Clinical Daily Summary: What Happened on October 21, 2026

Tezspire meets both Phase III endpoints in eosinophilic esophagitis

Tezspire met both primary endpoints at week 24 in the Phase III CROSSING trial, according to Amgen and AstraZeneca. Improvements continued through week 52.1 The randomized, double-blind trial enrolled 368 people aged 12 to 80 who could continue stable background treatment.1

At week 24, tissue remission occurred in 64.8% of participants on 210 mg and 68.9% on 420 mg, compared with 3.5% on placebo.1 Swallowing-symptom scores fell by 18.8 and 22 points, respectively, versus 14.7 points with placebo.1

At week 52, remission rates were 67.8% and 63.3% for the two doses, compared with 5.4% for placebo.1 The companies also reported total endoscopic remission in 34.4% and 29.5% of treated participants, versus 4.1% on placebo.1 The safety profile was consistent with Tezspire’s approved uses. Diarrhea, headache, and nasopharyngitis were among the most common adverse events.1

Olorofim follow-up adds day-84 outcomes after earlier non-inferiority result

Shionogi and F2G reported additional Phase III OASIS findings for olorofim in 225 adults with invasive aspergillosis resistant to azole treatment or unsuitable for it.2 The results add longer-term mortality, response, safety, and hospital-discharge measures to the previously reported day-42 primary result.2

At day 84, all-cause mortality was 32.5% with olorofim and 29.7% with the comparator, AmBisome plus standard care.2 Global response rates were 30.5% and 28.4% at day 84, compared with 26.5% and 31.1% at day 42.2 At day 42, mortality was 23.8% with olorofim and 24.3% with the comparator, meeting the trial’s non-inferiority endpoint.2

At least one drug-related adverse event occurred in 35.8% of olorofim recipients and 63.9% of comparator recipients. Renal adverse events were less frequent with olorofim, while drug-induced liver injury was similar.2 Patients receiving olorofim also left the hospital earlier, according to the reported findings.2 The new results are scheduled for presentation at IDWeek on October 22 and submission to the FDA, European Medicines Agency, and Asian regulators.2 The FDA sent a complete response letter on the application in June 2023, requesting additional data and analyses before it could approve the drug.2

Claris reports early visual gains with CSB-001 in limbal stem cell deficiency

In an open-label proof-of-concept study, 41.4% of eyes treated with Claris Biotherapeutics’ CSB-001 gained at least 15 visual-acuity letters by week 20, compared with none of the untreated control eyes.3 The study included 49 eyes from 39 participants, with 29 eyes receiving treatment and 20 serving as controls.3

CSB-001 is an eye-drop solution containing recombinant human deleted hepatocyte growth factor. It was given four times daily across two eight-week treatment periods separated by a one-month break.3 At least 10 letters of improvement occurred in 55.2% of treated eyes and 5% of control eyes.3

Claris said gains persisted after dosing stopped, with 50% of treated eyes retaining improvements of at least 15 letters and 81% retaining gains of at least 10 letters for 16 weeks.3 The company described CSB-001 as generally safe and well tolerated. It plans to start two pivotal studies in the first half of 2027, enrolling about 400 participants.3

Also worth knowing

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  AstraZeneca and Oracle signed a non-binding agreement to explore AI and real-world data for trial recruitment, initially across several disease areas. A planned first program would support hypertension care and research in Abu Dhabi with M42.45

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  A study reported that women taking CagriSema lost 25% of their body weight.6

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