Index Pharmaceuticals Holding AB CEO Jenny Sundqvist said liquidation of the company in the wake of phase III data with cobitolimod in moderate to severe ulcerative colitis (UC) is “one of the options that will be on the table.” Shares of the Stockholm-based firm (STO:INDEX) closed Nov. 22 at SEK0.24 (US2 cents), down SEK0.41, or 63%, on word that an independent data monitoring committee (DMC) has completed the planned dose-selection analysis, including safety review and assessment for futility, of induction Study 1 of the phase III program called Conclude, testing the Toll-like receptor 9 agonist cobitolimod. The DMC concluded that Index’s lead compound is unlikely to meet the primary endpoint, and the company said development will be stopped.
Clinical trial updates for the period of January to October 2023 saw an increase of 4.6% compared to the same time period last year. Comparatively, clinical data from January to September 2023 was up 1.79% compared to the same period last year.
Morphosys AG’s rare blood cancer treatment hit its phase III primary endpoint but missed statistical significance on a secondary endpoint, sinking the stock for the day. Top-line data from the study treating JAK inhibitor-naïve patients who have the rare blood cancer myelofibrosis showed the combination of pelabresib, a BET inhibitor, and the JAK inhibitor ruxolitinib produced a statistically significant improvement in spleen volume reduction, which was the primary endpoint.
Polaris Pharmaceuticals Inc. has submitted the first part of its rolling BLA to the FDA for lead product, ADI-PEG 20, for systemic treatment of patients with malignant pleural mesothelioma with non-epithelioid histology in combination with a platinum agent and pemetrexed. The BLA is supported by the pivotal phase III Atomic study in which pegargiminase (pegylated arginine deiminase/ADI-PEG 20) met the primary endpoint of a statistically significant improvement in overall survival and the secondary endpoint of a significant improvement in progression-free survival in patients with malignant pleural mesothelioma.
Bayer AG’s asundexian, considered one of the next generation class of anticoagulants and a potential blockbuster, has failed a phase III clinical trial in atrial fibrillation. The factor XIa inhibitor is one of three with a similar mechanism of action in late stage development by big companies.
Oxurion NV, which had spent much of 2023 scraping together funding in hopes of a positive readout for its bicyclic peptide, THR-149, in diabetic macular edema (DME), now faces a bankruptcy filing after the drug failed to best established anti-VEGF therapy aflibercept (Regeneron Pharmaceuticals Inc.) in improving vision in part B of the phase II Kalahari study.
Polaris Pharmaceuticals Inc. has submitted the first part of its rolling BLA to the FDA for lead product, ADI-PEG 20, for systemic treatment of patients with malignant pleural mesothelioma with non-epithelioid histology in combination with a platinum agent and pemetrexed. The BLA is supported by the pivotal phase III Atomic study in which pegargiminase (pegylated arginine deiminase/ADI-PEG 20) met the primary endpoint of a statistically significant improvement in overall survival and the secondary endpoint of a significant improvement in progression-free survival in patients with malignant pleural mesothelioma.
Surmodics Inc. reported positive two-year data from the SWING trial, the first-in-human study to look at the safety of its Sundance Sirolimus drug-coated balloon (DCB) when used to treat occlusive disease of the infrapopliteal arteries. Results presented at the VEITHsymposium in New York showed that the Sundance Sirolimus DCB demonstrated an excellent safety profile and achieved primary patency of 71.4% at 24 months in the per protocol analysis population.
One-year data from Xeltis AG’s first-in-human Axess vascular conduit trial showed outstanding results in patients with end stage renal disease who were deemed unsuitable for arteriovenous (AV) fistula creation. The results, presented at the VEITHsymposium in New York, showed 100% secondary patency, 78% primary assisted patency and no infections were observed in data from 20 patients implanted with the Axess conduit.
Reneo Pharmaceuticals Inc.’s last patient visit Oct. 9 in the pivotal study with mavodelpar called Stride – due to yield top-line data in December 2023 – kept interest strong in primary mitochondrial myopathy (PMM), where parties are pursuing development bids by way of assorted strategies.
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