Sunstone Life Science Fund II portfolio company Orphazyme announced today that the first two patients have been dosed with arimoclomol in the Phase III ‘AIDNPC’ Niemann-Pick disease type C clinical trial programme.
The first two patients in the NPC-002 Interventional Study of the AIDNPC clinical programme were enrolled at the Rigshospitalet site in Copenhagen, Denmark, marking a key milestone in the development of a new treatment option for Niemann-Pick disease Type C (NP-C) patients.
Dr. Thomas Hecht and Dr. Mathieu Simon join Board; Dr. Hecht appointed Chairman
Sunstone Life Science Ventures Fund II portfolio company VAXIMM AG, a Swiss-German biotech company focused on developing oral T-cell immunotherapies, today announced the election of Thomas Hecht, MD, and Mathieu Simon, MD, as new members to its Board of Directors. In addition, Dr. Hecht has been appointed as Chairman of the Board, taking over from Dr. Klaus Breiner, who will continue his role in the company as Vice-Chairman.
Funding to Take Lead Compound Through to Product Approval and Development of Pipeline Assets
F2G Ltd, the UK-based antifungal drug discovery and development company, today announced that it has raised $60 million in financing to develop its pipeline of novel therapies to treat life threatening invasive fungal infections. The round was led by Sectoral Asset Management, with participation from Novo A/S, Aisling Capital and Brace Pharma Capital. Existing investors Advent Life Sciences LLP, Novartis Venture Fund, Sunstone Capital and Merifin Capital each participated in the round.
Sunstone Life Sciences Fund II portfolio company Orphazyme has received a “Study May Proceed” letter from the FDA on Orphazyme’s protocol for arimoclomol as a new treatment for Niemann-Pick disease type C (NP-C), the AIDNPC intervention study. This makes the US Investigational New Drug Application (IND) effective, complementing the corresponding European Clinical Trial Application (CTA) submitted for the same protocol.
Orphazyme runs an international, multi-centre, double-blind intervention study enrolling approximately 46 NP-C patients to be treated with three daily oral doses of arimoclomol or placebo. The objective of the study is to determine the efficacy and safety of arimoclomol in the treatment of NP-C.
Sunstone Life Science Fund I portfolio company Zealand announced today that the Endocrinologic and Metabolic Drugs Advisory Committee of the US Food and Drug Administration (FDA) has discussed lixisenatide and iGlarLixi for the treatment of adults with type 2 diabetes. Following the discussions, the Advisory Committee members voted 12 to 2 (with 1 non-vote) to recommend approval of the New Drug Application (NDA) for iGlarLixi in the US. The Advisory Committee was not asked by the FDA to vote on the approval of the NDA for lixisenatide.