Certa Therapeutics Pty Ltd. is progressing antifibrotic agent FT-011 to phase III trials following positive results in a phase II trial that showed clinically meaningful improvements for more than 60% of patients with scleroderma in 12 weeks. “This was a short-term 12-week study, so to see such remarkable results so quickly was unexpected,” Certa CEO Darren Kelly told BioWorld. FT-011 targets a previously undrugged G protein-coupled receptor, and these early efficacy outcomes in scleroderma suggest potential for FT-011 to treat other indications in Certa’s pipeline, including diabetic retinopathy and other forms of chronic kidney disease.

Prospects better for HIF-PHI therapies after GSK approval?

The clearance Feb. 2 by the U.S. FDA of GSK plc’s daprodustat for anemia in patients with chronic kidney disease who are on dialysis raised hopes for would-be competitors in the same class. Regulators, following the lead of an advisory committee meeting, made daprodustat (branded Jesduvroq) the first oral hypoxia-inducible factor prolyl hydroxylase (HIF-PHI) inhibitor to reach the market. Another high-profile name in HIF-PHI is Akebia Therapeutics Inc., with vadadustat, for which an update is due soon on the company’s dispute resolution process, begun with the FDA last October after the agency turned thumbs-down on the drug.

BIO CEO 2023: Getting funded when there is too much inventory

The market downturn has left many biopharma companies searching for new ways to raise funds, with some eyeing venture capital (VC) as a potential resource to spin out programs into new companies. VC rounds in 2022 raised $22.16 billion for the industry, according to BioWorld data, representing the third best year, behind 2021’s $39.6 billion and 2020’s $28.2 billion. In contrast, IPOs and follow-on offerings are at their lowest levels in all recent years. As an ever-burgeoning list of innovative companies continuously vie for money, and as the macroeconomic environment changes, financial executives discussed on Feb. 6, the first full day of the BIO CEO 2023 conference in New York, ways for companies to keep their heads above water.

Stock market reacts to Idorsia’s second phase III trial failure with Pivlaz

Shares in Idorsia Ltd. plummeted by around 14% Feb. 6 as the company announced that its phase III REACT trial investigating the use of Pivlaz (clazosentan) failed to reach the primary endpoint in patients who had experienced a type of stroke called aneurysmal subarachnoid hemorrhage, leaving the drug’s future in the U.S. and Europe uncertain.

Impact to innovation at center of US Supreme Court enablement case

In preparing for their showdown before the U.S. Supreme Court March 27 on what it takes to show enablement for broad genus claims, both Sanofi SA and Amgen Inc. are warning that the sky could fall on future innovation if the court accepts the other company’s position. While Amgen claims the Federal Circuit’s new full-scope enablement test “discourages breakthrough innovations by cutting off patent protection for the most significant inventions simply because they have too many useful applications,” Sanofi said in its final brief, filed Friday, that the “true threat to innovation comes from allowing companies to monopolize an entire functional genus that they have not enabled.” Depending on how the Supreme Court rules, the impact of the case could reach beyond biopharma to med tech and other industries.

US GAO says HHS lacks funding for pandemic response preparedness plan

The U.S. Government Accountability Office has sounded off again about the ability of other federal government agencies to respond to future crises and pandemics, arguing that the Department of Health and Human Services has not forged a comprehensive assessment mechanism to account for the associated medical countermeasure production needs. However, GAO also remarked that HHS does not have a dedicated funding mechanism to finance these activities, a resource that might not become available until after HHS officials draft a budget for the activities associated with such efforts for congressional review.

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