ARTICLE | Product Development

Jan. 4 Quick Takes: Roivant TL1A mAb heading into Phase III in ulcerative colitis 

Plus: 16 years on, Geron forges ahead with imetelstat and updates from NextPoint, Moderna, Hummingbird-Synaffix and more   

January 5, 2023 12:35 AM UTC

A Phase III showdown between anti-TL1A mAbs for ulcerative colitis is shaping up for 2023 with positive Phase IIb data for RVT-3101 from Roivant Sciences Ltd. (NASDAQ:ROIV) announced less than a month after Prometheus Biosciences Inc. (NASDAQ:RXDX) reported Phase II results for PRA023. In the Phase IIb TUSCANY-2 study in 245 patients with moderate to severe ulcerative colitis, monthly administrations of Roivant’s RVT-3101 led to clinical remission in 32% of patients treated across three doses (p=0.01), while 40% achieved endoscopic improvement (p=0.01) after the 12-week induction period, with a comparable 31% clinical remission rate and 40% endoscopic improvement rate at the recommended Phase III dose. Among an undisclosed number of patients who were positive for a biomarker, 40% achieved clinical remission (p=0.02) and 56% achieved endoscopic improvement (p=0.0005). Roivant, whose shares rose $0.41 to $7.56 Wednesday, and Prometheus are each planning Phase III studies for the TL1A mAbs this year.

Sixteen years after imetelstat entered the clinic, Geron Corp. (NASDAQ:GERN) said it is expecting to submit regulatory applications later this year after the telomerase inhibitor met the primary endpoint of transfusion independence at eight weeks in the Phase II/III IMerge trial to treat low-risk patients with myelodysplastic syndrome (MDS). The news saw shares climb to a 52-week high and finished on Wednesday up $0.79 (33%) to $3.19, giving the biotech a market cap of about $1.2 billion. The long-storied biotech’s stock price had reached an all-time high of $71.42 per share during the 2000 genomics bubble, but hasn’t been above $20 since that year...