Clinical Trial News

Gram-negative bacterial resistance in the U.S. is rising, complicating UTI treatment. Oral carbapenems like tebipenem and sulopenem offer broad-spectrum activity but face FDA hurdles. Tebipenem HBr showed promise in trials but failed FDA's micro-ITT analysis. Sulopenem's trials missed endpoints, delaying its approval. Oral carbapenems could revolutionize UTI management but raise resistance concerns.

A study reveals genetic variations in serotonin receptors affect psychedelic drug potency, suggesting genetics should influence clinical trials for their therapeutic use. Different gene forms of the 5-HT2A receptor showed varied responses to psychedelics, indicating genetics play a role in individual sensitivity to these drugs.

Sutro Biopharma, in collaboration with Merck, dosed the first patient in a Phase 1 study for a novel cytokine derivative therapeutic targeting cancer, triggering a $10 million payment to Sutro. This milestone highlights the synergy between Merck's immuno-oncology expertise and Sutro's biologics engineering capabilities.

A 12-month study on glaucoma patients using a weekly visual field telemedicine (VFTM) app showed 75% compliance with weekly testing and 65% test reliability at home, lower than in-clinic tests (85%). VFTM detected clinical progression in two eyes, demonstrating good concordance with in-clinic results, supporting its use for monitoring between visits.

Spectral Medical Inc. updates on Tigris trial for PMX hemoperfusion in septic shock treatment, showing positive outcomes. 40 patients randomized, 14 sites active. PMX aims to reduce 28-day mortality, with potential FDA approval. Spectral also advances renal replacement therapy platforms.

Retifanlimab, a PD-1 inhibitor, showed clinically meaningful antitumor activity in patients with platinum-refractory squamous carcinoma of the anal canal (SCAC), with an ORR of 13.8% and stable disease in 35.1%, achieving a DCR of 48.9%. Responses were durable, with a median DOR of 9.5 months, and the safety profile was consistent with PD-(L)1 inhibitors.

Sequana Medical's alfapump pivotal study, POSEIDON, for recurrent or refractory ascites due to liver cirrhosis, received FDA IDE approval, enabling a U.S. launch by H1 2022. The study, involving up to 50 patients, aims to reduce therapeutic paracentesis frequency, with CMS's proposed NTAP pathway changes potentially benefiting the alfapump.

Eisai announced FDA accepted the Biologics License Application for lecanemab, an anti-amyloid beta antibody for early Alzheimer's treatment, under accelerated approval. A Phase 3 trial's results, expected Fall 2022, may confirm its clinical benefit. Eisai aims for traditional approval by Q1 2023, with BioArctic receiving a MEUR 15 milestone payment.

Margetuximab plus chemotherapy showed improved PFS and OS over trastuzumab plus chemotherapy in ERBB2-positive advanced breast cancer, with an ICER of $1,486,442.35/QALY, exceeding WTP. However, for CD16A-158F allele carriers, ICER decreased to $592,669.73/QALY, indicating potential cost-effectiveness in this subgroup.

Novartis AG announced a positive CHMP opinion recommending marketing authorization for Scemblix (asciminib) for Ph+ CML-CP treatment in adults previously treated with two or more TKIs. The EC will review the opinion, with a decision expected soon. Scemblix, if approved, offers a new CML treatment option targeting the ABL myristoyl pocket. Additionally, the EC approved Cosentyx for new juvenile arthritis indications, based on phase III study data.