.4% in placebo group. – another reminder that a third of patients with UC will just get better.