Today, the FDA granted traditional approved to lecanemab (branded as Leqembi), a monoclonal antibody from Eisai and Biogen for adult patients with Alzheimer’s disease. The agency made the decision on the basis of a confirmatory trial that showed its clinical benefit. The drug, which reduces the formation of amyloid plaques in the brain, is the…
Delix Therapeutics launches phase 1 study for novel neuroplasticity-promoting therapeutic
Boston-based Delix Therapeutics has won regulatory approval to commence a study of the non-hallucinogenic psychoplastogen DLX-001. Psychoplastogens are a class of drugs that have the potential to promote neuroplasticity, which refers to the brain’s ability to adapt and form new connections between neurons. That capability could enable improvements in conditions such as depression, anxiety and…
QRL-201, a novel therapy targeting STMN2 expression, enters phase 1 ALS trial
Cambridge, Massachusetts-based QurAlis has dosed the first patient with the biotherapeutic QRL-201 in a Phase 1 clinical trial (ANQUR) in Canada. QRL-201 is a novel therapy targeting the restoration of STATHMIN-2 (STMN2) expression in amyotrophic lateral sclerosis (ALS) patients. QurAlis believes ANQUR the first study to evaluate such a treatment. Stathmin-2 (STMN2), also known as…
Walgreens announces clinical trial offerings
The drug store giant Walgreens (Nasdaq:WBA) has launched a clinical trial business aimed at optimizing patient experience, recruitment and clinical trial diversity. Deerfield, Illinois–headquartered Walgreens will offer both in-person and virtual care clinical trial options. In a press release, Walgreens underscored FDA’s push to improve racial and ethnic diversity in clinical studies. In 2020, three-fourths…
Axogen announces positive topline data from Phase 3 nerve graft study
Focused on developing peripheral nerve regeneration and repair products, Axogen (Nasdaq:AXGN) announced that the Phase 3 RECON study met its primary endpoint in comparing its Avance nerve graft to conduits in digital nerve injuries. The primary endpoint was the return of sensory function based on static two-point discrimination. This test measures the ability to detect…
The COVID-19 effect: Research platforms require new capabilities
Like a Category 5 hurricane, COVID-19 has uprooted traditional clinical trial methods to clear space for emerging models and practices to grow and flourish. Three related and complementary trends will have a profound and lasting impact. The shift to virtual/decentralized clinical trials. The popularity of decentralized clinical trials (DCTs) skyrocketed following the nationwide lockdown last March.…
Is J&J’s COVID-19 vaccine linked to tinnitus?
In Johnson & Johnson’s (NYSE:JNJ) Phase 3 trial for the Ad26.COV2.S COVID-19 vaccine, six vaccine recipients developed tinnitus or ringing in the ears. In five of those individuals, tinnitus had either resolved or was resolving. The condition was unresolved in the other trial volunteer. No placebo recipients developed the condition. J&J concluded that the tinnitus reports…