NEWS
March 28, 2024
AEOVIAN PHARMACEUTICALS DOSES FIRST PARTICIPANTS IN PHASE 1 CLINICAL TRIAL, STRENGTHENS LEADERSHIP TEAM AND RAISES ADDITIONAL $50 MILLION FINANCING
First Cohort of Participants Dosed in Phase 1 Clinical Trial with Lead Development Candidate AV078 Intended for the Treatment of Seizures Associated with Tuberous Sclerosis Complex (TSC)
Leadership Team Strengthened with the Appointment of William Greene, MD, CIO at Hevolution, and Justin Gover, Former CEO at GW Pharmaceuticals to the Board of Directors, and Micah Zajic Appointed as CFO
$50M Financing Led by Hevolution
ABOUT US
Aeovian Pharmaceuticals is a clinical-stage biopharmaceutical company developing targeted and highly selective small molecules to restore cellular metabolic quality control, thereby addressing the dysregulated growth and hyperactive signaling found in certain rare genetic and age-related diseases.
Our lead development candidate, AV078, is a first-in-class CNS penetrant selective mTORC1 inhibitor being developed for the treatment of tuberous sclerosis complex (TSC) refractory epilepsy and is currently being evaluated in a Phase 1 trial. TSC is a rare genetic disorder caused by the hyperactive signaling of mTORC1.
Beyond AV078, we have developed a proprietary library of small molecules, which are potent and selective inhibitors of either mTORC1 or CD38 and have the potential to precisely target the underlying biology of multiple rare and age-related diseases.
OUR PIPELINE
OUR SCIENCE
Mechanistic target of rapamycin (mTOR) is an evolutionarily conserved kinase that serves as the catalytic center of two distinct protein complexes, mTOR Complex 1 (mTORC1) and mTOR Complex 2 (mTORC2).
These complexes serve as fundamental regulators of incoming environmental and nutritional signals, and finely regulate anabolic and catabolic functions to maintain healthy cellular homeostasis.
In healthy individuals, mTORC1 and mTORC2 are in balance. However, in certain disease states mTORC1 becomes hyperactivated, leading to dysregulation of multiple physiologic processes including protein synthesis, cellular growth and signaling.
Our lead indication, tuberous sclerosis complex, is a rare genetic disorder resulting from mutations in the genes TSC1 or TSC2, leading to loss of function of the normal physiological role of the TSC protein complex in downregulating the activity of mTORC1. In TSC patients, overactivation of mTORC1 has severe clinical consequences that can often include medically intractable epilepsy which is extremely difficult to manage with currently available treatments.
Rapamycin and its previously developed analogs functionally result in nonselective inhibition of mTORC1 and mTORC2, and this nonselective profile has been associated with tolerability issues that limit their use in TSC and other disorders of selective mTORC1 overactivation. The nonselective mTORC1/mTORC2 inhibitor everolimus has demonstrated a partial degree of efficacy in TSC epilepsy, but its clinical use has been limited due to dose-limiting toxicities likely stemming from its undesirable off-target inhibition of mTORC2. These often result in dose reductions or interruptions which in turn limit achievable efficacy. The suboptimal safety and efficacy profile of nonselective mTORC1/mTORC2 inhibitors has resulted in a significant ongoing unmet medical need for a next-generation treatment able to achieve improved safety and efficacy by selectively targeting the mTORC1 overactivation associated with TSC. As such, we believe TSC is an exceptionally clear and compelling precision medicine target for AV078, our first-in-class CNS-penetrant selective inhibitor of mTORC1.
"We need a better response rate and less high-dose mediated side effects in the treatment of seizures. Current mTOR inhibitors, despite their positive efficacy in certain epilepsies, have a lot of issues, the most significant of which is safety..."
David N. Franz, Cincinnati Children's Hospital
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2930 Domingo Ave
Suite 145
Berkeley, CA 94705
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For general inquiries: info@aeovian.com
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For partnerships & business development: bd@aeovian.com