Generic drug company Glenmark recently spun out Ichnos Sciences, which completed enrollment for two Phase IIb clinical trials testing target investigational products for atopic dermatitis and a non-opioid drug osteoarthritic pain.
What are the investigational drugs?
These two clinical candidates, recently achieving a major milestone of completion of patient enrollment target include ISB 830, an OX40 antagonist, and ISC 27864, a non-opioid, potent selective and orally bioavailable inhibitor of microsomal prostaglandin E synthase-1 (mPGES-1) currently in development for osteoarthritic pain. We summarize the clinical trials and the investigational candidates below.
Known as AD, it is the most common type of eczema. More than 18 million American adults struggle with the condition, which often appears as a red, itchy rash normally on the cheeks, arms and legs. Although there are treatments, there are no cures.
Ichnos Sciences’ ISB 830 is an OX40 antagonist monoclonal antibody currently in development for the treatment of atopic dermatitis. In the randomized, double-blind, placebo-controlled study of ISB 830, three different doses/regimens of the monoclonal antibody are being evaluated in adult patients with moderate to severe atopic dermatitis.
A total of 312 patients were randomized at sites in the U.S., Canada and Europe. The primary endpoint being evaluated is the proportion of subjects with both investigator’s Global Assessment (IGA) of 0 to 1 (on a 5 scale) and an IGA reduction from baseline of ≥2 points the end of 16 weeks of treatment. They also include efficacy treatments and safety and tolerability assessments. Topline results are expected in the first half of 2020 and will be submitted for presentation at scientific meetings.
The sponsors also completed enrollment in a randomized, double-blind placebo-controlled study of ISC 27864, three doses of the oral mPGES-1 antagonist administered once-daily—evaluated in adult patients with moderate osteoarthritic pain on the knee and/or hip. A total of 624 patients were randomized at sites in India. The primary endpoint being evaluated is the mean change from baseline in the Western Ontario and McMaster’s University Osteoarthritis Index pain subscale (WOMAC-PS) at the end of 12 weeks of treatment. Additional efficacy endpoints as well as safety and tolerability are being assessed. Data are also being collected for biomarkers that may demonstrate differentiation of ISC 27864 action from that of non-steroidal anti-inflammatory drugs (NSAIDs) and selective cyclooxygenase inhibitors (COX-2s). Topline results are expected in the first half of 2020 and will be submitted for presentation at scientific meetings.
Who is Ichnos Sciences?
Ichnos Sciences is a spinoff from generic drug maker Glenmark Holdings. Based in New Jersey, they have additional teams in Switzerland and India. In an attempt to focus on innovation and value building, they sought to have a new company not connected to the more traditional, generic company Glenmark.
The new spinoff has approximately 350 employees and has three new biological entities (NBE) and two new chemical entities (NCE) in various stages of development across oncology, autoimmune disease and pain. The immune-oncology biologics pipeline is developed through their proprietary BEAT® (Bispecific Engagement by Antibodies based on the T cell receptor) platform.