RedHill drops phase 3 lung disease program amid 'negative sector sentiment'

Hoping to lighten its load, RedHill Biopharma has thrown a phase 3 lung disease program from its pack in an attempt to conserve resources and carry its COVID-19 med to the top.

The Israel-based company has abandoned its late-stage trial of RHB-204, an investigational oral drug designed to treat lung disease tied to nontuberculous mycobacteria (NTM). The common group of bacteria can cause serious infection in a small number of people—most often the immunocompromised. There currently aren’t any singular, first-line therapies available for the condition.

The trial discontinuation is due to slow patient enrollment, the current state of the financial markets and “the negative biotech sector sentiment,” Gilead Raday, RedHill's chief operating officer and head of R&D, said in a May 22 release.

RHB-204 had already picked up both fast-track and orphan drug designations from the FDA for NTM. Despite this, RedHill would rather seek an out-licensing partner to take on the asset, which is also being assessed in a phase 3 trial for a serious lung disease known as pulmonary mycobacterium avium complex disease.

Though RedHill has lightened its load to better funnel its resources to other programs, the company said it is still welcoming “revenue-generating product acquisition.”

But for now, the company is prioritizing RHB-107, also known as upamostat, a once-daily oral medicine for non-hospitalized COVID-19 patients. In a small phase 2/3 trial, the antiviral staved off hospitalization in all 41 patients with symptomatic COVID-19 in the phase 2 portion.

That trial is RedHill’s second attempt at pushing a COVID-19 pill through phase 2 after a previous asset flopped in the same indication. The company is also evaluating RHB-107 as a treatment for several cancers and inflammatory gastrointestinal diseases.

RedHill’s most advanced clinical asset is opaganib, an SK2 inhibitor for acute radiation syndrome and other indications. The biotech also has a few other candidates in late-stage clinical development, including RHB-104 for Crohn’s disease and RHB-102 for gastroenteritis.

The organization already has two approved products in the form of Talicia for H. pylori infection and Aemcolo for E. coli-induced diarrhea.   

"We must focus our limited resources where we believe most value can be generated for our shareholders in the short to medium term,” Raday said.

The company shared similar sentiments last summer when it shed staff in hopes of saving money.