Selecta Biosciences Inc. and partner Swedish Orphan Biovitrum AB rolled out top-line phase III data from the Dissolve I and II trials testing SEL-212 in adult patients with chronic refractory gout. Dissolve I met its primary endpoint, with 56% of patients given monthly doses of the drug at 0.15 mg/kg achieving a response, defined as reaching and keeping reduction in serum urate <6mg/dL for at least 80% of the time during the sixth month. Dissolve II rang the bell, too, with 47% of those who got monthly doses of SEL-212 at 0.15 mg/kg achieving a response. SEL-212 is a combination of Selecta’s ImmTOR immune tolerance platform and pegadricase, a therapeutic uricase enzyme. Shares of Selecta (NASDAQ:SELB) were trading midday at $1.27, down 1.5 cents, or 1.2%.

Mereo’s restructuring leads to a potential approval path for alvelestat

Mereo Biopharma Group plc’s path to approval for alvelestat is a phase III study that would preclude an additional confirmatory trial. After meetings with the U.S. FDA and the EMA, Mereo said it is designing a 12- to 18-month, global phase III trial of the neutrophil elastase inhibitor for alpha-1-antitrypsin deficiency-associated lung disease. The company said also that it is looking for a partner to fund the clinical trial. The company reduced its headcount by 40% and significantly reduced its other expenses starting in October 2022 to get this far. Mereo’s stock (NASDAQ:MREO) reacted well to the phase III plan by trading 13% upward to about 84 cents per share at midday.

Implementation of EU diagnostics reg forcing drug trial delays

The dominoes are falling on European clinical trials as the unintended consequences of the EU’s In Vitro Diagnostics Regulation take hold. Last year’s implementation of the regulation has resulted in the delay of up to 160 drug trials to date with as many as 420 trials expected to be delayed over the next three years, according to a survey conducted by the European Federation of Pharmaceutical Industries and Associations (EFPIA). Consequently, more than 40,000 patients in Europe, about half of whom have cancer, could have delayed access to clinical trials over the next few years, the European biopharma trade association said.

Newco news: Likang cleared for China’s first clinical trial testing personalized neoantigen-targeted cancer vaccine

Likang Life Sciences Holdings Ltd. received approval from China’s NMPA to start a clinical trial of its candidate, LK-101 injection, for advanced solid tumors. The company claims this is the first personalized neoantigen vaccine and mRNA editing product that is approved to enter the clinical stage in China.

Also in the news

Abbvie, Akoya, Alexion, Algernon, Allarity, Alpine Immune, Ankyra, Apie, Aquavit, Arcutis, Arrowhead, Avicanna, Aviceda, Beam, Beigene, Clarivoyant, Connect, Cytovation, Decibel, Devshealth, Disc, Enlivex, Enveric, Evofem, Fore, Galderma, Gamida Cell, Incyte, Ingenū, Inmagene, Kangpu, Karuna, Leo, Lucy Scientific, Newron, Nextpoint, Nimbus, Orsobio, Oxurion, Pharvaris, Psyence, Quralis, Rayzebio, Regeneron, Revive, Roche, Scilex, Sonata, Sun, Takeda, UCB, Vaccitech, Vaxxinity, Wesana Health, Wugen, Xalud, Zura