Relmada Therapeutics Inc. is scratching its collective chin as it sifts through data from the failed phase III study of REL-1017 in treating major depressive disorder (MDD). A higher-than-expected placebo response prompted the company to call the study’s results “paradoxical.” An analysis, Relmada said, excluding sites with “implausibly” high or low placebo responses, produced a meaningful difference between the drug and placebo. The company will have more data to work with as the NMDA receptor channel blocker is in two pivotal adjunctive studies and a long-term, open-label study of MDD, with data due by the end of the year. The stock (NASDAQ:RLMD) sagged 80% to about $6.60 a share at midday.
‘SOFA’ so good: Inotrem’s nangibotide improves organ function in phase IIb septic shock study
A phase IIb trial of nangibotide in septic shock has demonstrated preliminary signs of efficacy in a subset of biomarker-defined patients and provided its developer, Inotrem SA, with a dataset that will inform the design of a registration program for the drug. Subject to agreement from regulatory agencies, the company aims to move the triggering receptor on myeloid cells 1 (Trem-1) inhibitor into a first phase III trial in early 2024. “We should have a clearer picture by the beginning of the second next year,” CEO Sven Zimmermann told BioWorld.
Odyssey opens second chapter with $168M series B
Odyssey Therapeutics Inc. closed a hefty $168 million series B round to progress multiple small-molecule and protein-based drug discovery and development programs in autoimmune disease and cancer. The company landed with a splash last year, raising $218 million in a series A round and setting out ambitions to unleash next-generation chemistry, structural biology and computational approaches on a broad range of undrugged targets, typically upstream signaling nodes that control pathways considered to be important disease drivers. The present financing means more of the same – but it accelerates its ability to execute on its plans, founder and CEO Gary Glick told BioWorld.
Slowing deals in Q3 drop 2022 behind last two years
Biopharma deals lost speed in the third quarter and are now falling behind each of the last two years, while merger and acquisition values doubled the amount from the first half of 2022. The industry completed a total of 283 deals, including licensings, collaborations and joint ventures, in Q3. They were worth a combined value of $40.98 billion, a rise of 8.3% over the second quarter but down by 28.7% from the first quarter. This pushes 2022, which had previously been the top year for deals, behind both 2021 and 2020, with a nine-month total of $136.3 million through 1,160 deals. The value is down by 6.7% from 2021 and by 4.9% from 2020. The volume has also fallen by more than 25% in comparison with both years.
GSK posts strong results for RSV shot, as Pfizer prepares to file rival shot
GSK plc has announced results from its respiratory syncytial virus (RSV) vaccine in older people that look stronger than those from its rival, Pfizer Inc., as the race to develop a first ever vaccine against the common respiratory disease heats up. Top-line results from the phase III trial in adults ages 60 and older showed an overall vaccine efficacy of 82.6% in 12,494 patients studied. Efficacy against lower respiratory tract disease was 94.1%, while in adults ages 70 to 79 the figure was 93.8%, and stood at 94.6% in those with underlying co-morbidities.
Cabaletta acquires global rights to CD19 binder from Iaso Bio in $162M deal
Nanjing Iaso Biotherapeutics Co. Ltd. has out-licensed a fully human anti-CD19 binder to Cabaletta Bio Inc. in a deal worth up to $162 million. The agreement gives Cabaletta exclusive global rights to develop, manufacture and commercialize T-cell products directed to CD19 for the purpose of diagnosis, prevention or treatment of any human autoimmune or alloimmune indications. In turn, Iaso Bio will receive $2.5 million up front and potential preclinical, development, regulatory and sales milestone payments, plus royalties on products of the collaboration. Iaso also gained a right of first negotiation to develop and commercialize Cabaletta’s products using the binder in China.
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