Protagonist Therapeutics Inc (NASDAQ: PTGX) announced that it has received positive results from its Phase II study of PN-943 in moderate or severe ulcerative colitis patients. According to Protagonist’s CEO and President, Dinesh V. Patel, the results encourage the company to conduct a Phase III study. Moreover, Protagonist is happy to cooperate with regulators to ensure the studies run smoothly.
PN-943 was effective against ulcerative colitis
Patel adds that their oral drug has shown similar efficacy to the injectable drug used to treat the same disease. He states that this could make PN-943 the first-line drug since oral administration is safe and effective.
Protagonist Therapeutics’ Head of Gastroenterology and Executive VP, Dr Scott Plevy, states that the drug has shown efficacy for treating ulcerative companies. He explains that the study evaluates a 450mg and 150mg dose of the therapy. The researchers discovered that the lower dose was still effective on volunteers.
In addition, the data from this study will help the company determine the efficacy and correct dosing of the drug for the Phase III trial.
One of Protagonist’s consultants and lead study author for the trial, Dr Bruce Sands, states that the oral drug, which could be taken twice a day has a similar effect as injectable-alpha-4-beta integrin. The latter was long approved to treat ulcerative colitis. Moreover, the drugs have the same mode of action.
How researchers conducted the study
The study, which the researchers named IDEAL, was a multicentre, placebo-controlled, double-blind, randomised trial that evaluated the efficacy and safety of PN-943. Researchers used 15 ulcerative colitis patients and gave them a placebo or 150mg or 450mg of oral PN-943. After administering the drug for 12 weeks, the researchers evaluated them.
The company plans to hold a conference call which Sand will attend. Protagonist Therapeutics will then discuss its findings for investors, the general public, and the media.
Protagonist Therapeutics is a company that uses its technology platform to create therapies derived from peptides. The company has used its technology to create several drugs, including rusfertide, still under investigation.
The company is also in several trials, including the REVIVE Phase II study. This study evaluates the efficacy and safety of hepcidin mimetic in patients with polycythaemia vera. The company is also conducting a PACIFIC Phase II study for polycythaemia vera patients with high haematocrit.
