DNB Markets - Isofol Medical: Update on clinical development
Isofol Medical yesterday gave an update on several of its clinical programmes. The AGENT study has randomised 200+ patients and is rapidly approaching interim analysis in Q4 2020e. The company also reported the phase I/IIa study ISC-CC-005 had been concluded and a gene expression analysis method had been validated. We reiterate our SEK18–49 fair value.
AGENT study progressing to plan; interim analysis rapidly approaching. The ongoing phase III AGENT is progressing according to plan and has randomised 200+ of the planned 440 patients. The trial is rapidly approaching the next milestone of 330 treated patients, when the interim analysis will start. The interim analysis is expected to commence in Q4 2020 and it will take an independent Data Safety Monitoring Board (DSMB) c12 weeks to review safety and efficacy with three possible outcomes: 1) stop the study due to excessive toxicity; 2) consider stopping the trial due to overwhelming efficacy and submit a New Drug Application (NDA); or 3) increase the sample size to reach statistical significance on PFS. Given there have been no safety concerns, and as recent as December 2019 the DSMB recommended the continuation of the study, we find it unlikely it will be terminated based on excessive toxicity. We view the third outcome as the most likely. Once all 330 are recruited, they will be followed for 16 weeks and it will take the DSMB 12 weeks to review, so we are likely looking at a potential positive trigger around end-2020.
Phase I/IIa-study ISC-CC-005 has concluded. The original aim of the trial was to determine an effective and safe dose of arfolitixorin for the AGENT study. The study was expanded to determine the safety profile of arfolitixorin in combination with 5-FU, oxaliplatin and bevacizumab, which is now used in the ongoing phase III study. The study has fulfilled its purpose and final analysis has started with the data expected to be presented at ESMO 2020 (September 2020). We view this as a sound decision as the trial has achieved its objective and resources can be fully committed to the development of the AGENT study.
Method for gene expression analysis validated. The analysis included academic data from c450 patients treated with 5-FU and leucovorin containing regimens and indicates there is a difference in progression-free survival between patients that have a high expression of certain folate genes and patients with lower expression. The validation was requested by regulatory authorities to be used on clinical practice. With a validated method, Isofol Medical now has a biomarker that can be used when stratifying patients and exploring other cancer indications where 5-FU is standard of care.
We reiterate our fair value of SEK18–49. We have raised our R&D estimates slightly to reflect the ongoing clinical development; however, this does not affect our fair value.
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Best regards,
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Patrik Ling | DNB Markets | Equity Research | Senior Analyst Healthcare
DNB Bank ASA
Regeringsgatan 59 | Stockholm | Sweden
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David Martinsson | Markets | Equity Research | Healthcare
DNB Bank ASA, Filial Sverige
Regeringsgatan 59 | Stockholm | Sweden