- AMG 899 or Obicetrapib to be developed by Netherlands-based company to be headed up by Dr. Michael Davidson and Dr. John Kastelein
- Obicetrapib, a potent ApoB and LDL-c lowering small molecule drug, will be tested in patients not well controlled on statins and statin-intolerant patients
- Pivotal Phase 3 studies in dyslipidemia planned to start in 2021
NewAmsterdam Pharma B.V. ("NAP") has acquired the rights to obicetrapib (AMG 899) from Amgen.
The new Company, spearheaded by Michael Davidson, MD (CEO) and John Kastelein, MD, PhD, FESC (CSO), is currently working with the U.S. Food and Drug Administration (FDA) on a comprehensive Phase 3 clinical development program, including a cardiovascular outcome trial (CVOT) for obicetrapib. NAP is targeting for these trials to begin in 2021. To this end, the Company has received seed funding of approximately EUR 20M from Dutch investment firm Forbion as well as its Founders and will be raising a substantial financing round before year-end.
Obicetrapib is a cholesteryl ester transfer protein (CETP) inhibitor which targets Apolipoprotein B (ApoB) and low-density lipoprotein cholesterol (LDL-c) in the body. Obicetrapib is being developed for patients who are not well controlled on statins and patients who are statin-intolerant. Approximately 32 million people globally have statin-associated side effects or as a result of side effects, have discontinued their statin therapy.1
A Phase 2b study called TULIP, published in The Lancet showed that obicetrapib significantly reduced the number of ApoB-containing particles that constitute LDL-c and was well-tolerated in patients with mild dyslipidaemia.2 The randomized, double-blind, placebo-controlled study tested the drug in 364 patients to assess the safety, tolerability, and efficacy of the potential therapy.
In 2017, Amgen decided to discontinue the internal development of obicetrapib for strategic reasons and pursue out-licensing opportunities. Forbion believes that this drug could address very substantial unmet medical needs and therefore initiated conversations with Amgen to continue developing the asset. For this purpose, it has established NewAmsterdam Pharma B.V.
Financial terms of the acquisition of obicetrapib by NAP from Amgen were not disclosed.
Sander Slootweg, Managing Partner at Forbion commented:
"NewAmsterdam Pharma constitutes a very attractive investment opportunity, as obicetrapib has the potential to address the huge and poorly served patient segment of patients at risk of cardiovascular disease, currently not well controlled on statins or those even completely statin-intolerant. With over 30 million patients meeting these criteria, we believe that obicetrapib has mega-blockbuster sales potential. For this reason, we were able to attract a top founder team with Michael Davidson MD as CEO, who recently sold his previous company Corvidia Therapeutics, Inc. to Novo Nordisk and John Kastelein as CSO, after selling his previous company Staten Biotech to the same Novo Nordisk, in an option structure."
Michael Davidson, CEO of NewAmsterdam Pharma added:
"As we know today, the real culprit of heart disease is ApoB particle numbers. Obicentrapib being a highly potent small molecule, it holds great potential as a powerful tool to lower ApoB in patients, who otherwise cannot tolerate statin therapy. Phase 2b testing of obicetrapib has shown us very promising results with regard to patient tolerance, which we look forward to further examine in this next phase of research."
John Kastelein, CSO of NewAmsterdam Pharma concluded:
"In my opinion, obicetrapib is a best-in-class CETP inhibitor. From the Phase 2b trial in nearly 400 patients, we observed an average LDL-C lowering of 45% at a 5 mg daily dose, with a clean safety profile and excellent tolerability. A key lesson from previous Phase 3 studies with other CETPi molecules is not to combine CETPi with high-dose statins, because of an observed interaction. This makes obicetrapib an ideal drug for statin-intolerant patients and those not well controlled on maximally tolerated dose of statins. We have devised a comprehensive clinical development plan, including a CVOT, to show all favorable attributes of obicetrapib."
Notes to Editors:
About NewAmsterdam Pharma
Founded in 2019, NewAmsterdam Pharma is a privately held, clinical stage company focused on the research and development of transformative therapies for cardio-renal diseases. Its mission is to improve patient care in populations where traditional therapies are not tolerated or have been unsuccessful. In April 2020, NewAmsterdam acquired Dezima Pharma from Amgen, including all rights for obicetrapib (formerly AMG 899, now TA-8995) a selective cholesteryl ester transfer protein (CETP) inhibitor. The Company is investigating obicetrapib as a preferred ApoB and LDL-c lowering therapy for patients with statin intolerance or for patients with ASCVD/FH on the maximally tolerated dose of statin therapy. NewAmsterdam Pharma is headquartered in Naarden, The Netherlands.
For more information, please visit: www.newamsterdampharma.com
About Forbion
Forbion is a dedicated life sciences venture capital firm with offices in The Netherlands, Germany and Singapore. Forbion invests in life sciences companies that are active in the (bio-) pharmaceutical space. Forbion's investment team has built an impressive performance track record since the late nineties with successful investments in over 66 companies. Forbion manages well over EUR 1.25 billion across ten funds. Forbion is a signatory to the United Nations Principles for Responsible Investment. Besides financial objectives, Forbion selects investments that will positively affect the health and well-being of patients. Its investors include the EIF, through its European Recovery Programme (ERP), LfA, Dutch Venture Initiative (DVI), AMUF and EFSI facilities and KfW Capital through the Programme, "ERP Venture Capital Fondsinvestments". Forbion operates a joint venture with BGV, the manager of seed and early-stage funds, especially focused on Benelux and Germany. For more information, please visit: www.forbion.com.
1 Zhang, Ann Intern Med 2014
2 Hovingh GK, Kastelein JP, van Deventer SJH, Round P, Ford, J, Saleheen D, et. al. Cholesterol ester transfer protein inhibition by TA-8995 in patients with mild dyslipidaemia (TULIP): a randomised, double-blind, placebo-controlled phase 2 trial. The Lancet 2015.386(9992): 452-460. DOI: https://doi.org/10.1016/S0140-6736(15)60158-1
View source version on businesswire.com: https://www.businesswire.com/news/home/20200825005160/en/
Contacts:
NewAmsterdam Pharma
McDougall Communications on behalf of NewAmsterdam Pharma
Elizabeth Harness, P: +1 585-435-7379, elizabeth@mcdougallpr.com
Christopher Knospe, P: +1 716-440-5580, chris@mcdougallpr.com
Forbion
Sander Slootweg, Managing Partner
P: +31 (0) 35 699 30 00
Instinctif Partners (media for Forbion)
Melanie Toyne-Sewell Genevieve Wilson Kiki Zaccagnini
P: +44 207 457 2020
E: forbion@instinctif.com
