- LianBio reported that its partner BridgeBio Pharma Inc informed LianBio that Helsinn Healthcare SA, which holds the Truseltiq (infigratinib) New Drug Application (NDA) in the U.S., is permanently discontinuing distribution of the drug.
- It also anticipates requesting the withdrawal of the NDA in the U.S. due to business reasons.
- Due to the planned withdrawal of the NDA, BridgeBio informed LianBio that it intends to close the ongoing global Phase 3 PROOF-301 clinical trial of infigratinib in first-line cholangiocarcinoma (CCA).
- Consequently, LianBio is terminating activities related to the PROOF-301 trial in China and no longer plans to pursue developing and commercializing infigratinib in CCA indications in its licensed territories.
- LianBio intends to continue supporting patients currently being treated with infigratinib in China under the special Named Patient Program in Hainan Province.
- LianBio expects to continue the ongoing Phase 2a proof of concept trial of infigratinib in patients with locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma.
- Otonomy Inc announced that the clinical evaluation of higher doses for OTO-413 (0.75 mg and 1.50 mg) in patients with hearing loss demonstrated no clinically meaningful improvement.
- These results contrast the positive clinical signal observed with 0.3 mg OTO-413 versus placebo in the previous Phase 1/2 and Phase 2a trial cohorts using the same study design and endpoints.
- "The lack of clinical activity for OTO-413 in these higher dose cohorts is disappointing and unexpected based on our in vivo preclinical studies, which supported a broad therapeutic dose range for OTO-413. However, our ex vivo studies and data in the neurotrophin literature suggest the possibility of a complex dose-response relationship for BDNF with declining activity observed at higher dose levels, which might explain these results," said Alan C. Foster, Ph.D., chief scientific officer of Otonomy.
- Initial clinical studies have demonstrated that a single intratympanic injection of OTO-413 is well-tolerated and improves hearing function across multiple clinically validated speech-in-noise hearing tests.
