Draig Therapeutics Ltd. launched with a $140 million series A and an AMPA receptor modulator program that has completed phase I and will start a phase II trial in major depressive disorder later in 2025. The series A also will enable the company to advance two small-molecule GABA receptor modulators that have the potential to treat a range of neuropsychiatric disorders, into the clinic in 2026.
The Alphafold machine learning system for predicting a protein’s structure from its amino acid sequence has been adapted to make it possible to design de novo proteins that fold in a particular way and bind to prespecified target proteins. The sister system, called Alphadesign, works by generating random strings of amino acids, using Alphafold to predict their structure, and then iteratively optimizing the design.
The U.K. government has announced the latest measures to speed up and expand clinical trials, launching Be Part of Research, a central national register where people can search and sign up to take part in studies.
As it prepares to present the latest data from the phase I/II clinical trial of EO-2463, Enterome SA has secured $19 million to expand and complete the study, and to scope phase III development of the microbiome-derived off-the-shelf immunotherapy in the treatment of non-Hodgkin lymphoma.
Newco Elkedonia SAS has raised €11 million (US$12.7 million) in a seed round, which will fund it to take a potentially first-in-class ELK-1 inhibitor into the clinic in the treatment of refractory depression. ELK-1 plays a pivotal role in neuroplasticity and in reward circuits in the brain, which when disrupted can lead to depression, addiction and post-traumatic stress disorder.
Newco Elkedonia SAS has raised €11 million (US$12.7 million) in a seed round, which will fund it to take a potentially first-in-class ELK-1 inhibitor into the clinic in the treatment of refractory depression. ELK-1 plays a pivotal role in neuroplasticity and in reward circuits in the brain, which when disrupted can lead to depression, addiction and post-traumatic stress disorder.
The U.K. government has doubled the rate that pharmaceutical companies must repay on sales of branded drugs, under the statutory rebate scheme, to a record 31.3%. Only 1-2% of total sales of branded drugs fall under the statutory scheme, but the increase is seen as a sign that an ongoing review of the voluntary scheme is not going well.
Three months after dosing the first patient with its dual vector gene therapy, Splicebio SL has closed a $135 million series B to fund the phase I/II trial of SB-007 in the treatment of Stargardt’s disease to completion. Other adeno-associated viru gene therapies for the inherited retinal disorder have entered the clinic, but SB-007 is the first with the capacity to deliver a full version of the ABCA4 gene that underlies Stargardt’s.
The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has issued its first official guidance on how to develop bacteriophages as licensed medicinal products. This covers personalized phage therapies designed for specific patients – at present the only form in which they are available – but also is relevant to the development of off-the-shelf products for treating common infections.
The EMA’s safety committee has issued a warning that the GLP-1 receptor agonist Ozempic (semaglutide, Novo Nordisk A/S) can cause an acute eye condition in which the optic nerve is damaged by a sudden loss of blood supply. After reviewing several large epidemiological studies, clinical trial and in-market data, EMA’s Pharmacovigilance Risk Assessment Committee has concluded non-anterior ischemic optic neuropathy is a “very rare” side effect of Ozempic, that “may affect up to one in 10,000 people taking semaglutide.
