WHO endorses GSK's dolutegravir for HIV; Syapse collaborates with Pfizer on RWE
→ GSK is getting a big endorsement from the World Health Organization. The WHO is recommending that their drug dolutegravir (DTG) should be the standard therapy in frontline and second-line settings for HIV patients in updated 2019 guidelines. They note: “DTG is a drug that is more effective, easier to take and has fewer side effects than alternative drugs that are currently used. DTG also has a high genetic barrier to developing drug resistance, which is important given the rising trend of resistance to EFV and nevirapine-based regimens. In 2019, 12 out of 18 countries surveyed by WHO reported pre-treatment drug resistance levels exceeding the recommended threshold of 10%.”
→ San Francisco-based Syapse inked a strategic collaboration with Pfizer focused on real-world evidence. “This collaboration will initially focus on the molecular testing and therapy choices on precision oncology journeys in the healthcare system setting,” according to the companies.
→ ArunA Bio has bagged another $13 million to fine tune its neural exosome delivery platform in hopes of finding new treatments for ALS and Huntington’s disease. The proceeds, provided by Eshelman Ventures as well as other institutional investors and company insiders, will help fund work leading up to an IND.
→ In the latest extension of Regulus’ struggles, the FDA has formalized a voluntary partial hold it placed on a Phase I study of RGLS4326. Regulators now want to see more nonclinical data regarding chronic toxicity before the company can resume the multiple ascending dose portion of the trial for autosomal dominant polycystic kidney disease. The requested information will involve studies in both mice and non-human primates.