Immune Regulation announces positive results from Phase 1 clinical trial of IRL201104

Immune Regulation Ltd. (‘Immune Regulation’ or the ‘Company’, formerly known as Peptinnovate), a biopharmaceutical company developing “first in class” immune-resetting therapies for asthma and other inflammatory diseases, announces positive results from a Phase 1 study of its lead compound IRL201104 (‘1104).

  • Confirmed clean safety profile
  • No serious or severe adverse effects
  • Primary endpoints of safety and pharmacokinetic data achieved

 

Study C1104-001 was a First Time in Human, randomised, double blind, placebo controlled, parallel group study in healthy volunteers and patients with asthma to assess the safety, tolerability and pharmacokinetics of single ascending and repeat doses of ‘1104.

The Phase 1 trial recruited 94 subjects, including 16 mild asthmatics, administered with ‘1104 as a single ascending dose up to 8mg or repeat doses of 2mg on a single day or placebo and then followed for 21 days.

The Phase 1 trial confirmed the clean safety profile of ‘1104 seen in pre-clinical studies, with the drug having a side effect profile comparable to placebo; the majority of events were classed as mild and no serious or severe adverse events were reported. No dose limiting safety or tolerability was reported in the study and no injection site reactions were seen in the small cohort of healthy subjects receiving subcutaneous (s.c.) dosing. Pharmacokinetic data from the trial showed exposure to ‘1104 was in-line with expectations based on pre-clinical work and was similar in both healthy volunteers and mild asthmatics.

Based on these successful Phase 1 results, Immune Regulation is moving forward with a Phase 2a proof of concept study, due to commence in the second half of 2019.

Richard Nagle, CEO of Immune Regulation, commented,
“These results for ‘1104 are a great validation of the safety of our immune-resetting platform. It is exciting to now be embarking upon the next stage of development and the data from this study will inform the preparations and protocols for our Phase 2a trial starting next year.”

Details of the Phase 1 (C1104-001) study

  • Single site study conducted by Parexel in the UK
  • 78 healthy volunteers (HV) and 16 mild asthmatics were enrolled
  • The trial advanced through eleven cohorts of HV (44 active, 22 placebo) with a dose range of 0.02ng to 8mg, administered as a single i.v. bolus injection. Mild asthmatic patients received single i.v. doses of placebo, 2mg or 8mg (10 active, 6 placebo)
  • 6 HV (4 active, 2 placebo) received 2mg via a s.c. injection
  • 6 HV (4 active, 2 placebo) received 3x2mg doses 2 hours apart
  • Subjects were followed over 21 days post dose
  • Primary endpoints were safety and pharmacokinetic data

 

Enquiries
Immune Regulation
Richard Nagle, CEO
+44 (0)7809 525267
info@immuneregulation.com

Instinctif Partners
Melanie Toyne-Sewell / Rozi Morris
+44 (0)20 7457 2020

About Immune Regulation
Formerly known as Peptinnovate Ltd, Immune Regulation is a drug development company developing ‘first in class’ immune resetting therapies for asthma and other chronic inflammatory diseases. The products under development by Immune Regulation have the potential to significantly advance the control and management of a range of chronic inflammatory diseases, with the potential for immune regulation, disease modification and remission.

About IRL201104
IRL201104, is uniquely safe and efficacious demonstrating immunoregulatory activity in a number of preclinical models. It has successfully completed Phase 1 clinical development and has the potential to be the first Immune Resetting Asthma Drug (IMRAD).

26 November 2018

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Glen Giovanetti

Non-Executive Director

Glen Giovanetti has more than 35 years of experience in strategy and operational leadership in the life science industry as well as in financial governance, risk and reporting as EY’s Global Biotechnology Sector Leader and Life Sciences Sector Leader. He currently serves on the Board of Directors of Life Science Cares, Teon Therapeutics and XW Pharma.

Marla S. Persky

Non-Executive Director

Marla S. Persky currently serves as the chief executive officer and president of WOMN LLC. She has more than 25 years of international senior business and legal experience in the pharmaceutical industry having held numerous business and legal positions at Boehringer Ingelheim and Baxter International. She currently serves on the Boards of Directors of Xeris Pharmaceuticals, YGEIA Consulting Group, Primary Stages, World Neighbors and A Better Chance in Ridgefield.

Dora Rau

Senior Vice President, Quality

Dora Rau brings 25 years of experience in development and commercial operations for drugs, biologics, devices and combination products to the team. She has held numerous executive-level quality positions, with expertise in building quality systems and in leading teams to attain successful regulatory authority inspection outcomes and product approvals.

Jonathan Gold

Chief Financial Officer

Over the last 25 years, Jonathan Gold has been an institutional venture capitalist, a public fund manager, a founder, an operating executive, and a board member for companies across sectors including life sciences. In those roles, he was active in the development, financing and mergers and acquisitions for numerous public and private companies.

Team Members

Michael Albisser

Non-Executive Director​

Michael is a partner of Metellus, a Zurich and London-based venture capital firm investing in technology and life sciences with ground-breaking potential. Having more than 25 years of experience in the finance area he is responsible for finance, tax, and deal structures. He serves on the board of various venture-backed companies.

Dr. Isaac Cheng, m.d.

Non-Executive Director

Dr. Isaac Cheng is currently an investment professional at Morningside, a venture capital and private equity institution based in Boston USA, and Shanghai China. Dr. Cheng focuses primarily on biopharmaceutical and healthcare investments. He has served on numerous public and private company boards.

Peter Greenleaf

Chairman

Peter Greenleaf currently serves as the chief executive officer (CEO) and member of the Board of Directors of Aurinia, (NASDAQ: AUPH / TSX: AUP), an autoimmune therapeutics company. He has held several other CEO and chairman roles. He is also currently a member of the Board of Directors of Antares Pharmaceuticals, Inc. (NASDAQ: ATRS) and Chairman of the Board of Directors of Biodelivery Sciences International, Inc. (NASDAQ: BDSI).

Marylyn Rigby

VP of Marketing and Investor Relations

Marylyn Rigby is an experienced pharmaceutical, biotech, and drug delivery professional. In addition to her expertise in marketing, public and investor relations, she has a successful track record with business development, licensing, public and private equity financing, strategy and other key corporate functions.

Nancy Vinh

VP of Clinical Operations

Nancy Vinh brings over 20 years of experience in managing early and late phase, international clinical trials for drugs, biologics, cell therapy and combination products across a wide range of therapeutic areas to the team. She has served as head of clinical operations and led registrational and label expansion trials execution.

Team Members

Dr. Clare Burgess

Chief Development Officer

Dr. Clare Burgess has 24 years of experience in clinical drug development as a pharmacologist and has worked across a wide range of therapeutic areas within the pharmaceutical industry. She has held multiple leadership roles and has led multidisciplinary teams across the world.

Jeff Myers, m.d., ph.d

Chief Medical Officer

Jeff Myers, M.D., Ph.D., has 20 years of experience in medical affairs, regulatory and clinical development within the biopharmaceutical industry, with focuses on cardiovascular, pulmonary, oncology, and inflammatory diseases.

Before entering the industry, he practiced as a congenital cardiac surgeon and served as the chief of pediatric cardiac surgery at Massachusetts General Hospital and as Associate Professor of Surgery at Harvard Medical School.

Team Members
  • Nancy Vinh: Vice President of Clinical Operations

Dr. Roly Foulkes

Chief Scientific Officer

A true drug discoverer, Dr. Roly Foulkes has 25 years of experience building and delivering innovative therapeutic portfolios within the immunology and inflammatory disease space. He has a strong record advising small and medium sized immunology biopharma companies in developing competitive therapeutic strategies and bringing new innovative molecules to the clinic.

Team Members

Jones w (woody) Bryan, ph.d.

Chief Business Officer

Jones (Woody) Bryan, Ph.D., brings almost 30 years of experience in the healthcare industry to the team, having led successful business development operations in both private and public pharma and biotech companies.

Team Members

Perry Calias, ph.d.

Chief Operating Officer

Perry Calias, Ph.D., brings over 25 years of experience in pre-clinical and clinical development, CMC and global regulatory submissions across the drug and device sectors of healthcare. He has held numerous executive positions leading clinical and non-clinical operations, with a strong focus on diseases of the central nervous system and rare diseases.

Team Members

Jonathan Rigby, mba

Group Chief Executive Officer

As employee #1 of Revolo Biotherapeutics in the US, Jonathan Rigby has led the company through substantial and rapid growth. He brings three decades of experience creating value and opportunities for companies in the pharmaceutical, biotech and drug delivery technology industry.

Team Members
  • Carrie Vincent: Director, HR & Senior Executive Administration
  • Dr. Jones W. (Woody) Bryan: Chief Business Officer
  • Dr. Roly Foulkes: Chief Scientific Officer
  • Jonathan Gold: Chief Financial Officer
  • Jeff Myers, MD: Chief Medical Officer
  • Marylyn Rigby: VP Marketing & Investor Relations
  • Dr. Perry Calias: Chief Operating Officer