SAN CARLOS, CA, USA I January 19, 2016 I Allakos, Inc., today announced it has successfully completed dosing in the Phase 1 clinical trial of AK001 in healthy volunteers and subjects with atopic disease. AK001 is a therapeutic antibody intended for the treatment of severe allergic diseases and diseases characterized by excess activity of mast cells and eosinophils. The randomized, double-blind, placebo-controlled, single-ascending-dose study enrolled 34 subjects to evaluate the safety, tolerability and pharmacokinetics of AK001 in a range of potentially active doses and to obtain early signals of pharmacodynamic activity.

Allakos has also strengthened its management team with the appointment of three experienced executives.

  • Simon Greenwood, Ph.D., Allakos’s chief business officer, has over 20 years of experience in the healthcare industry. Prior to joining Allakos, he was investment director for the Roche Venture Fund, where he led investments in Allakos, 23andMe, Biodesy, CytomX, DVS, Epic Sciences, Horizon Discovery, Maculogix, ProActa and Stratos. Prior to the Roche Venture Fund, Simon was the head of GenenFund, Genentech’s corporate venture fund, and he also held roles in research and business development at Genentech. Simon holds a Ph.D. in Genetics and Development from Columbia University College of Physicians and Surgeons, where he was a Fulbright Scholar.
  • Sally Bolmer, Ph.D., vice president of regulatory affairs and development for Allakos, has more than 25 years of experience in the biopharmaceutical industry. Prior to Allakos Sally was senior vice president of development and regulatory affairs at Human Genome Sciences, Inc. Before Human Genome Sciences, she was executive director for regulatory affairs at Centocor, Inc. In her career, Sally has secured approval for five first-in-class biologics, initiated INDs for over 50 indications, and submitted six BLAs for products including murine, chimeric and human antibodies, antibody fragments and fusion proteins. Sally received a bachelor of science in biochemistry from Brown University and a Ph.D. in biological chemistry from the Hershey Medical Center of Penn State University. She had a post-doctorate appointment in applied biological sciences at MIT and was an assistant research professor at Mount Sinai Medical Center in New York City.
  • Omer Siddiqui, vice president of clinical operations, has more than 15 years of leadership experience in clinical operations and drug development. He has successfully led clinical operations teams in planning and advancing drug candidates from pre-clinical through IND and proof of concept, up to Phase 3 life cycle investment stage. Prior to Joining Allakos, Omer was responsible for the Immunology, Infectious Disease, Neuroscience and Ophthalmology early development clinical operations group at Genentech. Prior to joining Genentech, he was a senior director in the CNS group at INC Research, a contract research organization specializing in planning and executing drug development programs. Omer received his undergraduate degree in biology from the University of Western Ontario in Canada.

Quotes

Christopher Bebbington, D.Phil., chief executive officer and co-founder of Allakos, said, “AK001 is the first of Allakos’s antibodies to enter the clinic. As such, the completion of dosing in our Phase 1 clinical trial is an important milestone for Allakos. The addition of Simon, Sally and Omer brings additional leadership and experience to Allakos and we are pleased to have been able to attract these experienced executives to the management team.”

Alejandro Dorenbaum, M.D., chief medical officer of Allakos, said, “AK001 is a first-in-class antibody that works by a novel mechanism of action on mast cells and eosinophils. We look forward to continuing the clinical development of AK001 in patients with severe allergic and inflammatory diseases such as recurrent nasal polyposis and chronic obstructive pulmonary disease (COPD).”

About AK001

AK001 is a therapeutic antibody that targets a receptor present on eosinophils and mast cells. Binding of antibody to this receptor causes inhibition of mast cell activity and selective depletion of activated eosinophils. AK001’s action is highly specific to mast cells and eosinophils and has potential to be of benefit in a wide spectrum of conditions where these cells are involved. AK001 has demonstrated activity in proprietary pre-clinical models of severe allergic diseases.

About Allakos

Allakos is a clinical-stage company developing antibodies that selectively target mast cells and eosinophils, important effector cells in a broad spectrum of allergic and inflammatory conditions and several rare proliferative diseases. The company’s lead antibodies are AK001 and AK002 intended for the treatment of severe allergic diseases and other diseases characterized by excess activity of mast cells and eosinophils. The company has raised a total of $47 million to-date in Series A financing from Novo Ventures, Alta Partners, RiverVest Venture Partners and the Roche Venture Fund.

SOURCE: Allakos