Heptares Therapeutics Begins Dosing of HTL0016878 for Neurobehavioral Symptoms of Alzheimer's Disease
Heptares Therapeutics announced that the first healthy participant has been dosed with the first-in-class, selective muscarinic M4 receptor agonist HTL0016878 in a Phase 1 clinical study.
Heptares Therapeutics and Allergan are developing HTL0016878, an orally available, small molecule drug candidate with potential to treat certain neurobehavioral symptoms of Alzheimer's disease. The compound stimulates M4 receptor activity in the brain with high selectivity and offers the possibility for an improved safety profile over previous muscarinic receptor agonists, which have been associated with adverse effects elsewhere in the body leading to safety and tolerability issues.
HTL0016878 was designed by Heptares Therapeutics using its proprietary structure-based drug design platform and is the first compound, selected from a series of selective M4 agonists, to progress into clinical studies. The double-blind, randomized, first-in-human study is being conducted in the United Kingdom and will assess safety, tolerability, and pharmacokinetics of single and multiple oral doses of HTL0016878 in up to 106 healthy participants. Preliminary results are expected in the first half of 2018.
Source.“First Subject Dosed in Phase 1 Clinical Study of Novel Selective MUSCARINIC M4 Agonist in Development to Treat Major Symptoms of Alzheimer's Disease.” (2017, September 1). Retrieved October 2, 2017, from http://prn.to/2yTFTdp.
Shingrix Shingles Vaccine Recommended for U.S. Food and Drug Administration Approval
Agenus, Inc., announced that GlaxoSmithKline's (GSK) shingles vaccine candidate, Shingrix, containing Agenus' proprietary immune adjuvant, QS-21 Stimulon®, was unanimously recommended for approval by the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee.
A Biologics License Applications filed with the FDA by GSK for Shingrix for the prevention of herpes zoster (also known as shingles) in individuals 50 and older is under regulatory review. The FDA will consider the Advisory Committee vote as it reviews the application, although it is not required to follow the recommendation.
GSK's shingles vaccine candidate is not currently approved for use anywhere in the world, but QS-21 Stimulon is being evaluated in various GSK development candidates in addition to being studied in Agenus' neoantigen vaccine, AutoSynVax™, in a Phase 1 clinical trial.
Source.“GSK's Shingrix Containing Agenus' QS-21 Stimulon® Adjuvant Receives Unanimous FDA Advisory Committee Recommendation for Approval.” (2017, September 13). Retrieved October 2, 2017, from http://prn.to/2xYYIhy.