Pfizer (PFE) has kicked off a Phase 2b study of vupanorsen (ANGPTL3) in statin-treated patients with elevated non-high-density lipoprotein cholesterol and triglycerides (TGs).
The study will evaluate the effectiveness of various doses of vupanorsen to determine potential future development. In the Phase 2a study, vupanorsen met the primary endpoint of significant reductions in TG levels and multiple secondary endpoints compared to placebo, with a favorable safety and tolerability profile.
Vupanorsen is an investigational antisense therapy being developed for potential cardiovascular risk reduction and severe hypertriglyceridemia. Vupanorsen is targeted to lower the production of angiopoietin-like 3 (ANGPTL3) protein, a key regulator of triglyceride and cholesterol metabolism, in the liver.
In November 2019, Pfizer announced a worldwide exclusive licensing agreement for vupanorsen with Ionis Pharmaceuticals (IONS) and its wholly owned subsidiary Akcea Therapeutics. Under the terms of the deal, the initiation of the Phase 2b study triggered a milestone payment of $75 million from Pfizer.
“Results from the Phase 2a study recently presented at the ESC Congress and published in the European Heart Journal, showed that antisense-mediated reduction of ANGPTL3 has the potential to address unmet needs in patients with atherosclerotic cardiovascular diseases,” said Sam Tsimikas at Ionis. “We look forward to seeing Pfizer advance the Phase 2b study and report results on this clinical program.”
The Phase 2b study will include the enrollment of 260 participants who are receiving a stable dose of a statin. The study will explore different vupanorsen doses and dose regimens versus placebo, with patients receiving either 80 mg, 120 mg or 160 mg every 4 weeks, or 60 mg, 80 mg, 120 mg or 160 mg every two weeks via subcutaneous injection.
Shares in Pfizer are down 7.6% year-to-date, but the analyst consensus currently rates the stock a cautiously optimistic Moderate Buy. That’s based on 3 Buy and 5 Holds over the last three months, with an average price target of $41.41 (14% upside potential).
Mizuho Securities analyst Vamil Divan recently reiterated a Buy rating on the stock with a $43 price target, saying that he continues to see upside from Pfizer’s COVID-19 vaccine candidate and, more importantly, the rest of its pipeline.
“While the atopic dermatitis market will likely be competitive, we believe Pfizer only needs to capture a modest amount of market share to make the product a billion-dollar blockbuster, given the substantial size of the market (60M patients globally),” Divan wrote in a note to investors. “In addition to the COVID-19 vaccine study, the company also expects to start a Phase 2/3 study in late 2020/early 2021 for an anti-viral candidate against the novel coronavirus with the hope of a regulatory submission in 2H21.” (See Pfizer stock analysis on TipRanks)
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