Frontier Biotech's COVID-19 Drug FB2001 Advances to Phase II/III Trials; Pfizer's Migraine Drug Rimegepant Approved in the EU

According to announcements from various companies, Frontier Biotech's COVID-19 small molecule drug FB2001 has been approved for Phase II/III international multicenter clinical trials, and Pfizer's migraine drug rimegepant, which was acquired for $1.24 billion, has been launched in the EU!

Frontier Biotech: Small Molecule COVID-19 Drug FB2001 Approved for Phase II/III International Multicenter Clinical Trial

According to the announcement by Frontier Biotech, the critical international multi-center Phase II/III clinical trial of FB2001, an anti-COVID-19 3CL protease inhibitor developed in collaboration by Frontier Biopharmaceuticals, Shanghai Institute of Materia Medica of the Chinese Academy of Sciences, and Wuhan Institute of Virology of the Chinese Academy of Sciences, has been approved by the National Medical Products Administration.

This is an international, multicenter, randomized, double-blind, placebo-controlled Phase II/III clinical study evaluating the efficacy and safety of FB2001 in hospitalized patients with COVID-19.

FB2001 is an injectable SARS-CoV-2 protease inhibitor intended for the treatment of hospitalized COVID-19 patients. Studies have shown that FB2001 exhibits potent and broad-spectrum inhibitory activity against major circulating SARS-CoV-2 variants, including Alpha, Beta, Delta, and Omicron. The IC₅₀ value of FB2001 for inhibiting the 3CL protease of SARS-CoV-2 is 0.053±0.005μM. These research findings have been published in the prestigious international journal *Science*.

The drug concentration of FB2001 alone in the human body has reached the predicted effective dose, without the need for combination with pharmacokinetic enhancers (such as ritonavir, etc.), which can reduce the potential risk of drug interactions caused by the use of pharmacokinetic enhancers.

Pfizer: New Migraine Drug Introduced for $1.24 Billion Launches in the EU

Pfizer announced that the marketing application for rimegepant (trade name: Vydura) has been approved by the European Union for the treatment of acute migraine and prevention of episodic migraine. This is the first drug approved by the EU for both acute and preventive treatment of migraine.

Rimegepant, developed by Biohaven, is a small-molecule oral calcitonin gene-related peptide (CGRP) receptor antagonist that treats migraines by reversibly blocking the CGRP receptor and inhibiting the biological activity of endogenous CGRP neuropeptides. As an orally disintegrating tablet (ODT), rimegepant dissolves quickly in the mouth without water (or with only a small amount of water), offering advantages such as convenient administration, rapid absorption, high bioavailability, and minimal irritation to the gastrointestinal mucosa.

On November 9, 2021, Pfizer and Biohaven reached an agreement on the two migraine drugs rimegepant and zavegepant, granting Pfizer commercial rights outside the United States. The total value of the deal reached $1.24 billion, including a $500 million upfront payment and $740 million in milestone payments.

The migraine drug Rimegepant was approved by the U.S. FDA in March 2020 and is also the first CGRP receptor antagonist approved by the U.S. FDA in ODT form. This approval in Europe is based on Phase III trial data of Rimegepant, which can relieve acute migraines in as fast as 2 hours compared to placebo, providing lasting efficacy for up to 48 hours for many patients without being addictive.

Editor: Qijin

Disclaimer: This article is a compilation of content from the PharmNet website and does not represent the views of this platform. If there are any issues involving the content, copyright, or other matters, please contact us through the message board of this official account, and we will delete the content as soon as possible.