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Achillion Pharmaceuticals, Inc. ACHN announced that it has initiated a phase I study on its next-generation, oral, alternative pathway factor D inhibitor, ACH-5548. Interim data from the same is expected during the second half of 2018.
ACH-5548 is the third compound discovered and developed by Achillion from its complement factor D portfolio, which consists of another two such compounds, namely ACH-5228 and ACH-4471.
Factor D, an essential protein of the complement pathway is integral to the human innate immune system. Though this area has commercial opportunity, the complement-mediated space is highly crowded with many biotech companies working on to introduce these treatments to the market.
Achillion is focused on its factor D portfolio. The company is working on to develop oral inhibitors of complement Factor D. Targeted therapeutic areas include paroxysmal nocturnal hemoglobinuria (PNH), C3 glomerulopathy (C3G), immune complex membranoproliferative glomerulonephritis, atypical hemolytic uremic syndrome and dry age-related macular degeneration.
The phase I placebo-controlled trial administered single-ascending dose of ACH-5548 to healthy volunteers. Approximately, 28 patients are estimated to be enrolled in this assessment. The program’s primary endpoint is to evaluate the safety and tolerability while the secondary includes evaluations of pharmacokinetic, pharmacodynamic and examination of alternative pathway inhibition.
The company also aims at completing the phase I studies on its two next generation factor D inhibitors – ACH-5228 and ACH-5548 – in the fourth quarter of 2018.
Notably, the company’s lead candidate, ACH-4471, has shown clinically meaningful complement inhibition of factor D in PNH patients. The company plans to present results from a 14-day phase II study on ACH-4471 for the treatment of C3G during the third quarter of 2018 and post interim data from phase II clinical trials with longer-duration on ACH-4471 to address both C3G and PNH in the second half of 2018.
Achillion also anticipates to initiate another phase II study on ACH-4471 for evaluating the candidate in combination with Alexion’s ALXN Soliris for potentially long-term treatment of PNH patients, who are already being treated with Soliris.
Shares of Achillion have lost 0.7% year to date compared with the industry’s decline of 3.1%.
Achillion currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the same sector include Genomic Health, Inc. GHDX and Asterias Biotherapeutics, Inc. AST, both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Genomic Health’s earnings estimates have been revised 4.4% upward for 2018 over the past 60 days. The stock has soared 49.2% so far this year.
Asterias’ loss per share estimates have been narrowed by 7.9% for 2018 and 12.5% for 2019 over the past 60 days.
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