Valiloxybate

Plus, news about Congruence Therapeutics, Artelo Biosciences, Ashvattha Therapeutics, Biocytogen and AL-S Pharma: 💤 Avadel licenses sleep drug for $20M upfront: Avadel will develop and sell XWPharma’s valiloxybate, a GABA-B agonist, for disorders including narcolepsy and idiopathic hypersomnia (IH) worldwide, excluding mainland China, Hong Kong, and Macau. XWPharma could get development milestone payments of up to $30 million, plus $155 million on valiloxybate’s annual sales up to $750 million. For each year’s sales between $750 million and $3.5 billion, Avadel will pay XWPharma 10% of those sales. Avadel will also pay royalties up to the mid-teens, plus an additional $10 million after the first commercial sale in the US for each indication beyond narcolepsy and IH. The drug is an extended-release, salt-free form of oxybate that could enter pharmacokinetic trials this year. Avadel sells a similar long-acting drug, sodium oxybate, as Lumryz, and is engaged in a long-running legal battle with Jazz Pharmaceuticals, which alleges that Lumryz infringes Jazz’s IP on its drug Xyrem. — Elizabeth Cairns 💰 Congruence Therapeutics gets $32M for hot obesity target: The Montreal-based biotech raised the money from Amplitude Ventures, OrbiMed and others. The funding is expected to get the biotech through a Phase 1b readout in MC4R-deficient genetic obesity. The company plans to ask for clinical trial clearance of CGX-926 by the end of this year. MC4R has become an increasingly popular target for drug developers working on obesity and cachexia because of its human genetics validation. — Kyle LaHucik 🧪 Artelo Biosciences details Phase 2 data in cancer cachexia: The California biotech shared interim data from fewer than 20 patients in a mid-stage study of ART27.13. The cannabinoid receptor agonist is being evaluated for cancer anorexia-cachexia syndrome. Cachexia leads to appetite and weight loss in addition to muscle weakness in as many as 80% of cancer patients, according to Artelo. There are no FDA-approved treatments for the condition. Pfizer is also working on a GDF15 program for cancer cachexia, with a Phase 3 trial underway as of August. Some companies are considering MC4R as a target for cachexia. Artelo said the interim data are a “catalyst for advancing discussions with pharmaceutical companies” regarding its drug. — Kyle LaHucik 👁 Ashvattha Therapeutics’ Phase 2 ophthalmic data: The California biotech said migaldendranib reduced the average number of yearly intravitreal injections from 8.4 to 1.6 in patients with wet age-related macular degeneration and diabetic macular edema. Ashvattha secured up to $50 million in a Series B extension earlier this year to help bankroll the mid-stage trial. — Ayisha Sharma 🖋 Biocytogen inks antibody deal with Merck KGaA : The Beijing-based biotech will work with the pharma giant to advance “antibody-conjugated lipid-based delivery solutions for nucleic acid payloads” with the help of Biocytogen’s RenMice platform. Merck has been granted an exclusive option to license antibody assets developed under the collaboration. Financial terms of the deal were not disclosed. — Ayisha Sharma 🧬 AL-S Pharma’s Phase 2 ALS data: The Zurich-based biotech said AP-101 produced “clinically meaningful” changes for 73 patients with ALS, 21 of whom had a mutation of the SOD1 gene. The biotech did not report specific data figures, but said the changes were seen in measures “related to survival and non-invasive ventilation as well as stabilization of clinical disease-staging and neurofilament biomarkers.” AL-S tracked patients for one year. — Max Gelman