On March 10, 2020 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported that scheduled in-person presentation at the Barclays Global Healthcare Conference in Miami Beach was changed by conference organizers to a webcast only, as the conference has been reconfigured (Press release, Ligand, MAR 10, 2020, View Source [SID1234555367]). The webcast will take place as previously scheduled at 2:35 p.m. ET and is available here. Conference one-on-one investor meetings have been moved to telephone calls, and the new slides Ligand will be using during those meetings have been posted to www.ligand.com.
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The new slides contain recent pipeline and business updates, including:
Palvella Therapeutics completed enrollment in the Phase 2/3 pivotal study of PTX-022 for treatment of pachyonychia congenita, with topline data expected in Q4. PTX-022 is a Fast Track-designated program.
Gloria Pharmaceuticals, Ligand’s partner for the OmniAb-derived anti-PD-1 antibody zimberelimab in China, announced they are filing for marketing authorization in China based on positive Phase 2 data in classical Hodgkin’s lymphoma. This program joins C-Stone’s CS1001 as another OmniAb antibody that may be approved in 2020. OmniAb-derived zimberelimab is also in development in the U.S. by partner Arcus Biosciences.
In addition to zimberelimab, Ligand’s portfolio of partnered programs includes six new products that could launch by the end of 2022 including Takeda’s pevonedistat, Retrophin’s sparsentan, Eisai’s parempanel-IV, Palvella’s PTX-022, Xi’an Xintong’s Pradefovir and C-Stone’s CS-1001. Additional partnered programs could launch in this timeframe as well.
Retrophin announced enrollment of the first 190 patients in its pivotal Phase 3 DUPLEX study of Sparsentan in Focal Segmental Glomerulosclerosis. Topline efficacy data from the 36-week proteinuria endpoint analysis of the trial are expected in the first quarter of 2021.
Nucorion Pharmaceuticals completed filing of an IND for its novel liver-targeted hepatitis B program NC0-1010, obtained FDA acceptance of the IND and is on track for initiation of a Phase 1 clinical trial in the U.S in March. This is the first clinical-stage program to leverage Ligand’s novel, internally developed LTP Technology Platform.
Ligand continues to support Captisol orders from partners related to remdesivir, an investigational product candidate being actively assessed in Phase 2 and Phase 3 clinical studies to treat COVID-19, with the first studies expected to be completed in April.
"2020 is off to an excellent start, with a good flow of news and updates from our partnered portfolio. We are facing the most substantial calendar of partner events in our history and see the potential for several major new product launches over the next couple of years," said John Higgins, Chief Executive Officer of Ligand. "Our OmniAb business is doing very well, with two antibody-based drugs filed or expected to be filed for potential approval."
"We have also been very active working with partners to meet their Captisol needs to formulate clinical supplies of the antiviral drug remdesivir, which is being studied as a potential treatment for COVID-19," he added. "Our team has made substantial progress over the past few weeks working with partners to provide supply-chain support that was not anticipated at the start of the year."
About Captisol
Captisol is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Captisol was invented and initially developed by scientists in the laboratories of Dr. Valentino Stella, University Distinguished Professor at the University of Kansas’ Higuchi Biosciences Center for specific use in drug development and formulation. This unique technology has enabled several FDA-approved products including Amgen’s KYPROLIS, Baxter International’s NEXTERONE, Acrotech Biopharma L.L.C.’s and CASI Pharmaceuticals’ EVOMELA, Melinta Therapeutics’ BAXDELA and Sage Therapeutics’ ZULRESSO. There are many Captisol-enabled products currently in various stages of development.