Mereo’s regulatory boost means little without a partner

Mereo spent much of last year battling activist investors and planning to keep the lights on – 40% of the UK developer’s staff are being culled to help cash last into 2026 – so today’s update comes as a small fillip. US and EU regulators have agreed that alvelestat might win full approval on a single phase 3 trial, having completed phase 2 in alpha-1-antitrypsin deficiency-associated lung disease. The problem: a partner must be found before the pivotal study can start. The search has begun, executives said on a call today, without elaborating further. The AATD pipeline has seen activity in the past few years, though the disease has proved tough to target, and most focus on liver manifestations. Augmentation therapy is approved for those with AATD lung disease, but this is controversial and not widely reimbursed. All of which means alvelestat could attract attention; clarity on what the pivotal trial needs to look like should also help. The FDA and EMA want different primary endpoints, and Mereo expects the trial to recruit some 200 patients and last up to 18 months. Given the company's weak position long-suffering shareholders must hope that interested parties emerge quickly.

Alvelestat in AATD lung disease: proposed phase 3 design (240mg versus placebo)
Two independent primary endpoints:
FDA  Patient-reported outcome of the St George’s Respiratory Questionnaire (SGRQ); activity domain or the full score to be used*
EMA Lung density measured by CT scan ("the EMA has indicated it would accept a more relaxed Type 1 error (i.e., p<0.1)") 
Note: will not be co-primaries, and trial will not need to hit both to be deemed successful; *score developed for COPD, and Mereo will need to validate it for AATD-LD before and during the phase 3 trial. Source: Mereo press release & conference call. 

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