Halda Therapeutics announced that the FDA granted Fast Track designation to HLD-0915, the company’s lead development candidate, for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC).
“We are pleased HLD-0915 has been granted Fast Track designation by FDA for patients with mCRPC,” said Christian Schade, President and CEO of Halda Therapeutics. “Fast Track designation is an important step forward as we work to advance this program through clinical development and, ultimately, to bring a novel, highly selective, oral-based treatment option to patients living with this challenging disease.”
FDA’s Fast Track designation is designed to ensure that important new treatments can reach patients as quickly as possible. A drug receiving Fast Track designation is eligible for more frequent meetings and written interactions with FDA to discuss the drug candidate’s clinical development plan, including possible eligibility for accelerated approval and priority review.
Halda is currently enrolling patients in the first-in-human, Phase 1/2 clinical trial (NCT06800313) to evaluate the safety and tolerability of HLD-0915 in the treatment of metastatic castration-resistant prostate cancer (mCRPC). The Phase 1/2 open label, multi-center clinical trial is designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and anti-tumor activity of orally administered, single-agent HLD-0915 in patients with mCRPC. The study includes an initial Phase 1 dose escalation to determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion of HLD-0915 as a monotherapy and Phase 2 expansion cohorts to further evaluate the efficacy and safety of HLD-0915.
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