|VPM oversees clinical trial and translational project management – Positive Phase I data of client Memo Therapeutics AG|
|By: GlobenewsWire - 25 Jan 2023||Back to overview list
HANNOVER, Germany, Jan. 25, 2023 (GLOBE NEWSWIRE) -- Vakzine Projekt Management GmbH (VPM), a German drug development consultancy and service provider supporting small and medium pharma and biotech companies with its exceptional expertise spanning the complete pharmaceutical value chain from drug discovery to clinical development, marketing authorization and market access, today announced the successful completion of a clinical client project for Memo Therapeutics AG (MTx), Switzerland. The project included a Phase I clinical trial with AntiBKV, an antibody targeting BK polyomavirus (BKV) infection in renal transplant patients. VPM oversaw the clinical trial and performed translational project management, whereas the Australian cooperation partner and contract research organization (CRO) Accelagen managed the trial, yielding positive results, with all endpoints met.
In this phase I, single-blind, partially randomized, placebo-controlled clinical trial, 40 healthy adult volunteers were administered single and multiple ascending intravenous doses of AntiBKV (ClinicalTrials.gov: NCT05358106). No relevant adverse events were seen up to the highest dose of 2000 mg and pharmacokinetics were found to be normal and linear. MTx plans to submit an Investigational New Drug Application (IND) during the first quarter 2023 to initiate a multicenter study in the U.S..
Dr. Karsten Fischer, Chief Executive Officer of Memo Therapeutics AG, commented: “VPM has supported our drug development from the very start, throughout Phase I, and helped us to conclude our trial efficiently, cost-effectively and successfully. The broad expertise and commitment of VPM made the trial run smoothly, within budget and on time. As a next step we plan to initiate a multicenter study in the U.S.. For similar development projects in the future, we will continue to count on VPM’s support.”
CEO and Founder of Accelagen, Greg Plunkett, added: “We know VPM as trusted cooperation partner, and together we realized the efficient execution of this clinical program. We have seen that their expertise and strong collaboration facilitates fast and seamless development in all important geographies of the world. The outcomes we have achieved together exemplifies our shared values and commitment to making a difference to the future of healthcare.”
“Our work with Memo Therapeutics, especially on AntiBKV, has driven the transformation of a ground-breaking idea into a life-saving potential medication, based on the in-depth knowledge and experience of successful pharmaceutical development strategies across a broad range of indications within VPM. Furthermore, our reliable, internationally renowned CRO partner Accelagen supports us in our endeavors, with highly efficient trial and regulatory processes and international standards,” said Dr. Leander Grode, Managing Director of VPM. “By engaging with our expanding network of cooperation partners, we aim to increase our offerings in clinical trials and our commitment to supporting clients in their pipeline development and building value in their companies.”
BKV is a wide-spread virus persisting in approximately 80-90 % of the population. While clinically not relevant in healthy individuals, the virus is often reactivated in immunosuppressed patients. Reactivation has been shown to be a frequent cause of kidney transplant deterioration and rejection. AntiBKV is intended to provide an acute treatment, reduce the viral load below the detection limit and thus, for the first time, provide a causal treatment of polyomavirus-associated nephropathy.
About Memo Therapeutics AG
Dr. Leander Grode, CEO
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