Atavistik Bio Partners with Cure HHT Clinical Trial Network to Advance Development of ATV-1601 for Hereditary Hemorrhagic Telangiectasia
- Partnership with Cure HHT strengthens patient engagement and supports streamlined clinical trial execution
- Harmony-HHT Phase 1/2 trial activates first clinical site at Massachusetts General Hospital, marking an important milestone for ATV-1601
CAMBRIDGE, Mass., July 30, 2026 (GLOBE NEWSWIRE) -- Atavistik Bio, a clinical-stage biotechnology company developing the next generation of oral selective allosteric therapeutics for the treatment of rare hematological diseases, today announced it has joined the Cure HHT Clinical Trial Network (CTN) to support the clinical development of ATV-1601, an investigational oral allosteric AKT1-selective inhibitor for the treatment of Hereditary Hemorrhagic Telangiectasia (HHT).
Joining the Cure HHT CTN coincides with activation of the first clinical site in Atavistik Bio’s Harmony-HHT Phase 1/2 study at Massachusetts General Hospital (MGH), marking an important milestone in the advancement of the clinical program.
Through participation in the Cure HHT CTN, Atavistik Bio will work closely with Cure HHT to leverage the organization's trial-qualified Centers of Excellence, established patient and clinician community, and extensive HHT-specific clinical and regulatory expertise to support execution of the Harmony-HHT study. The Cure HHT CTN is a first-of-its-kind partnership platform designed to accelerate development of new therapies for HHT.
"As our Harmony-HHT Phase 1/2 trial advances into the clinic, our partnership with Cure HHT strengthens our ability to engage and contribute to the HHT community in addition to efficiently executing the study," said Susan Pandya, M.D., Chief Medical Officer of Atavistik Bio. "Beyond activating our first clinical site at the world-renowned HHT Center of Excellence, Massachusetts General Hospital, this collaboration connects us with a global network of HHT experts, clinical investigators, and patient advocates who share our commitment to accelerating the development of novel treatment options."
Through the collaboration, Atavistik Bio and Cure HHT will work together on patient education, community outreach, clinical trial awareness initiatives, and engagement activities designed to help connect eligible individuals with the Harmony-HHT study.
"We are thrilled to welcome Atavistik Bio to the Cure HHT Clinical Trial Network," said Marianne Clancy, CEO, Cure HHT. "ATV-1601 represents an exciting investigational approach for HHT, and we look forward to partnering with the Atavistik Bio team to help connect the HHT community with the Harmony-HHT study and support the development of potential new therapies for people living with this disease."
HHT is the second most prevalent inherited bleeding disorder, affecting more than 80,000 people in the US and 1.6 million people globally, with no approved therapies currently available. HHT is caused by loss-of-function mutations in ENG, ALK1 or SMAD4 genes which encode proteins that regulate the growth and branching of endothelial cells into blood vessels. Impaired function of these proteins results in hyperactivation of the AKT1 pathway resulting in malformed blood vessels called arteriovenous malformations (AVMs), which can rupture or cause abnormal blood flow, leading to chronic bleeding, anemia, organ damage, and for some, life-threatening complications. There are currently no approved therapies for HHT.
ATV-1601 is an investigational oral allosteric inhibitor that selectively targets AKT1, a key driver of the vasculopathy underlying HHT. By selectively inhibiting AKT1, ATV-1601 has the potential to provide a disease-modifying approach for HHT, with the potential to address all HHT-driver mutations (ENG, ALK1, and SMAD4) with a well-tolerated profile. In preclinical HHT models with ENG, ALK1, and SMAD4 mutations, ATV-1601 significantly reduced AVM formation, supporting its potential as a novel therapy applicable for all people living with HHT. ATV-1601 has received FDA Fast Track designation for the treatment of HHT.
The Harmony-HHT Phase 1/2 clinical trial (NCT07601425) is a proof-of-concept study designed to evaluate the safety and efficacy of ATV-1601 for individuals with moderate to severe HHT. Part 1 is a randomized, double-blind, multicenter, placebo-controlled study evaluating three oral dosing regimens of ATV-1601 over a 16-week treatment period. Eligible participants who complete Part 1 may enroll in an open-label extension (Part 2) to receive ATV-1601.
About Atavistik Bio
Atavistik Bio is a clinical stage biotechnology company advancing a pipeline of hematology therapeutics developed through a novel allosteric discovery approach. Atavistik Bio is advancing multiple programs with best-in-class potential, including the lead asset, ATV-1601, an investigational oral allosteric AKT1-selective inhibitor for the treatment of Hereditary Hemorrhagic Telangiectasia (HHT) and advancing a JAK2V617F mutant-selective inhibitor program for myeloproliferative neoplasms.
Atavistik Bio is led by an experienced team of drug hunters with a proven track record of developing marketed small molecule therapies and supported by top-tier investors, including The Column Group, Nextech Invest, Lux Capital, Regeneron Ventures, and RA Capital Management. To learn more, visit us at atavistikbio.com and follow us on LinkedIn.
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