The fall investor conference circuit is in full swing. The presentations typically are great for people who have no insight into the companies, but rarely do they offer up any new information. But Incyte (Nasdaq: INCY) bucked the trend Tuesday, when it used its presentation to announce positive clinical trial data for two of its compounds.
The company reported on two trials for its janus-associated kinase (JAK) inhibitor. The JAK protein has been implicated in a wide range of diseases and Incyte appears to be trying to hit them all. Its topical formulation of the drug -- mellifluously named INCB18424 -- showed a positive trend in healing psoriasis lesions in a 28-day phase 2b/2a trial. After taking care of some safety trials in the first half of next year, Incyte expects to start a three-month trial. The longer trial should help it show a distinct difference between the patients getting the drug and those in the control arm of the study.
Incyte also reported on an oral version of INCB18424 to treat myelofibrosis, a bone marrow disease. The company is waiting until the American Society of Hematology meeting in December to present the complete data, but the data for the two patients it did present was exceptional, with a remarkable shrinking of the spleen in four to eight weeks. Given that there are no drugs for treating myelofibrosis, look for Incyte to apply for orphan drug status and try to get an expedited review from the FDA. So-called orphan drugs treat rare diseases.
The second drug presented was its 11beta-HSD1 inhibitor, INCB13739, which treats Type 2 diabetes. Because of the shortness of the trial, the company is pretty happy with seeing a positive trend in the lowering of fasting glucose levels, with a statistically significant lowering of the most severely ill patients' glucose levels.
Incyte plans to start a longer three-month phase 2b trial in the first half of next year. If the trend continues in that trial, the phase 3 trial will need to be rather large, so look for Incyte to license the drug to a company with diabetes experience, such as Novo Nordisk (NYSE: NVO) or GlaxoSmithKline (NYSE: GSK).
The company has five other drugs in early-stage clinical trials, including its CCR2 antagonist (anti-inflammatory) program, which it has partnered with Pfizer (NYSE: PFE). With about $290 million to burn and expected losses for the year in the $90 million range, Incyte is a shining example of a developmental-stage drugmaker. It will live and die by its clinical trials, but so far things look very promising.
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