13th Jun 2019 15:49
(Alliance News) - Sareum Holdings PLC on Thursday said it has been focusing on toxicology studies in its development of drug candidates SDC-1801 and SDC-1802 with a view to CONDUCT human trials in 2020.
Both candidates are being developed internally by Sareum and are part of its development portfolio and were selected for development in September 2018. SDC-1801 is being developed as a therapy for autoimmune disease while SDC-1802 is intended to treat cancers.
Sareum's toxicology studies, which are being conducted on rodents, are intended to determine the maximum tolerated doses of both candidates. Of the two, SDC-1801 is the most advanced and has shown good tolerability as doses of as much as 30 times the level required for a good response in previous efficacy studies. So far, the maximum tolerated dose has not been reached.
Multiple studies are now ongoing to find the doses for specific toxicology studies and are expects to be part of Sareum's applications for initial human trials.
Sareum is also looking to find "robust manufacturing routes" to produce each candidate drug for study use. So far, a manufacturing route for SDC-1801 has been developed while SDC-1802's search is ongoing.
Chief Executive Tim Mitchell said he is "convinced SDC-1801 and SDC-1802 represent strong and well-differentiated candidates" as treatments for cancer and autoimmune diseases.
"We are focused on advancing these exciting preclinical candidates towards human trials as quickly as possible, aiming for first-in-man studies to begin in 2020," said Mitchell.
Mitchell also commented on SRA737, the third drug in Sareum's active development portfolio and currently out-licenced to Sierra Oncology. SRA737 is currently being developed as a treatment for anogenital cancers, where there are currently no second-line therapies once chemotherapy stops working.
"Sierra has proposed a registration-intent phase 2 trial as a route to market in anogenital cancers for this exciting prospect, with potential for accelerated approval and payments due to Sareum linked to the achievement of certain milestones. Registration-intent phase 2 trials represent an efficient approach to accelerate time to market for drugs intended to treat life-threatening diseases where no effective treatment exists," the CEO said.
"Both Sierra and Sareum believe that SRA737 is competitively positioned as potentially one of the leading clinical assets in its class. In both trials, the treatments were safe and well tolerated, with the majority of adverse events being only mild or moderate," he added.
Shares in Sareum were up 1.0% at 0.53 pence on Thursday afternoon in London.
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