Lytix Biopharma has decided not to proceed with the planned clinical LTX-109 programme in mildly infected diabetic foot ulcers. The decision is based on recent information indicating that the study will take considerably longer time and incur significantly higher costs than estimated. The company will evaluate alternative routes for LTX-109.
LTX-109 has highly attractive and unique characteristics as an antimicrobial agent. Since Lytix Biopharma´s strategic focus is cancer immunotherapy, the aim for LTX-109 has been to find a partner for further development and commercialisation. The planned development programme in mildly infected diabetic foot ulcers (DFI) was designed to facilitate finding such a partner.
The main challenge with the planned mild diabetic foot infection study is related to the placebo-controlled design. The design is mandated by regulatory agencies, but not part of clinical expert standard of care treatment guidelines making it difficult to get approval from ethics committees, and also encountering reluctance from both physicians and patients to accept placebo as a treatment option. These factors are expected to have major implications for patient enrolment rates, requiring more centres to participate in order to conclude the study in a reasonable time, all contributing to increased trial costs. Recent information confirms very slow patient accrual in similar DFI trials to the one which Lytix Biopharma had planned.
Andrew Saunders, CMO of Lytix Biopharma, commented:
“LTX-109 has highly attractive and unique characteristics as an antimicrobial agent, but our assessment is that the planned study will not contribute to the value of LTX-109 in a timely and meaningful way. We will therefore seek alternative routes for the compound.”
Unni Hjelmaas, CEO of Lytix Biopharma, commented:”It has been a very difficult decision not to initiate the LTX-109 diabetic foot trial, but we have to apply the implications and consequences of recent information in order not to jeopardize our strategic focus on the oncolytic peptide immunotherapy LTX-315.”
Read article (only in Norwegian) in Nord24 based on this press release