- Cynata Therapeutics (CYP) receives approval from the US Food and Drug Administration (FDA) to commence its Phase 2 clinical trial of CYP-001
- CYP-001 is the company’s lead product aimed at treating patients with acute graft versus host disease (aGvHD)
- The planned Phase 2 aGvHD trial will be the company’s first clinical trial conducted in the US, which is the largest healthcare market worldwide
- Enrolment for the trial is expected to begin later this year, with results of the primary evaluation anticipated in early 2024
- Cynata Therapeutics shares are up 11.1 per cent, trading at 40 cents as of 10:14 am AEST
Cynata Therapeutics (CYP) has had its investigational new drug (IND) application approved by the US Food and Drug Administration (FDA), allowing the Phase 2 clinical trial of CYP-001.
CYP-001 is Cynata’s lead product aimed at treating patients with acute graft versus host disease (aGvHD).
Chief Operating Officer Dr Kilian Kelly said the approval represents “a hugely important milestone in the development of CYP001 and our Cymerus platform.”
“Clearance of our IND application confirms that the FDA is satisfied with both the clinical and preclinical data as well as the manufacturing and quality control data on our product that we submitted in support of this application,” he said.
Dr Kelly also said the company previously completed several positive interactions with the FDA, as well as securing orphan drug designation for CYP-001 in 2018.
The planned Phase 2 aGvHD trial will be the company’s first clinical trial conducted in the US, which is the largest healthcare market worldwide.
The clinical trial will seek to recruit approximately 60 patients with high risk aGvHD,
at clinical centres in a number of countries, including the US and Australia.
The primary objective of the trial is to assess efficacy of CYP-001 in subjects with high risk aGvHD by overall response rate (ORR) at Day 28.
Participants will be randomised to receive either CYP-001 or placebo, in addition to corticosteroids.
The trial is expected to commence enrolment later this year, with results of the
primary evaluation expected in early 2024.
Cynata Therapeutics shares were up 11.1 per cent, trading at 40 cents as of 10:14 am AEST.