Roche adds Phase III trials in flu prophylaxis and diabetes, plus pediatric SMA study update

Roche's Hoffmann-La Roche unit registered two new Phase III studies and updated five previously reported trials, none yet reporting results.

• A Phase III trial is recruiting to test a single dose of baloxavir marboxil compared with placebo in the post-exposure prophylaxis of influenza virus infection with respect to symptomatic, laboratory-confirmed influenza in participants who are household contacts of participants with influenza¹. The study, called Pearlstone, is estimated to enroll 325 participants¹ across 8 sites in China.
• A Phase III, open-label study, called ENI-SPIRE-2, is not yet recruiting to compare enicepatide, a glucagon-like peptide-1/glucose-dependent insulinotropic polypeptide receptor agonist, with tirzepatide among participants with type 2 diabetes mellitus and inadequate glycemic control on oral glucose-lowering medications². Chugai Pharmaceutical is listed as a collaborator, and the primary outcome is change from baseline to Week 72 in HbA1c², with enrollment estimated at 948 participants².
• The Phase IV HINALEA 2 study of risdiplam in pediatric spinal muscular atrophy patients who plateaued or declined after gene therapy remains active but not recruiting, with 19 participants enrolled³ and a primary completion estimated for March 2028.
• The Phase I study of RO7830698 in healthy volunteers and COPD patients continues recruiting, evaluating safety, tolerability, pharmacokinetics, immunogenicity, and pharmacodynamics of single and multiple doses of RO7830698 in healthy participants and participants with chronic obstructive pulmonary disease⁴, with enrollment estimated at 104 participants.
• The Phase II inavolisib-fulvestrant study in breast cancer patients with type 2 diabetes remains in recruiting status, assessing the safety of inavolisib in combination with fulvestrant, with or without palbociclib, in participants with PIK3CA-mutated, HR+, HER2-negative ABC and type 2 diabetes⁵, with enrollment estimated at 40 participants.
• The first-in-human Phase I study of RO7821657, a CEACAM5-targeted antibody, remains not yet recruiting, with Part 1 testing the drug as monotherapy in microsatellite-stable colorectal cancer and Part 2 evaluating RO7821657 as monotherapy in non-squamous non-small cell lung cancer⁶, with enrollment estimated at 405 participants.