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HAV-088 is a novel combination drug consisting of testosterone and anastrozole formulated as a subcutaneous implant. It is designed to provide three months of continuous medication for the treatment of hormone receptor-positive (HR+) breast conditions, including ductal carcinoma in situ (DCIS). The mechanism involves dual action: - Testosterone acts as an androgen receptor agonist, stimulating the androgen receptor pathway in breast tissue. This reduces estrogen-driven gene transcription and lowers estrogen receptor expression, thereby limiting tumor responsiveness to estrogen. - Anastrozole serves as a low-dose aromatase inhibitor, further reducing local estrogen production. The approach aims to offer benefits for patients with disease resistant to standard endocrine therapies by leveraging natural hormonal mechanisms with potentially fewer side effects. The product is being developed by Havah Therapeutics and Clarus Therapeutics and is currently under investigation in Phase 2 clinical studies for DCIS.
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