Sosei Group Corp.’s wholly owned subsidiary Heptares Therapeutics, of London, dosed the first healthy subject in its phase I trial testing HTL-0016878, a muscarinic M4 receptor agonist. The start of the phase I trial triggers a $15 million milestone payment from Allergan plc, of Dublin, under their 2016 partnership. Preliminary safety, tolerability and pharmacokinetics of single and multiple oral doses of HTL-0016878 in the 106-subject trial are expected in the first half of 2018. The companies eventually plan to test the drug as a treatment for neurobehavioral symptoms in Alzheimer’s disease patients.
Mediwound Ltd., of Yavne, Israel, reported top-line results from the second cohort of its phase II trial testing Escharex for debridement of dead or damaged tissue in diabetic foot ulcers and venous leg ulcers. Vital signs, pain scores, infection rates, laboratory parameters and blood loss were comparable among the 38 patients treated with either Escharex or the hydrogel vehicle. Based on those data and positive efficacy data from the first cohort, Mediwound plans to start a phase III pivotal program in the first half of 2018.
Progenics Pharmaceuticals Inc., of New York, reported additional clinical data from its phase IIb trial testing Azedra (iobenguane I 131) in patients with malignant, recurrent or unresectable pheochromocytoma and paraganglioma at the 5th International Symposium on Pheochromocytoma and Paraganglioma in Sydney. In the entire study population, median overall survival, as of the March 10 cutoff, was 36.7 months from the first dose of Azedra, a radiotherapeutic. Patients who received two doses of Azedra had a median overall survival of 48.73 months, compared to 17.42 months among patients who received only one dose. Separately, Progenics said that it requires more time to complete its NDA submission for Azedra to give its manufacturer time to prepare for pre-approval inspection by the FDA, which could take eight to 12 weeks. Progenics has completed its rolling submission of the NDA except for the notification of pre-approval inspection readiness.