Orvepitant

Patients who have the rare and fatal lung disorder idiopathic pulmonary fibrosis (IPF) have an uncontrolled and persistent cough that’s unresponsive to any therapies. NeRRe Therapeutics has clinical data suggesting its experimental drug reduces cough frequency and it has raised £20M (about $27.6 million) to see if the therapy can help the coughing of IPF patients. The Stevenage, U.K.-based company describes the new funding announced Wednesday as a Series B2 financing round. It plans to apply the cash toward the drug, orvrepitant, and clinical testing that’s planned for patients diagnosed with IPF. IPF is a form of fibrosis affecting the lungs. The disorder causes thickening and hardening of connective tissue, which in turn leads to scarring of the lungs. There is no cure, other than a lung transplant. Treatment is mainly managing the symptoms, though several biotechs have entered clinical trials testing drugs intended to addressing mechanisms that drive fibrosis. That’s not what NeRRe is pursuing. The company aims to address the persistent coughing that IPF patients experience as their disease progresses. Orvepitant is a small molecule designed to block the neurokinin 1 (NK-1) receptor. NK-1 inhibitors are already available for preventing nausea and vomiting. According to NeRRe, dysfunction of this receptor is also associated with the neural hypersensitivity that leads to chronic cough. Blocking NK-1 is intended to reduce the hypersensitivity underlying chronic cough. Nerre’s planned Phase 2 study in IPF patients is a second go-around for orvepitant, which the company initially studied as a treatment for chronic cough that is resistant to treatment. That placebo-controlled Phase 2 study enrolled 319 patients who were given the once-daily pill for 12 weeks. In results reported in 2019, orvepitant failed to achieve the main goal, at week 12, of reducing cough frequency while patients were awake. Despite failing the clinical trial, NeRRe pointed to other measures as showing improvement in chronic cough symptoms, including cough severity and urge to cough. On its website, NeRRE says that at 30 mg, the highest dose tested, the data trended toward showing significance in patients who had higher cough frequencies at the beginning of the study. Since that study, other clinical research in chronic cough has shown similar results. It’s in that context that NeRRe plans to proceed with Phase 2 testing in patients with IPF, a disease characterized by a high frequency of coughing. NeRRe is a spinout of GlaxoSmithKline. All of the biotech’s drugs are NK inhibitors that originally came from the labs of the pharmaceutical giant. The new cash infusion for NeRRe comes nearly a year after its own spinout company, KaNDy Therapeutics, was acquired by Bayer for $425 million up front. KaNDy’s drug, now dubbed BAY3427080, is a potential treatment for the night sweats and hot flashes that are symptoms of menopause. The small molecule, designed to block the NK-1 and NK-3 receptors, is in mid-stage clinical testing. The new NeRRe funding was led by new investor Columbus Venture Partners and earlier investors Advent Life Sciences, Fountain Healthcare Partners, Forbion Capital Partners, OrbiMed and the UK Government’s Future Fund. NeRRe said most of the proceeds will go toward Phase 2 clinical development of orvepitant as a treatment for chronic cough associated with IPF. Photo credit: Jackie Niam, Getty Images