IBT's ongoing clinical phase III study with IBP-9414 has, as of the date of this year-end report, conducted patient recruitment for more than seven months.
We have, as previously communicated, the approval to conduct the study in
IBT expected the recruitment rate in the phase III study to approximate the rate noted during our concluded phase II study, and as previously communicated in the most recent financial report, we were not satisfied with the rate of recruitment. There have been a number of practical reasons, including misunderstandings regarding interpretation of an exclusion criteria, which precluded doctors from including patients in the study. This was addressed during the autumn.
We have focused our work on improving the recruitment rate in the study and IBT has visited nearly all open centers. We are now able to conclude that we can achieve similar recruitment rate as we achieved during the phase II study at centers which have initiated recruitment.
As of the date of this report 51 of a total of 100 planned centers have been contracted and we are working intensively to initiate more. Since the previous interim report we have further strengthened our clinical department at IBT in order to ensure that the 'best practice' is spread from the top recruiting centers to others.
During
The study is double blinded which means that we are not able to make observations regarding efficacy in our pharmaceutical candidate yet. However, we can observe important factors relevant for conducting the study. Firstly, we note that the relevant infants are recruited to the study which means that the infants meet the specific inclusion criteria. Secondly, we note that systems managing side effects, patient allocation and independent assessment of X-rays of NEC are conducted as planned. This means that the study is operationally progressing as expected.
Our ongoing study is randomized, double blinded and placebo controlled to assess safety and efficacy of IBP-9414 for prevention of of necrotizing enterocolitis ('NEC'), and also includes other important clinical effect parameters in feeding premature infants comprising so called feeding tolerance, thus comprising multiple endpoints. Hopefully the results from the study will show that our product will both reduce the risk that infants develop NEC, and additionally, that infants will be able to absorb nutrition better.
I also wish to state that IBT's liquidity is adequate to conduct the ongoing clinical phase III study in spite of the fact that the initial recruitment rate of the study did not meet our expectation. IBT's qualified team is working in a dedicated and focused manner with all vital details which are so important in order to reach our recruitment goals.
SIGNIFICANT EVENTS DURING THE FOURTH QUARTER (OCT-DEC) 2019
SIGNIFICANT EVENTS DURING THE REPORTING PERIOD (JAN-DEC) 2019
IBT signed its first distribution agreement on
On
IBT's IND-application (Investigational New Drug) was approved in the
IBT announced on
SIGNIFICANT EVENTS AFTER THE REPORTING PERIOD
IBT's clinical study application was approved in
No other significant events have occurred after the reporting period
ABOUT
IBT is currently developing the drug candidate IBP-9414, for the prevention of necrotizing enterocolitis ('NEC') and improvement of so called feeding tolerance in premature infants. IBP-9414 contains the active compound Lactobacillus reuteri, which is a human bacterial strain naturally present in breast milk. The product portfolio also includes another project, IBP-1016, for the treatment of gastroschisis, a severe and rare disease affecting infants. By developing these drugs, IBT has the potential to fulfill unmet needs for diseases where there are currently no prevention or treatment therapies available.
Contact:
Tel: +46 70 670 1226
This information is information that
(C) 2020 Electronic News Publishing, source