Published articles in peer review journals cited that pharmacologic inhibition of RORγt regulates Th17 signature gene expression and suppresses cutaneous inflammation in vivo. Here we are, a clinical stage small company called Vitae Pharmaceuticals (VTAE) has just announced positive results from its Phase 2a proof-of-concept clinical trial of its RORyt inhibitor drug VTP-43742 in psoriatic patients.
VTP-43742 is wholly owned by Vitae. It is an orally active RORyt inhibitor said to potentially transform the treatment of multiple autoimmune diseases, including psoriasis. The mode of action is the inhibition of IL-17 secretion from Th17 cells and blocking the IL-23 action.
A randomized, double-blind, placebo-controlled trial assessed the safety, efficacy, tolerability, pharmacokinetics and pharmacodynamics of multiple oral doses of VTP-43742in patients with moderate to severe psoriasis over a four-week period. In this trial, the drug demonstrated a clear signal of efficacy.
Patients on the 350 mg dose achieved a 24% reduction in the Psoriasis Area Severity Index (PASI)score relative to placebo.
Patients in the 700 mg dose achieved 30% placebo adjusted PASI score reduction.
For both doses, clinically relevant and statistically significant reductions relative to baseline values were observed.
Between weeks zero and two, there was a modest onset of PASI reduction, and for the last weeks of the study, particularly between weeks three and four, there was an acceleration of the rate of reduction in PASI score in both the 350 mg and 700 mg dose groups. These results suggest the potential for more reductions in PASI scores with longrer treatment durations.
While full efficacy is not generally seen before 12 weeks of continued treatment, the PASI score reductions with VTP-43742 after four weeks and the acceleration of the rate of pASI reduction between week three and four are consistent with the potential of achieving greater oral efficacy in psoriasis treatment.
VTP-43742 was generally well tolerated at all given doses with no serious adverse effects. No drug-related electrocardiogram abnormalities were observed. In the 700 mg group, reversible transaminase elevations were observe in four patients. Pharmacokinetics were consistent with once-a-day dosing.
The firm plans to advance VTP-43742 into a large scale 16-week trial in the second half of 2016.
The above results might validate RORyt as a target for inhibition by novel drugs aimed at treating psoriasis and autoimmune diseases. Vitae Pharmaceuticals’ drug VTP-43742 advantage is the fact that is an oral safe drug. In addition to psoriasis, whose trials have demonstrated proof of concept, Vitae Pharmaceutical drug could also become a treatment for many other inflammatory disease conditions considered autoimmune disease comprising psoriatic arthritis, rheumatoid arthritis, inflammatory bowel disease and other autoimmune diseases.
Convincing also were the biomarker assays measuring plasma IL-17A and IL-17F. The 350mg and 700 mg doses of VTP-43742 were shown to decrease both plasma cytokines by 75%, which is considered statistically significant and consistent with the change in PASI score from baseline.
We like the results and believe the drug will be a great competitor in the field of autoimmune inflammatory diseases.
The stock is currently trading at $7.69 UP over $3. The firm’s market cap is only 168.18, which we believe does not even consider the value of Vitae Pharmaceuticals drug VTP-43742.
The news is great for Vitae Pharmaceuticals.