In this week’s edition of Pipeline Moves, we take a look at Aslan Pharmaceutical’s completion of its Phase II/III gastric cancer trial and Regenxbio’s Phase I/II interim data in mucopolysaccharidosis type I.

We also have a variety of Phase I updates. We cover Ocular Therapeutix in open-angle glaucoma and ocular hypertension, Bayer for its inflammation asset, AnaMar in idiopathic pulmonary fibrosis and systemic sclerosis, and Menarini’s solid tumour asset felezonexor.

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Aslan Pharmaceuticals’ ASLAN001 (varlitinib) had its Likelihood of Approval (LoA) rise in gastric cancer after the completion of a Phase II/III trial. The candidate’s LoA increased by seven points to 56%.

GlobalData’s review happened on 16 February following the ClinicalTrials.gov update on 15 February. LoA is identified via GlobalData’s analysis using a combination of machine learning and its proprietary algorithm.The Phase II/III study (NCT03130790) enrolled 52 patients with first-line advanced or metastatic gastric cancer. Patients received the chemotherapy cocktail modified FOLFOX6 with either varlitinib or placebo. The trial has two coprimary endpoints investigating tumour size at week 12 at the trial’s phase II portion, and overall survival at the phase III portion. Regenxbio’s RGX-111 for mucopolysaccharidosis type I (MPS I) saw its Phase Transition Success Rate (PTSR) jump five points to 33% after interim Phase I/II data was reported. Regenxbio released interim results in a 9 February press release, and the PTSR change took effect on 11 February. PTSR is the probability, given as a percentage, of a drug progressing successfully from one development stage to the next.

The company reported data from the first five patients and has plans to expand enrollment by up to six additional patients. In the Phase I/II trial (NCT03580083), the first five patients had no reported serious drug-related AEs, in the study’s primary endpoint. As for the secondary endpoints, the study reported positive biomarker activity.

MPS I is an autosomal genetic disease characterized by cell, tissue, and organ dysfunction and is caused by a deficiency in the lysosomal enzyme alpha-L-iduronidase (IDUA). RGX-111 is a single-dose gene therapy that delivers the IDUA gene to the central nervous system, which could prevent the progression of cognitive deficits in MPS I.