Clinical Trial of Experimental Ulcerative Colitis Drug Humming Along

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Investors generally expect clinical trials to take a long time. That’s not always the case. Take Innovation Pharmaceuticals (OTCQB:IPIX), for example. Looking to build upon success during 2019 in its experimental drug program for inflammatory bowel disease, the company is starting 2020 off with an important study that looks like it will take only about a month.

Innovation previously completed a Phase 2 proof-of-concept clinical trial of Brilacidin, a novel drug known as a defensin mimetic, as a retention enema for ulcerative proctitis/ulcerative proctosigmoiditis. In the small study, the majority of patients demonstrated clinical remission of disease following Brilacidin therapy.

Subsequently, IPIX licensed the rights to that indication and delivery method to Italy’s Alfasigma S.p.A. for cash, future milestone payments and royalties should the drug be commercialized.

Management handed-off the UP/UPS indication to pursue larger opportunities in IBD, more specifically, ulcerative colitis. 

UC, a chronic disease of the large intestine (colon) and/or rectum, affects about one million people in the U.S. each year. Allied Market Research estimates the UC market is on the rise from $4.79 million in 2016 to $7.56 billion by 2023. An array of drugs are used to treat UC, including anti-inflammatory aminosalicylates like Colazal and Dipentum and antibiotics like ciprofloxacin when infections develop. 

Optimism surrounds a drug like Brilacidin for UC because it has been shown to have both anti-inflammatory and antibiotic properties.

One of the hurdles in treating UC is targeted delivery to the colon. To address this, Innovation partnered with BDD Pharma to use BDD’s delayed release tablet technology, called Oralogik™, for colonic delivery of the Brilacidin payload.

In order to test the safety, tolerability and assess the targeted delivery of the delayed-release Brilacidin tablets, IPIX is conducting a Phase 1 study in healthy volunteers. Dosing of first cohort (50mg Brilacidin) in the nine-patient study started on January 16, with dose escalation approved and the second cohort (100mg Brilacidin) underway just five days later, according to the company.

The company anticipates approval to raise the dose to 200mg per protocol and commence dosing the final cohort by the end of January. Top-line data on safety will follow shortly after. 

Researchers will use gamma scintigraphy to evaluate the transit of Brilacidin to the colon. Safety and tolerability are, of course, top priority, but targeted delivery to the intended site is not far behind in importance. 

No assumptions are ever made regarding safety, but the drug has already successfully completed a Phase 2b trial in IV form for severe skin infections (ABSSSI), a Phase 2 trial as an oral rinse for Oral Mucositis in Head & Neck Cancer patients and the Phase 2 PoC trial as a retention enema. To that point, there likely is a fair degree of confidence in the safety profile.

Looking to post a third straight day of gains, shares of IPIX are ahead 4.9% in Tuesday afternoon trading.