Roche cuts PhII eye disease program, one day after another biotech flopped in same indication
18 Oct 2022
Collaborate
Right after NGM failed to meet the primary endpoint in a Phase II eye disease trial, one of the Big Pharmas decided to remove a mid-stage candidate from its pipeline.
The update was quiet, announced in Roche’s Q3 earnings presentation, where the Swiss pharma said it was removing HtrA1 inhibitorHtrA1 inhibitor galegenimab from its pipeline. Roche did not bring up the development in its earnings call Tuesday morning. However, a Roche spokesperson told Endpoints News Tuesday morning via email simply that:
Roche decided to stop treatment with galegenimab in the Phase 2 Gallego primary study and open label extension (OLE). The decision was made because the risk/benefit ratio was considered not supportive of further treatment of patients with galegenimab.
The Phase II GALLEGO study, which had enrolled 360 participants per clinicaltrials.gov, was slated to read out next December.
Roche still has a few options up its sleeve for geographic atrophy, or GA, which eye disease researchers attempted to treat with galegenimab. Outside of a candidate in Phase I managed by Genentech, there are two companies with which Roche has partnered: One drug, from Lineage Cell Therapeutics, is also in Phase I, and the other more advanced program is in Phase II development and formerly owned by Ionis.
Roche in-licensed the drug from Ionis earlier this year, where it will be tested not only in geographic atrophy but also in the rare kidney disease IgA nephropathy. The Big Pharma shelled out $75 million back in 2018.
Ionis hands off an antisense drug for kidney disease, giving all rights to Roche
Just yesterday, long-standing Merck partner NGM Bio failed the primary endpoint in its GA study as investors sent the stock price down more than 70%. CEO David Woodhouse told Endpoints News that the biotech was still investigating what exactly happened that caused the readout to come out the way it did.
Merck partner NGM Bio takes stock beating after PhII failure in late-stage eye disease
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Source: Endpts
David Woodhouse
Roche and NGM are not the only ones that have faced issues with geographic atrophy. Stealth BioTherapeutics’ lead drug also failed a Phase II trial earlier this year. However, the mitochondria-focused biotech believed at the time that a secondary endpoint from the study could be enough to continue development.
Even though multiple companies have faced setbacks, others are still pushing forward. Apellis Pharmaceuticals reported positive Phase III data at AAO in Chicago just a few weeks ago, showing “first direct evidence of function preservation by slowing GA growth” using the drug candidate pegcetacoplan. The drug is currently awaiting a PDUFA date of Nov. 26 as Apellis hopes to secure the first FDA-approved treatment for the indication.
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