THE ROCKEFELLER UNIVERSITY

Nuvig Therapeutics Secures $161 Million to Advance Novel Immunomodulatory Therapies

6 months ago

• Nuvig Therapeutics raised $161 million in a Series B round to advance its lead candidate, NVG-2089, into Phase 2 clinical trials for chronic inflammatory demyelinating polyneuropathy (CIDP). • NVG-2089 is a first-in-class recombinant Fc fragment immunomodulator designed to bind to type II Fc receptors, aiming to restore immune homeostasis without broad immunosuppression. • The funding will support clinical proof-of-concept studies for NVG-2089 and further development of Nuvig's preclinical pipeline, addressing unmet needs in autoimmune diseases. • Nuvig's approach is distinct from existing therapies like FcRn blockers, potentially offering a safer profile by modulating immune responses rather than depleting antibodies.

Novo Nordisk's $1bn Oral Weight Loss Drug Shows Promise but Raises Questions in Phase IIa Trial

8 months ago

• Novo Nordisk's monlunabant, an oral cannabinoid receptor 1 inverse agonist acquired for $1bn, demonstrated statistically significant weight loss in a Phase IIa trial but raised concerns about optimal dosing. • The 10mg dose achieved a 7.1kg weight reduction compared to 0.7kg with placebo, but higher doses showed limited additional benefit while increasing dose-dependent gastrointestinal and neuropsychiatric side effects. • Investor confidence wavered with Novo Nordisk's stock dropping over 6% following the announcement, as the company plans a Phase IIb trial next year to better determine the optimal efficacy-to-safety ratio.

Experts Highlight Key Trends and Challenges in Rare Disease Drug Development for 2024

a year ago

• The rare disease therapeutics landscape shows promising momentum in 2024, with three orphan drug approvals already achieved and approximately 50% of approved drugs targeting rare conditions. • The historic FDA approval of CRISPR gene therapy in late 2023 marks a significant milestone, with in-vivo CRISPR therapies and dual AAV gene therapy approaches showing promise for future treatments. • Clinical trial recruitment remains a major challenge for rare disease research due to small patient populations, geographic dispersion, and new FDA diversity requirements, though patient advocacy groups are helping bridge these gaps.