ATN-249 / Attune Pharma - LARVOL DELTA

Advent of oral medications for the treatment of hereditary angioedema. (PubMed, Clin Transl Allergy) - "Substantial advances have been made in the development of oral treatments for HAE. These treatments have the potential to improve and optimize clinical outcomes, satisfaction, and quality of life among patients with HAE."

Journal • Review • Cardiovascular • Complement-mediated Rare Disorders • Dermatology • Genetic Disorders • Hereditary Angioedema • Mood Disorders • Pain • Psychiatry

Kallikrein inhibitors for angioedema: the progress of preclinical and early phase studies. (PubMed, Expert Opin Investig Drugs) - "ATN-249 is an oral drug that has shown promising results in preclinical and Phase I studies, and good tolerability in the prophylactic treatment of attacks. KVD900 is also an oral agent developed for the on-demand treatment of HAE attacks...The third drug, IONIS-PKKRx, is an antisense oligonucleotide targeting plasma prekallikrein mRNA...STAR-0215 is a long acting anti-activated kallikrein monoclonal antibody...Lastly, NTLA-2002 is an investigational gene-editing therapy. The targeted treatment of the dysregulated kinin-kallikrein system with specific inhibitors is promising for the prevention of angioedema attacks. Ongoing phase III studies will provide further insight into the efficacy and long-term safety of these novel therapies, potentially expanding treatment options for HAE treatment."

Journal • Preclinical • Review • Cardiovascular • Complement-mediated Rare Disorders • Genetic Disorders • Hereditary Angioedema

[VIRTUAL] Detecting Oral Kallikrein-Targeting Therapy through Triggered Contact Activation: A Phase I Study (ISTH 2020) - "The considerable inter-individual variability in triggered PKa activity and cHK generation argues against a generalized cutoff value for these parameters in C1INH-HAE management and motivates development of personalized approaches. These assays are useful to monitor the biological activity of the oral PKa inhibitor ATN-249 in plasma."

P1 data • Cardiovascular • Complement-mediated Rare Disorders • Hereditary Angioedema

Detecting oral kallikrein-targeting therapy through triggered contact activation: a phase I study. (PubMed, J Allergy Clin Immunol) - "The oral kallikrein inhibitor ATN-249 is a candidate therapy for hereditary angioedema. We demonstrate the biological activity of this compound in plasma samples from a phase I study through investigation of ex vivo triggered contact activation."

Journal • P1 data

Attune Pharmaceuticals announces positive phase 1 results for ATN-249, an oral plasma kallikrein inhibitor for the treatment of HAE (GlobeNewswire) - P1, N=48; "Attune Pharmaceuticals...today announced positive results from the first in human studies evaluating ATN-249...for the treatment of Hereditary Angioedema (HAE). The data were presented by Ira Kalfus, M.D., chief medical officer of Attune, as a poster presentation at the Western Society of Allergy, Asthma and Immunology (WSAAI) 2019 Annual Scientific Session....'We expect to complete the multiple ascending dose trial shortly and plan to rapidly advance the program to a Phase 2 trial.'...Once-daily dosing of ATN-249 was safe and well tolerated at all studied doses (50mg to 800 mg) in healthy volunteers. There were no moderate or severe adverse events with all adverse effects being mild..."

New P2 trial • P1 data

Attune Pharmaceuticals announces $23M series B financing to advance ATN-249 for the treatment of HAE (GlobeNewswire) - "Attune Pharmaceuticals...today announced the completion of a $23 million Series B financing....'This financing brings together a syndicate of investors with a deep understanding and long history of supporting companies that develop novel HAE therapeutics. Building upon our recently announced positive Phase 1 data, the Series B enables Attune to rapidly advance our lead clinical program through Phase 2 while also providing capital for our other pre-clinical discovery programs.'"

Financing