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CHICAGO — November 3, 2022 — Emalex Biosciences announced the closing of an upsized and oversubscribed $250 million Series D funding round that will fund a Phase 3 clinical trial and potential commercialization of a new class of drug for patients with Tourette Syndrome. '
Bain Capital Life Sciences led the funding round with participation from Paragon Biosciences, Valor Equity Partners, Fidelity Management & Research Compnay and several family offices.
Emalex’s Phase 3 clinical trial for its investigational first-in-class new drug ecopipam, a novel dopamine-1 receptor antagonist, is expected to enroll more than 220 patients across approximately 90 sites, making it the largest trial ever conducted in North America for this serious central nervous system disorder.
Emalex Biosciences was created by Paragon Biosciences in 2018 to develop novel treatments for central nervous system (CNS) disorders.
“Emalex was founded specifically to tackle serious neurological conditions like Tourette Syndrome, recognizing that drug development for neurologic conditions is exceptionally difficult and few companies are willing to invest in bringing new options to these patients,” said Jeff Aronin, Emalex founder and Paragon Biosciences CEO. “Our team has a strong track record of success developing neurology drugs and we are pleased to partner with our investors to advance ecopipam for patients.”
The funding comes following positive Phase 2b clinical trial results (D1AMOND Study) that showed the investigational new drug ecopipam reduced motor and phonic tics as compared to placebo. The most frequent adverse events related to ecopipam in the study were headache, fatigue, somnolence, insomnia and restlessness. Patients in the trial did not have observable evidence of adverse movement or metabolic side effects commonly reported with antipsychotic agents.
Tourette Syndrome is associated with both increased mortality and significant morbidity. In the majority of individuals, Tourette substantially impacts day-to-day physical and social function.
“Tic disorders can have severe social and psychological consequences for patients, and there currently aren’t many medications that effectively reduce tics without causing unhealthy side effects. Ecopipam has a novel mechanism that targets the D1 receptor, which is a new class of neurology drug,” said Donald Gilbert, MD, a movement disorders specialist at the Cincinnati Children’s Hospital. “It’s important to note that a large number of patients with Tourette Syndrome have co-morbidities like ADHD or OCD. During the Phase 2b study they were allowed to continue their medications for those conditions, and their Tourette symptoms measurably improved with ecopipam.”
Emalex’s first-in-class development candidate ecopipam, a novel investigational compound that is being studied as a potential treatment for certain central nervous system disorders, blocks the actions of the neurotransmitter dopamine at the D1 receptor. Dopamine is a neurotransmitter in the central nervous system, and its receptors have been classified into two “families” based on their genetic structure: “D1” (including subtypes D1 and D5) and “D2” (including subtypes D2, D3, and D4). D1 receptor super-sensitivity may be a mechanism for the repetitive and compulsive behaviors associated with Tourette’s. Currently approved therapies for the treatment of Tourette’s act at D2 receptors.
Ecopipam has been shown to be generally well tolerated in clinical trials conducted to date and has received Orphan Drug and Fast Track designation from the FDA for the treatment of patients with Tourette’s. Adverse events affecting primarily the central nervous system have been reported in clinical trials conducted to date, including headache, fatigue, somnolence, insomnia, restlessness, anxiety, depression and rarely, suicidal ideation.
About Emalex Biosciences
Emalex Biosciences was created by Paragon Biosciences to develop new treatments for central nervous system disorders. Emalex is in late-stage development of a new class of drug targeting the D1 receptor for patients with Tourette Syndrome and other conditions that have limited treatment options. Visit https://emalexbiosciences.com to learn more.
About Paragon Biosciences, LLC
Paragon Biosciences is a global life science leader that creates, builds and funds innovative biology-based companies in three key areas: cell and gene therapy, biology engineering and advanced biotechnology. Our portfolio companies use biology to accelerate scientific breakthroughs that solve some of society’s most challenging problems. Learn more at https://www.paragonbiosci.com.
About Bain Capital Life Sciences
Bain Capital Life Sciences (www.baincapitallifesciences.com) invests in pharmaceutical, biotechnology, medical device, diagnostic, and life science tool companies across the globe, with a focus on companies that both drive medical innovation across the value chain and enable that innovation to improve the lives of patients with unmet medical needs. The differentiated skillset of Bain Capital Life Sciences team enables it to deliver targeted capital and value-added strategic support to companies around critical phases of growth and inflections in value. Since 1984, Bain Capital has employed a strategic and analytical approach to identify attractive investment opportunities and partner with management teams to transform and improve their businesses. During this time, Bain Capital has developed global reach, deep expertise, and a proven track record in the life sciences industries across private equity, public equity, credit, venture capital, and real estate.