For those new to the 4D Pharma story30 May 2020 13:22
The Company is involved in the field of Live Biotherapeutics and has made great progess over the past 5 years, with its own manufacturing facility, a really strong IP position and has just finished a few clinical trials.
The concept is to use the bodies own bacteria to fight disease. In effect to use them as a drug without the safety issues. 4d has just finished the safety part of a 12 patient phase 1/11 oncology trial.The patients involved are extemely sick, having had multiple lines of therapy, chemo, radio, checkpoint therapy and unfortunately nothing had worked for them. "What we are seeing is remarkable." Combining with the Merck Keytruda drug, we are able to re-engage the immune system to get responses in a number of patients, "with really impressive duration responses." The trial is about to be extended to 100 or so patients, opening another 4 sites in the US. (I don't believe the US connection and importance to 4D's work should be understated)
They have also just completed a Phase 11 trial involving 370 plus patients for IBS, with top line data expected towards the end of summer.
A phase 11 trial for Crohns is about to start in the UK, aimed at a young age group who don't really have alternative effective therapies.
In a phase 11 Asthma trial conducted in the US for 90m patients, they were able to dampen down lung inflamation in a number of ways using a very simple and safe to take drug.
Given the data acquired on SARS CoV-2, the Company believes that the Asthma trial therapy, using MRx-4 can be effective in the treatment of CV19 because of its anti inflammatory properties. It is believed its use will stop patients progressing to oxygen use or ventilation by dampening the inflammatory response.
4D were able to fast track the CV19n trial because of the safety profile of MRx-4 in the Asthma trial and the MHRA were really responsive, with concept to approval only taking 4 weeks. They are now ramping up the centres and are getting ready to dose patients. "We should be very close." (as Duncan Peyton bit his lower lip) The study will involve 90 patients across 4 sites, maybe increasing to 8.
Ideally the data will be out before the end of the year, early 2021 but as previously pointed out, the patients will be on an initial treatment regime lasting 14 days.
4D are working on both propriety and partnership progammes. The Merck collaboration involves Keyruda but they are also working with Merck to see how the Live Biotherapeutics/ Microbiome platform can be used to develop the next generation of vaccines.
In group discussions (pre lockdown at the boozer) most excitement centres around Asthma and Oncology "but with the data we are seeing from the oncology programme, the majority of people have moved across the the oncology camp" (an effective asthma therapy isn't a bad number 2) "and the data really is remarkable. Hopefully we will be able to talk about it in alot more detail soon."