4D pharma PLC (LON:DDDD, NASDAQ:LBPS) said it has provided a more detailed analysis of its Live Biotherapeutic, Blautix, which is both significant and supportive of its continued development as an irritable bowel syndrome treatment.
The data, presented as a poster at the medical and scientific conference Digestive Disease Week, builds on the top-line results released last October.
The poster revealed “strong and statistically significant activity” on the key symptom of bowel habit, which 4D describes as a “potential approvable primary endpoint per regulatory guidelines”.
In an update, the company said there had been an “unusually high” response to the placebo treatment, which should have had no medically relevant impact on patients receiving it.
That said, Blautix was still shown to be “competitive” with approved IBS therapeutics. It is also the first therapeutic globally to have demonstrated efficacy in both IBS-C and IBS-D.
4D’s chief scientific officer, Dr Alex Stevenson, said the group had discussed the results with internationally renowned key opinion leaders and patient groups, which had further shored up confidence in the drug.
“We are encouraged by the positive outcomes of this additional analysis, and we strongly believe that this signal finding study supports the continued development of Blautix as a novel treatment for IBS," he added.
"The phase II results, in conjunction with regulatory guidance and KOL [key opinion leaders] discussions, provide a clear and viable path forward for 4D pharma to continue to develop Blautix to address a significant unmet need.”
The company is a specialist in the emerging area of the human microbiome (the bacteria that reside mainly in the gut) and has developed Live Biotherapeutics — products that contain live organisms such as human commensal bacteria.
The approach focuses on single strains to assess specific mechanisms of action targeting a defined disease pathway.
Toxicity has always been a major impediment to the success of new drugs.
In developing its Live Biotherapeutics, 4D has isolated bacteria from healthy human donors which are expected to have “highly attractive safety profiles”.