Basilea drops inhaled antibiotic, expands cancer program in early-stage rejig

Basilea Pharmaceutica (SWX:BSLN) has reshuffled its deck of early-stage prospects, culling an inhaled antibiotic from its pipeline while broadening the scope of a cancer R&D program. The moves see the Roche ($RHHBY) spinout discard the antibiotic 11 months after revealing its interest in the program, and go after a new indication with its small molecule tumor checkpoint controller.

Basel, Switzerland-based Basilea went public with its inhaled antibiotic plans in September, at which time it committed €5.5 million ($6.1 million) to a consortium to hustle the drug toward the clinic. The drug, monosulfactam antibiotic BAL30072, was part of a 5-year Innovative Medicines Initiative that is funneling €50.7 million into the development of treatments for chronic lung infections in patients with cystic fibrosis and bronchiectasis. Novartis ($NVS) is also involved in the project.

Basilea, however, thinks its inhaled antibiotic is unlikely to make the grade, prompting it to put the program on the scrapheap before advancing as far as Phase I. BAL30072 was selected for the inhaled antibiotic project on the basis of in vitro and in vivo evidence of its activity against numerous multidrug-resistant Gram-negative bacteria, but a full review of data generated to date has led it to conclude the drug is lacking overall.

The decision marks another blow for BAL30072. An intravenous form of the antibiotic has stuttered through early-stage development for years. Basilea first tested the antibiotic in humans in 2011, at which time it was aiming to have the drug in Phase II by 2013. That target came and went. Basilea landed an $89 million contract with BARDA in 2013, leading to the initiation of a Phase I combination study the following year. Elevated liver enzyme levels limited dosing in Phase I.

With Basilea scrapping the inhaled antibiotic project and the BARDA contract ending after the initial funding period, BAL30072 appears to have run out of new avenues to pursue. But, while a door has closed on the antibiotic, another has opened for Basilea’s tumor checkpoint controller BAL101553. Having generated evidence the small molecule can penetrate brain tissue and act against tumors in the organ, Basilea is expanding its clinical development program to include glioblastoma.

The plan is to start adding patients with this form of brain cancer to an ongoing Phase I/IIa trial of an oral form of BAL101553 by the end of the year. To date, the study has enrolled patients with other types of solid tumors.

- read the release

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