BT-600 aims to deliver tofacitinib, the active ingredient in Pfizer’s Xeljanz, directly to the colon as a new approach to tackle the unmet needs of targeted drug delivery.
This drug-device combination will be beneficial to patients with UC as there is less systemic exposure of the UC therapeutic delivered, leading to a more favourable safety profile and better clinical outcomes, according to data and analytics firm GlobalData.
Asiyah Nawab, pharma analyst at GlobalData, said: “BT-600 has potential in providing efficacious and targeted therapy to the colon of UC patients for the delivery of the drug. The drug-device combination will be met through the NaviCap targeted oral delivery platform, which releases the therapeutic drug based on the gastrointestinal tract’s anatomy. The drug delivery device’s ability to identify the target site and release the drug means less systemic exposure that could potentially reduce adverse effects and toxicity.”
Currently, patients receiving treatment for UC require a lifetime of continuous therapy and monitoring.
Available treatment options include anti-inflammatory agents, with 5-amino salicylic acid (mesalamine) as the mainstay treatment for mild to moderate disease, and biologics used to delay surgical interventions in moderate to severe UC patients who are refractory to other therapies.
Despite the many treatment options for UC, key opinion leaders interviewed by GlobalData have expressed a lack of efficacious treatment alternatives, with issues pertaining to not only safety and efficacy but also compliance.
Nawab continues: “Biora’s drug-delivery device may allow better compliance to existing UC therapies due to preferred safety profiles, achieved by local delivery of therapeutics rather than systemic delivery.”
The combination may also be favoured over conventional delivery routes, including parenteral and rectal in UC patients, perhaps tackling the issue of adherence and compliance to UC therapies as it is able to deliver the drug in 500ul doses at the target site.
Nawab concludes: “While it is early days for Biora’s new ‘smart pill’, it represents a potentially new treatment modality and one that may increase the efficacy of therapeutics in the specified tissue. For that reason, the clinical trial data for this drug-device combination will be one to keep an eye on.”
