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ApcinteX Ltd, a biotech company spun out of the University of Cambridge, announces the first dose of its investigational drug SerpinPC in a haemophilia patient following successful completion of dose escalation in healthy volunteers.

Haemophilia affects approximately half-a-million people worldwide, the vast majority of whom have limited access to treatment. The unique mode of action of SerpinPC supports monthly subcutaneous prophylactic dosing and a favourable safety profile. 

AP-0101 is a phase 1/2 clinical trial with the single ascending dose which began in healthy volunteers (Part 1A) and is now continuing in patients with severe haemophilia at doses predicted to provide clinical benefit (Part 1B). The primary purpose of the trial is to assess the safety and pharmacokinetic properties of SerpinPC, with reduction in bleeding episodes as an exploratory endpoint. 

Four cohorts of three patients are planned in Part 1B, which is taking place in Moldova where most bleeds go untreated due to scarcity of replacement factor. The trial is open to patients with severe haemophilia A and B, with or without inhibitors. Subjects who participate in Part 1B will have the option to continue into the six-month, multiple dosing Part 2 of the study. A second site in Georgia will be opened to support Part 2 which is scheduled to begin this summer.

Five cohorts of healthy volunteers were successfully dosed with SerpinPC in Part 1A of the study, which was conducted in the UK, four by IV infusion and one by subcutaneous injection. The final cohort finished dosing on the 5th of February this year. There were no SerpinPC related adverse events and no elevation in D-dimer levels, an early sign of excessive thrombin generation associated with other investigational haemophilia treatments. 

The company’s Chief Medical Officer, Trevor Baglin, said: 

“We are delighted that Part 1A is finished and that SerpinPC will now be administered to haemophilia patients, particularly in a setting where the case of need is palpable. It’s important to remember that although there are new treatments available, most people with haemophilia are not benefitting at the moment. It is our hope that SerpinPC will provide a once-monthly subcutaneous prophylactic treatment for all.”

About ApcinteX

ApcinteX Ltd is a virtual biotech company (www.apcintex.com) spun out of the laboratory of Professor Jim Huntington at the University of Cambridge, with Cambridge Enterprise, in 2014. It closed a £14 million series A financing round in 2016 which was led by Medicxi and IP Group. For enquiries, please contact [email protected].
About Cambridge Enterprise

Part of the University of Cambridge, Cambridge Enterprise supports academics, researchers, staff and students in achieving knowledge transfer and research impact. We do this by helping innovators, experts and entrepreneurs use commercial avenues to develop their ideas and expertise for the benefit of society, the economy, themselves and the University. For more information, please visit: www.enterprise.cam.ac.uk.

About Medicxi 

Medicxi is a European venture capital firm with the mission to create and invest in companies along the full drug development continuum. Medicxi was established by the former Index Ventures life sciences team, which has been active for over 20 years, and invests in both early and late-stage assets with a product vision that can fulfil a clear unmet need. GSK, Johnson & Johnson Innovation – JJDC, Inc., Novartis and Verily (an Alphabet company) have invested in Medicxi funds. Please see www.medicxi.com for more information. 

About IP Group

IP Group is a leading intellectual property commercialisation company which focuses on evolving great ideas, mainly from its partner universities, into world-changing businesses. The Group has pioneered a unique approach to developing these ideas and the resulting businesses by providing access to business building expertise, capital (through its 100%-owned FCA-authorised subsidiaries IP Capital and Parkwalk Advisors), networks, recruitment and business support. IP Group has a strong track record of success and its portfolio comprises holdings in early-stage to mature businesses across life sciences and technology. IP Group is listed on the Main Market of the London Stock Exchange under the code IPO. For more information, please visit our website at www.ipgroupplc.com.