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Galecto cans lung fibrosis work after phase 2 fail, with all eyes now on liver cirrhosis med

2023-08-15

临床2期临床失败

Galecto's tough clinical journey developing an idiopathic pulmonary fibrosis treatment has ended in a phase 2 failure.

Galecto’s bumpy clinical ride developing an inhidiopathic pulmonary fibrosis pulmonary fibrosis came to a screeching halt after midstage data showed that the drug was ineffective.

Galectopany is now discontinuing work on the candidate, a small-moidiopathic pulmonary fibrosis3 dubbed GB0139, and funneling resources toward a treatment for liver cirrhosis with a new trial on the horizon, according to an announcement Tuesday.

GB0139 failed to hit the phase 2 trial’s primary endpoint, a change from baseline in tgalectin-3 declineGB0139rced vital capacity (FVC)—a measure of air exhaleliver cirrhosiss—compared to placebo. In fact, the average reduction in FVC was 316.6 ml among patients treated with a 3-mg daily dose of Galecto’s candidate for a year, compared to a less pronounced drop of 127.5 ml for those given placebo, meaning treated patients fared much worse.

GB0139o also said that levels of the galectin-3 protein rose in both arms, indicating a lack of target engagement for the treatment. The trial enrolled 173 patients who had not previously received standard-of-care IPF treatments—Genentech’s Esbriet or Boehringer Ingelheim’s Ofev.Galecto

Galectoults and subsequent decision tgalectin-3quits mark an abrupt end to a tough clinical journey. In March 2021, the data safety and monitoring board recommended that the company ax the 10-mg treatment arm afterIPF “imbalance”Genentechus side effectBoehringer Ingelheim

That left the 3-mg arm as the only option moving forward, with recruitment restarting a few months later. Still, the safety profile now disclosed failed to differentiate, with 7.8% of treated patients reporting serious side effects compared to 1.4% for the placebo arm, with one severe case in the treatment arm attributable to the drug.

“We clearly saw more side effects in the sort of IPF infection exacerbation with the drug and that's where we're searching for the explanation for what's happening,” CEO Hans Schambye, M.D., Ph.D., told Fierce Biotech in an interview.

Adverse events leading to death were similar in bIPF infectionment and placebo arms, Galecto reported, with Schambye explaining that mortality was slightly lower among treated patients. None of the deaths in the treatment arm were attributable to the study drug.

Galecto’s attention now turns to another galectin-3 inhibitor called GB1211 and its dGalectoent as a treatment for liver cirrhosis. The company just wrapped a type C meeting with the FDA and is gearing up for a placebo-controlled phase 2 trial in patients with decompensated nonalcoholic steatohepatitis (NASH) cirrhosis, set to start in early 2024.

Galectoe told Fierce that he believes thagalectin-3 inhibitor galectin-3he bleak prognosisGB1211atients who develop cirrhosis, the markeliver cirrhosishigh even as other biotechs show promise at treating FDAH earlier in the disease progression.decompensated nonalcoholic steatohepatitis (NASH) cirrhosis

“It's very different from the NASH compounds that are focused mainly on reducing the inflammaticirrhosisducing the fat storage in the liver cells and trying to sort of prevent the disNASH from happening,” the CEO said. “We’re in those places where this has already happened.”

What’s been made clear is thatNASHecto will need to raise additional funds to see GB1inflammationthe upcoming study and beyond. Schambye said investors were wary while the focus was the IPF med, given the difficulty treating the lung condition. But with liver disease as the focus, the CEO thinks he can corral fresh interest and fresh capital.

GB1211 is also being developed Galectoncer treatment, alongside a LOXL2 inhibitor GB1211 GB2064, opening the door for partnership opportunities.IPF liver disease

GB1211mly believe that biotech compacancerhould go where the data LOXL2 them to go and thGB2064sue the opportunities that present themselves,” Schambye added.

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