Chinese biotech company Asieris Pharmaceuticals has completed enrolment for its Phase Ib trial in the US to evaluate the safety, tolerability, and PK characteristics of APL-1202.
APL-1202 is the first oral and reversible methionine aminopeptidase II type (MetAP2) inhibitor and is currently being developed to treat non-muscle invasive bladder cancer (NMIBC), one of the most common malignant tumours.
The drug has novel mechanisms of action of inhibiting tumour cell growth as well as angiogenesis.
The Phase Ib clinical trial will evaluate APL-1202 in combination with intravesical BCG in NMIBC patients who have received at least one induction course of intravesical BCG.
Patient follow-up is expected to be completed in September this year.
Asieris plans to launch a Phase II global clinical trial to evaluate the efficacy and safety of a combination of the drug with BCG in patients with NMIBC.
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Asieris co-founder, chairman and CEO Kevin Pan said: “The completion of enrolment for our APL-1202 Phase Ib clinical trial in the US represents a remarkable milestone for APL-1202’s global clinical development.
“Intravesical BCG is the first-line therapy for NMIBC globally, and through the clinical trials of APL-1202 in combination with intravesical BCG, we hope to provide a better treatment for NMIBC patients in the world.”
The common treatment of NMIBC at present is Trans-Urethral Resection of Bladder Tumour (TURBT).
Asieris develops and commercialises new drugs for the treatment of genitourinary tumours and related diseases.