Asahi Kasei Pharma and Alchemedicine have pushed a promising new drug candidate into human trials, marking a critical milestone in their bid to tackle diseases that defy standard treatment.
The companies announced Wednesday that AK1960, a novel Endothelin A (ETA) receptor antagonist, has successfully completed preclinical development and entered a Phase I clinical study. The small molecule therapy is designed to target refractory diseases — conditions resistant to existing therapies — including hard-to-control chronic kidney disease.
AK1960 is built on Alchemedicine’s HiSAP medicinal chemistry platform and features a new core molecular structure. In preclinical studies, it demonstrated high selectivity and potent inhibition of the ETA receptor, along with strong efficacy in animal models for kidney disease.
The move into Phase I signals the first time the therapy will be tested in humans and represents a significant step forward in Asahi Kasei Pharma’s strategy to expand its global healthcare footprint.
“The advancement of AK1960 into a Phase I study reflects an important milestone for Asahi Kasei Pharma and demonstrates our close collaboration with Alchemedicine to address unmet medical needs,” said Yasuo Nakamura, Director and Senior Executive Officer at Asahi Kasei Pharma.
“Since 2022, we have worked to overcome technical challenges, validate the therapeutic concept, and prepare for clinical evaluation. By leveraging the expertise of Calliditas and Veloxis in therapeutic development, we will continue advancing AK1960. Together, we are building a system that demonstrates scientific excellence while creating meaningful impact for real-world health settings.”
Under an exclusive licensing agreement signed in 2022, Asahi Kasei Pharma secured worldwide development and commercialization rights to Alchemedicine’s ETA receptor antagonist program. While preclinical and Phase I studies are being conducted in Japan, the therapy is intended for the global market.
To accelerate development, the broader Asahi Kasei Group will draw on the expertise of Calliditas Therapeutics AB and Veloxis Pharmaceuticals, Inc. — two subsidiaries with established experience in therapeutic commercialization and specialty care.
