CGRP Receptor Antagonist Platform
Our small molecule calcitonin gene-related peptide (CGRP) receptor antagonist platform comprises two product candidates that can address multiple CGRP-mediated disorders. The two lead assets, rimegepant and zavegepant, are currently in late stage clinical development for the acute and preventive treatment of migraine.
BioShin’s most advanced Phase III asset is the oral small molecule CGRP receptor antagonist rimegepant, currently marketed in the U.S. for migraine. This registrational program for acute migraine launched in China and South Korea in October 2020. If approved, rimegepant will be the first innovative treatment for migraine in China in many years. BioShin also plans to advance a second CGRP-receptor antagonist, zavegepant, to treat migraine in 2022.
CGRP targeting medicines have drastically changed the way migraine is treated in amrkets where the drugs are approved. In China, this represents a significant opportunity for BioShin to change the treatment algorithm. Currently, triptans are the primary acute therapies available to the 90 million patients who suffer from migraine. As many patients do not respond to, or cannot tolerate, triptan therapies, only about 5 million or about 5% receive treatment. After approvals early in 2020 in the U.S. the small-molecule oral agents grew faster in 2020 than other injectable agents with similar mechanism of action, and BioShin anticipates that with the increased clinical trial activity for all CGRP targeting agents, oral rimegepant will be in a strong market-making position.
Rimegepant was launched in the U.S. in March 2020 as Nurtec ODT™ by BioShin’s strategic partner Biohaven Pharmaceuticals Inc. In Europe, rimegepant has been also submitted and accepted for review by the European Medicines Agency for a dual-acting (acute and prevention) indication for treatment of migraine, and it was recently approved in Israel and the United Arab Emirates.
Zavegepant is next-generation small molecule CGRP-receptor antagonist that is structurally distinct from rimegepant, with chemical properties that make it potentially suitable for multiple routes of delivery. Currently in Phase II/III trials for acute and preventive migraine in the U.S., BioShin is currently exploring various development opportunities for zavegepant in China, including for the treatment of acute migraine.
BioShin has an aggressive plan to advance its CGRP-receptor antagonist medicines into a range of CGRP-mediated diseases.
Currently there are ongoing phase II proof-of-concept studies to assess rimegepant for the treatment of plaque psoriasis and trigeminal neuralgia. Another rimegepant phase II study for the treatment of acute post-traumatic head injury will start in the second half of this year. Plans are underway to consider additional CGRP-mediated indications, ranging from head pain to chronic pelvic pain, and in CGRP-mediated atopic diseases, such as asthma where zavegepant is being advanced to a Phase Ib study in the third quarter of this year.
CGRP Platform Product Candidates