The FDA’s designation is designed to expedite the review of treatments.
It offers opportunities for more frequent discussions with the FDA regarding the clinical development plan of a drug and may enable eligibility for accelerated approval or priority review.
Halda Therapeutics president and CEO Christian Schade said: “We are pleased HLD-0915 has been granted fast track designation by FDA for patients with mCRPC.
“Fast track designation is an important step forward as we work to advance this programme through clinical development and, ultimately, to bring a novel, highly selective, oral-based treatment option to patients living with this challenging disease.”
At present, Halda is enrolling participants in its first-in-human Phase I/II study for assessing the tolerability and safety of HLD-0915 in treating mCRPC.
This open-label, multi-centre study is also assessing the pharmacokinetics, pharmacodynamics and anti-tumour activity of the orally administered therapy as a single agent.
The protocol includes an initial Phase I dose escalation for determining the maximum tolerated dose and/or recommended dose for expansion.
Following this, Phase II expansion cohorts will further assess HLD-0915’s safety and efficacy profile.
The bifunctional small molecule therapy HLD-0915 is designed to drive specific interactions between selected proteins for obtaining optimal activity and pharmacology, as demonstrated in the preclinical clinical trials of the company.
HLD-0915, when given orally, resulted in shrinkage of tumours and declines in prostate-specific antigen, in preclinical models for prostate cancer.