Dundee spinout Amphista therapeutics reaches major milestone as first patient is dosed with their frontline degrader drug

Amphista Therapeutics, the targeted protein degradation (TPD) company which was ‘spun out’ from Professor Alessio Ciulli’s laboratory at the University of Dundee, has announced that the first patient has been dosed in a Phase 1 clinical trial of AMX-883, its first programme to enter the clinic. 

Initiated following authorisation from the U.S. Food and Drug Administration in June 2026, the BRAMLIE trial will investigate the safety, pharmacokinetics, and preliminary efficacy of AMX-883 monotherapy in participants with AML and high-risk myelodysplastic syndrome (MDS).

BRAMLIE is expected to enroll approximately 54 patients across multiple sites. After establishing the monotherapy profile, a multi-centre dose-escalation study would evaluate AMX-883 in combination with current standards of care in participants with relapsed/refractory AML as well as in earlier lines of therapy.

AML is an aggressive blood cancer causing around 130,000 deaths globally each year, with most patients receiving traditional cytotoxic chemotherapy. Although novel targeted agents can be effective, the use of these is restricted to specific mutations – and therefore target only a subset of AML patients – highlighting a need for broad-acting therapeutics.

AMX-883 degrades its target protein rather than just inhibiting as conventional drug do. Preclinically, it has demonstrated activity across diverse AML subtypes, independent of mutation status.

Amphista Therapeutics Ltd was founded in 2017 from research originating in the laboratory of Professor Alessio Ciulli, one of the pioneers of targeted protein degradation, within Dundee’s School of Life Sciences.

For a spin-out company like Amphista, reaching first-in-human clinical development is an important milestone in the long journey from fundamental research to potential new medicines, and an opportunity to recognise the scientists, entrepreneurs, investors and teams who have contributed at different stages of Amphista’s journey. 

Professor Ciulli, who founded and heads Dundee’s Centre for Targeted Protein Degradation (CeTPD), said, “This is a great step for Amphista, and hopefully ultimately for the many patients suffering with these terrible diseases, who are left with no other therapeutic options. Just earlier this year, TPD witnessed its very first drug molecule of this type ever approved by the FDA for medical use in patients with breast cancer. This is yet another milestone for the field.  

“It is also a reminder of what can grow from basic discovery science and why creating the right environment for today’s researchers, innovators and emerging companies matters for the innovations of tomorrow.

“We have a strong track record of doing this in Dundee and through our ongoing work, and the provision of tremendous infrastructure such as our CeTPD, and our Life Sciences Innovation Hub based in the city, we are looking to create more opportunities to translate high quality fundamental research into new medicines and treatments, with associated commercial impact.

“Life Sciences is a real area of strength for Dundee and Scotland that needs to continue to be supported and nurtured, so that we can not only create the optimum conditions to spin-out new activity, but also retain it in Scotland.”