CGRP

• Atogepant (brand name: Aquipta) was recently recommended by the National Institute for Health and Care Excellence (Nice) to prevent episodic and chronic migraine attacks.
• The drug would be recommended to people who have at least four migraine days a month or where at least three previous preventative treatments have failed.
• Migraine is a complex neurological condition that affects about 10 million people in the UK.
• It’s characterised by recurrent, severe headaches that can be made worse by physical activity and are often debilitating.
• However, it’s only suited to patients who suffer from episodic migraines – whereas atogepant can be used by people who have both chronic and episodic migraines.

Consistently effective

Three clinical trials have shown atogepant to be safe and effective for people with episodic or chronic migraines.

• The Advance trial evaluated how safe and effective different doses of atogepant were compared with a placebo in preventing episodic migraine.
• The 60mg once-daily tablet was found to be well tolerated and effective, leading to nearly seven fewer migraine days per month.
• A third trial, the 302-LTS trial, followed participants who suffered from episodic migraine for over a year, finding that atogepant was consistently effective for reducing migraine attacks.
• Atogenpant was consistently shown to be safe across all studies, including the one that lasted for a year.

Anna Andreou receives funding from the Medical Research Foundation and Brain Research UK. She also received research funding from eNeura, AbbVie and Pfizer. She is affiliated with the International Headache Society, being elected as a Trustee of the Board. She is Chair of the Headache special interest group of the British Pain Society.

• A recent market research study (n=150) of Neurologists, Headache Specialists and Primary Care Physicians revealed that 93% of clinicians treating migraine have moderate to extremely high unmet needs for alternatives to triptan therapy.2 Clinicians stated their desire for fast and safe alternatives for two large pools of acute migraine patients – those who have an insufficient response to triptan therapy, and those who have contraindications to triptan use.
• ELYXYB’s product profile mapped with a high degree of certainty to these stated unmet needs.
• In clinical studies, patients treated with ELYXYB® demonstrated pain relief in as little as 15 minutes, and significant pain relief compared to placebo within 45 minutes in nearly 50% of patients.
• Approximately 34% of patients were pain free at two hours.3 Notably, these data are well differentiated from two other new oral migraine medications of a different class, calcitonin gene-related peptide (CGRP) receptor antagonists.

• A total of 88 patients were enrolled in this multi-site study in the U.S. Topline results are expected in early December 2023.
• Tonix believes that by engaging and activating oxytocin receptors in the trigeminal ganglia, TNX-1900 has the potential to help those suffering from chronic migraine.
• “TNX-1900 is being developed as a novel, non-CGRP antagonist approach to treatment for chronic migraineurs,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals.
• “We would like to thank the participants, their families, and all the investigators and researchers who have been an important part of this journey so far.”

• Now with the July commercial availability of Zavzpret, Spherix has begun tracking its launch in the Launch Dynamix™: Zavzpret for Acute Treatment of Migraine study.
• As of June, over three-quarters of physicians planned to prescribe Zavzpret to their migraine patients within the first six months of availability.
• One way to tease apart the relative advantages and disadvantages of new migraine therapies is to utilize Spherix’s Launch Dynamix™: Zavzpret series.
• Spherix will be tracking the awareness and perception of these investigational, pipeline therapies in its separate service, RealTime Dynamix™.