TSC Alliance Endowment Fund Invests in Aeovian Pharmaceuticals to Advance Development of an mTORC1 Selective Inhibitor for Tuberous Sclerosis Complex

SILVER SPRING, Md., Dec. 16, 2025 /PRNewswire/ -- The TSC Alliance Endowment Fund, a supporting organization of the TSC Alliance, has invested in Aeovian Pharmaceuticals as part of their Series B financing in support of their Phase 2 trial of AV078, a first-in-class CNS-penetrant selective mTORC1 inhibitor in tuberous sclerosis complex (TSC).

"This equity stake is in line with the TSC Alliance Endowment Fund investment policy, which allows for investments in venture capital and private equity that are directly related to advancing the TSC Alliance mission of catalyzing new treatments and driving research toward a cure," shared Rita DiDomenico, TSC Alliance Endowment Fund Chair. "Any earnings of this investment will go right back into fulfilling the mission of the organization."

In 2018, the TSC Alliance partnered with Aeovian Pharmaceuticals by co-funding research through the TSC Preclinical Consortium. This marked a significant step towards the development of innovative mTORC1-specific inhibitors for TSC, particularly in addressing TSC-associated epilepsy.  mTORC1 is a protein complex involved in cell growth and proliferation, known to play a pivotal role in TSC pathology. The TSC Preclinical Consortium provides a screening platform to identify lead clinical drug candidates through a systematic testing process in robust and reproducible models of TSC. Since 2016, the Preclinical Consortium has worked with 27 industry partners screening 97 compounds.

"AV078 represents the first drug candidate developed using the TSC Preclinical Consortium as the preclinical efficacy engine throughout the lead development processto identify a novel clinical candidate," said Steven L. Roberds, PhD, Chief Scientific Officer at the TSC Alliance. "We are thrilled our early investment to create the TSC Preclinical Consortium and ongoing partnership has helped enable Aeovian's groundbreaking work with AV078."

Following positive results in the first mouse study in 2018, Aeovian developed improved clinical candidates in partnership with the Preclinical Consortium over the next three years. From 2024 to 2025, AV078 completed Phase 1 testing in healthy volunteers.

"Our collaboration with the TSC Preclinical Consortium was instrumental in identifying and advancing AV078," said Allison J. Hulme, Ph.D. President & CEO, Aeovian Pharmaceuticals. "The Consortium's rigorous and disease-relevant models allowed us to rapidly evaluate selectivity, CNS penetration, and efficacy, giving us the confidence to move AV078 into clinical development. This partnership was critical in accelerating our path to Phase 2 trials."

Aeovian Pharmaceuticals will be moving into Phase 2 clinical trials of AV078. Information on the trial can be found at www.aeovian.com.

About Aeovian Pharmaceuticals

Aeovian Pharmaceuticals is a clinical-stage biopharmaceutical company developing targeted and highly selective small molecules that restore cellular metabolic quality control by inhibiting mTORC1 or CD38. The company's lead candidate, AV078, is a first-in-class CNS-penetrant selective mTORC1 inhibitor currently in Phase 2 development for refractory epilepsy associated with tuberous sclerosis complex (TSC), a rare genetic disorder driven by hyperactive mTORC1 signaling. Aeovian has also developed a proprietary library of potent, highly selective inhibitors with the potential to address multiple rare and age-related diseases. For more information, visit www.aeovian.com.

About the TSC Alliance Endowment Fund

The TSC Alliance Endowment Fund is a separate fiduciary organization specifically chartered to receive gifts that will be invested to generate an income stream that will help fulfill the mission of the TSC Alliance. The Endowment Fund ensures a permanent source of funding to better serve families touched by TSC through research, family services, and education. For more information, visit tscalliance.org/endowment.

About the TSC Alliance

The TSC Alliance is an internationally recognized nonprofit that improves quality of life for everyone affected by tuberous sclerosis complex by catalyzing new treatments, driving research toward a cure and expanding access to lifelong support. For more information, visit tscalliance.org.

Contact
Dan Klein
Senior Director, Communications
TSC Alliance
(301) 562-9890
[email protected]

SOURCE TSC Alliance