Allakos Inc (NASDAQ:ALLK) recently announced that the findings from its phase 2 study evaluating lirentelimab (AK002) were published in the latest edition of the New England Journal of Medicine (NEJM).
Allakos has been developing lirentelimab as a potential therapy for mast cell and eosinophil-related illnesses. The published data was observed from the placebo-controlled, double-blind, and randomized phase 2 study evaluating lirentelimab as a potential treatment for eosinophilic duodenitis (ENIGMA) and eosinophilic gastritis.
According to the data published n NEJM, AK002 demonstrated statistically significant results in all the dose categories of the phase 2 study especially compared to the placebo arm. The results were also consistent in all the primary and secondary endpoints. This includes the patient-reported disease and the gastrointestinal tissue eosinophil data.
Eosinophilic duodenitis, eosinophilic gastritis, and eosinophilic esophagitis have one main thing in common and it is that they are all severe inflammatory illnesses in which patients have high eosinophils levels in the esophagus, stomach, and duodenum. Some of the symptoms that patients with these diseases experience include weight loss, dysphagia, vomiting, lack of appetite, nausea, bloating, diarrhea, bloating, and severe abdominal pain.
Lirentelimab targets untapped patient demography, allowing it to make an impact on patients
It is estimated that roughly 150,000 people in the U.S and roughly 50,000 people suffer from eosinophilic duodenitis and eosinophilic gastritis. This is a sizable number of people that suffer from these diseases but the problem is that there are no approved therapies that target them. Systemic steroids are the most commonly recommended types of treatment. However, the steroids cause various side effects especially over the long-term, making them less efficient as a treatment option.
Allakos wants to focus on the treatment of eosinophilic duodenitis and eosinophilic gastritis patients, thus pushing forward with Lirentelimab’s development. Lirentelimab has already received new drug designation status from the FDA as a treatment for eosinophilic esophagitis, eosinophilic gastroenteritis, and eosinophilic gastritis. Allakos is confident that the recently published phase 2 study data will be enough to facilitate further approvals that will allow the company to advance Lirentelimab with the eventual goal of bringing it to the market.