BI-1820237

The amylin field is heating up ahead of Novo Nordisk’s much-anticipated CagriSema readout later this year. On Wednesday, Gubra said people taking high doses of its amylin analog, called GUBamy, had a mean loss of 3% of their body weight in a six-week single ascending dose trial. The placebo group, meanwhile, experienced a mean gain of about 1% body weight, the Danish biotech said. Men who were “healthy lean and overweight” were included in the trial. Nausea and reduced appetite were frequent, and vomiting was “occasional” in the trial, Gubra said. Gastrointestinal side effects have been commonly reported with anti-obesity medicines. The news comes the same day obesity biotech Metsera raised $215 million and said it had started testing its own amylin analog in an early-stage clinical study. “I’m excited about these data. It’s confirming what we hoped for that GUBamy is well-tolerated and we were able to dose to quite high levels, and we saw some dose dependency in adverse events,” which is “exactly what you would expect from an amylin,” Gubra CEO Henrik Blou said in an interview with Endpoints News . Gubra’s shares were up about 2%. The company said it plans to share interim results from a multiple ascending dose study in the first half of next year. The biotech believes GUBamy, or GUB014295, can be dosed weekly given its 11 day half-life. Blou declined to disclose Gubra’s expectations for weight loss in the MAD Phase 1b trial. Zealand Pharma’s amylin analog petrelintide led to a mean 8.6% weight loss in a MAD study in June , and the company quickly raised $1 billion off that data. Asked if Gubra also plans to raise money or do a follow-on offering on the back of these data, Blou said Gubra has “no current plans” since the company is “currently well-financed.” Gubra can take GUBamy into Phase 2a, the CEO said, but the company is also exploring partnerships. It counts Boehringer Ingelheim as a partner on other obesity programs. There are likely multiple parties circling the company as amylin has come to the fore as a next-generation approach in the obesity drug landscape. Amylin and other approaches follow the first-generation GLP-1 medicines, which have opened up what is expected to be the biggest pharmaceutical market in history. Novo’s CagriSema, which combines an amylin analog with Wegovy, is slated to have a Phase 3 readout before 2025. Zealand, meanwhile, boasted at the ObesityWeek conference that it believes amylin could potentially replace GLP-1s for some patients. Eli Lilly, AstraZeneca, Structure Therapeutics and others are also in the race. GUBamy is one of multiple shots on goal for Gubra’s obesity pipeline. Its partner Boehringer started testing a triple agonist, of unknown mechanisms, in a Phase 1 this summer. However, Boehringer ended work on a different Gubra obesity drug last month. The duo is also working on other discovery-stage programs, and Gubra is working on its own with other targets, like UCN2 and GLP-1. Blou said Gubra is “still gathering information” on the culled Boehringer drug, a neuropeptide Y receptor type 2 (NPY2) agonist known as BI 1820237. Once it gets the “full picture,” they’ll have a better idea of the drug’s future, he added.

Plus, news about Alnylam, Hutchmed, Wave Life Sciences and Matinas BioPharma: Boehringer Ingelheim ends work with Gubra on obesity drug: The German drugmaker stopped developing Gubra’s long-acting neuropeptide Y receptor type 2 (NPY2) agonist known as BI 1820237 . The pact , which started in 2017, could have led to about $262 million in milestones for Gubra, the company previously said. The termination doesn’t impact the duo’s three other programs, including a triple agonist for obesity that started a Phase 1 trial this summer. — Kyle LaHucik Galapagos resumes CAR-T trial: The Belgian drugmaker resumed enrollment in a Phase 1/2 study testing a BCMA CAR-T for certain multiple myeloma patients. The biotech had paused the study of GLPG5301 in August after a Parkinsonism event was seen in one patient. In its quarterly update, Galapagos also said it is looking for more external partners by way of research pacts, licensing deals or potential bolt-on acquisitions. — Kyle LaHucik Alnylam culls diabetes asset: The drugmaker stopped development of an RNAi therapy in Phase 1/2 for type 2 diabetes mellitus. The biotech attributed the termination to “portfolio prioritization efforts.” — Kyle LaHucik Hutchmed records $20M milestone: The payment from Takeda occurred after colorectal cancer treatment Fruzaqla generated $200 million in sales. The drug was approved by the FDA last year. — Jaimy Lee Wave Life Sciences said preclinical obesity data support improved durability: A single dose of Wave’s siRNA obesity treatment spurred “sustained change in body weight up to 12 weeks” in a mouse model. The data, presented Wednesday at Wave’s research day , suggest the potential for dosing only one or two times per year, according to the company. It also found that there was roughly two times greater weight loss when its siRNA was added onto a GLP-1 drug. — Max Bayer Matinas BioPharma lays off 15 workers: The New Jersey biotech ended negotiations for its oral formulation of amphotericin B and let go its chief medical officer, business chief and technology chief. It had 32 employees , as of March 18. Its stock $MTNB tumbled 65% on Thursday morning. — Kyle LaHucik