ALLK - Allakos Inc. down 80% after announcing topline phase III results from its Enigma II clinical study
Allakos Inc ( NASDAQ: ALLK ) announced its results from Enigma II, Phase III placebo-controlled, double-blind clinical research of lirentelimab on people battling EG (eosinophilic gastritis) and went up by around 80%.
The company also concluded its Kryptos study of lirentelimab on people with biopsy-confirmed EOE (eosinophilic esophagitis). Both the studies met all their co-primary endpoints.
How does top management feel?
Allakos’ Chief Executive Officer, Robert Alexander, Ph.D., said:
The company is grateful to the patients with eosinophilic gastrointestinal diseases (EGIDs) and to the investigators who participated in the ENIGMA and KRYPTOS trials.
However, Dr. Alexander claimed that they are deeply disappointed that both studies didn’t reach their symptomatic endpoints. Allakos’ Chief Medical Officer, Dr. Craig Patterson, added:
Although the EGID results are surprising and disappointing, we will continue to analyze the data to understand the results and to determine the path forward for lirentelimab in EGIDs.
Enigma’s phase III topline results
The core primary endpoints of both studies were
- The proportion of people achieving histologic results, and
- Symptomatic improvement in the 6 symptom TSS (total symptom score)
Patients who respond to the treatment well achieve peak eosinophil counts of an eosinophil count of fewer than 4 cells per HPF. The endpoint was assessed after the end of 24 weeks.
The trial’s safety results were also generally very consistent with the previously recorded lirentelimab clinical studies. The researchers didn’t observe any new safety signals. Moderate to mild infusion-based reactions happened in 34% of the people that got the lirentelimab treatments.
The placebo-controlled randomized Phase III trials of lirentelimab were conducted on around 180 people with EoD and/or EG. The patients needed to be severely or moderately symptomatic based for them to be viable for these studies.
Researchers measured disease symptoms daily during those 24 weeks that it took to conduct the whole study. Both studies only one of the co-primary endpoints researchers were looking for.
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