San Mateo, Calif, Nov 14, 2018 – Attenua, Inc., a clinical-stage biopharmaceutical company focused on developing novel medicines to treat cough, today announced that the first patient has been treated in a Phase 2 clinical trial in chronic cough with bradanicline (formerly known as ATA-101), its lead compound.
“Within just six months of our initial Series A funding, Attenua has successfully filed an Investigational New Drug (IND) application, received Institutional Review Board (IRB) approval at 17 clinical trial sites, manufactured drug and launched a Phase 2 clinical trial with bradanicline in chronic cough,” said Michael Kitt, M.D., Chief Executive Officer of Attenua. “This is a testament to our experienced team and focused execution at top-tier clinical trial sites.”
The Phase 2 randomized, double-blind, dose-escalation, crossover study will test the efficacy and safety of bradanicline in up to 49 patients with refractory chronic cough. Refractory chronic cough is defined as a cough that persists for eight weeks or more. Patients will receive daily either escalating doses of drug or matching placebo for three weeks, followed by a 14-day washout period, before crossing over to the opposite treatment for three weeks. Cough frequency will be assessed with an objective cough recording device every seven days. For more information, please visit www.clinicaltrials.gov.
“We look forward to testing bradanicline in this proof-of-concept study, which focuses on a new mechanism of action that is believed to play a key role in chronic cough,” said principal investigator Jacky Smith, MD, Professor of Respiratory Medicine at the University of Manchester, UK.
Attenua plans to conduct additional clinical trials to test the safety and efficacy of bradanicline in 2019.
Bradanicline HCl is a highly selective agonist of the α7 subtype of neuronal nicotinic receptors (NNRs). α7 NNR activation has been shown to modulate levels of several neurotransmitters in the central nervous system, including gamma aminobutyric acid (GABA). An α7 NNR-dependent activation of GABAergic interneurons in the brainstem is the proposed mechanism of action for bradanicline in cough. Currently, the most commonly used antitussive medicines are opioids, but any benefits provided by these agents is offset by their significant safety liabilities and abuse potential. Bradanicline is in development as a centrally acting antitussive, which holds promise for cough relief and significant social benefits and safety for patients with cough.
About Chronic Cough
Chronic cough remains a significant unmet need affecting more than 2.5 million people in the U.S. alone. Cough can be classified as acute, lasting for up to three weeks, subacute, lasting from three to eight weeks or chronic, lasting for more than eight weeks. While underlying causes may contribute to cough in some of these patients (such as gastro-intestinal reflux disease, asthma or chronic obstructive pulmonary disease), cough still remains a significant problem for many patients even with treatment for these underlying causes.
Attenua is a clinical-stage biotechnology company developing novel medicines for the millions of patients who suffer from chronic respiratory disorders such as chronic cough. Cough is a medical problem for which no new drugs (NMEs/NCEs) have been approved in the U.S. since 1958. No medication is approved for treating chronic cough. Attenua completed a $35 million Series A financing in April 2018, led by Omega Funds with participation from leading health care investors including Abingworth, OrbiMed and Redmile Group LLC. For further information, please visit www.attenua.com.
Source: Attenua, Inc.
Posted: November 2018
Source: Read Full Article