CNS

Atuzaginstat targets a bacteria associated with Alzheimer’s disease. The higher of two doses showed a 57% slowing in cognitive decline in the Phase II/III GAIN trial in mild to moderate patients with P. gingivalis infection confirmed by saliva test.

Lilly plans a head-to-head study of donanemab versus Biogen’s Aduhelm to see which clears amyloid plaque better and has begun a rolling BLA toward accelerated approval of the Alzheimer’s drug.

In this week's podcast edition of Five Must-Know Things: a slow start for Biogen’s Aduhelm; J&J looks to transition COVID vaccine to commercial sales; 2seventy bio spins out from bluebird bio; UCB faces bimekizumab delays; and progress and setbacks in gene therapy.

Analysts expected at least $12m in third quarter sales, but the Alzheimer’s therapy brought in just $300,000. The company says educating doctors and procuring a coverage determination from CMS – not lower pricing – are key to growth.  

The companies will seek approval for zuranolone in MDD second-half 2022 and in PPD in first-half 2023, but that also means launch will probably happen second-half 2023.

The drug showed favorable but not significant trends across secondary endpoints, and greater efficacy in slower-progressing patients and those treated earlier in the disease, in a small subpopulation.

With the virtual doors about to close on the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) meeting, Scrip takes a look at some of the highlights, including data for Merck KGaA and Sanofi’s new BTK inhibitors and research showing the impact of MS therapies on COVID-19 vaccine response.

Flexion’s Zilretta is forecast to have big market potential with the growth of osteoarthritis, and Pacira’s CEO suggested there were commercial synergies with its Iovera device.

Building upon the May 2020 acquisition of US WorldMeds, Supernus is diversifying beyond Trokendi for epilepsy and will be able to rely on its existing commercial force for CNS products.

Combining biological insights with data science, the start-up emerges from stealth mode after two years of assembling its technology platform and R&D pipeline based on internal and external know-how.

The company stopped Phase II clinical trials for TAK-994 to assess a safety signal and determine next steps for the drug, which is viewed as a key product in Takeda’s push for blockbuster revenue growth. 

The company pre-announced $136m in third quarter sales, beating analyst consensus and signaling both increased oral CGRP inhibitor market share and improved per-prescription net revenue.