While sorting out a second phase III study design for its cancer therapy and light device with the U.S. FDA, Soligenix Inc. produced positive results from a compatibility study evaluating Hybryte (synthetic hypericin sodium) for treating early stage cutaneous T-cell lymphoma (CTCL). That data, according to Soligenix, bolster findings from the phase III FLASH study, which used the same combination in treating CTCL. According to Christopher Schaber, Soligenix CEO, the important corporate objectives for the compatibility study were to replicate results seen in the FLASH study.
In January, a Wall Street analyst predicted the U.S. FDA’s rejection of Eli Lilly and Co.’s application seeking accelerated approval of amyloid beta-targeting Alzheimer’s candidate, donanemab, would be a “mere footnote” in the drug’s development, a forecast confirmed in the wake of positive top-line phase III data showing donanemab significantly slowed cognitive and functional decline in people with early symptomatic disease.
Immunogen Inc. scored a major win in top-line data from the confirmatory phase III trial called Mirasol evaluating the approved antibody-drug conjugate Elahere (mirvetuximab soravtansine-gynx, “mirv”) vs. chemotherapy in patients with folate receptor alpha-positive platinum-resistant ovarian cancer (PROC). The victory led shares of the Waltham, Mass.-based firm to close May 3 at $12.26, a rise of $7.06, or 135%.
Saddled with disappointing results from a phase III trial with Filspari (sparsentan) in focal segmental glomerulosclerosis (FSGS), officials of Travere Therapeutics Inc. stressed the differences between that disorder and IgA nephropathy (IgAN) – for which the drug was cleared by the U.S. FDA in February. Two-year IgAN efficacy data are due in the fourth quarter of this year.
A precancerous condition caused by the human papillomavirus (HPV) affects up to 300,000 American women who are diagnosed each year, and yet there are no treatments, just preventive vaccines introduced in 2006 – targeted to younger generations prior to the first sexual encounter. That leaves a large proportion of the female population stuck with a “wait-and-see” approach that involves continuous monitoring of their HPV infection through pap smears to detect cellular changes that could lead to cervical cancer. South San Francisco-based Antiva Biosciences Inc. is seeking to find a better response to this condition known as high-grade cervical intraepithelial neoplasia (CIN2,3) with its lead topical therapeutic, ABI-2280, a prodrug of an acyclic nucleoside phosphonate that is currently in phase I trials.
Despite posting positive phase IIa data, Pliant Therapeutics Inc. stock (NASDAQ:PLRX) took a punch May 1 as shares closed 21% downward at $22.31 each. Still, the stock is in far better shape than it was a year ago when shares were going for about $5 each.
Touting what’s been so far the “cleanest safety profile that’s been presented with genetic medicine in the eye,” deemed “a game changer for this field,” 4D Molecular Therapeutics Inc. CEO David Kirn said phase III planning will begin in later this year to test gene therapy 4D-150 in wet age-related macular degeneration (AMD).
Positive phase III results from Surmount-2 of Eli Lilly and Co.’s Mounjaro (tirzepatide) showed overweight and obese type 2 diabetes patients receiving the highest dose lost up to 34.4 pounds, with the majority achieving at least a 5% decrease in overall body weight. The results will help the Indianapolis-based company complete its rolling supplemental NDA with the U.S. FDA targeting an approval for obese and overweight adults with weight-related co-morbidities.
The long-anticipated top-line phase IIa study results for Morphic Therapeutic Inc.’s oral alpha 4 beta 7 integrin inhibitor, MORF-057, have surpassed even the company’s own expectations, with a significant decline in disease activity seen in moderate to severe ulcerative colitis (UC) patients combined with a safety profile consistent with phase I findings.
The data are early and from only seven evaluable patients, but results from In8bio Inc.’s phase I study of gamma-delta T-cell therapy INB-100 in leukemia patients who have undergone haploidentical hematopoietic stem cell transplant, presented at the European Society for Blood and Marrow Transplantation meeting, were compelling enough to drive the company’s shares (NASDAQ:INAB) up 183% April 24.
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