AG-011

Applied Molecular Transport’s lead program hit a roadblock Wednesday with a mid-stage flop in ulcerative colitis, failing to perform better than Humira. When tested in combination with the longstanding multi-billion dollar drug powerhouse at AbbVie, AMT’s drug was worse at clinical remission rates compared to Humira alone (alongside placebo) in treating patients with inflammatory bowel disease. Of the 22 patients who were in the AMT-101 plus Humira combo arm, seven experienced clinical remission, compared to nine of 27 patients in the placebo plus Humira cohort. In percentages, that’s 31.8% versus 33.3% in the eight-week study in four European countries. Another two patients had been randomized into the study in Ukraine but were not included in efficacy analyses because of the Russian invasion. The Phase II MARKET trial results sent AMT’s shares $AMTI tanking by nearly 30% after the opening bell Wednesday. Jefferies analyst Chris Howerton has pinned the drug’s potential sales in the multi-billion dollar range, but green lights are likely years away. “We did not anticipate the high rates of remission in the adalimumab alone arm,” CMO Bittoo Kanwar said on an investor call. Like most biotechs that don’t pass muster in mid-and late-stage studies, AMT took a deep dive into the data and tried picking out specific points that could shine a positive light on the drug. In that vein, AMT said earlier treatment might be beneficial for patients. Among patients who’ve had UC for less than five years, those on combo treatment showed a clinical remission rate of 43.8% versus 15.4% in the Humira mono arm. With that in mind, the company will engage with the FDA on the next steps, Kanwar said in the investor presentation. The company is currently prioritizing an end-of-Phase II meeting in chronic pouchitis first, to occur later this summer, and hopes to “shortly thereafter” meet with the agency on a “potential path forward in combination therapy” in UC, Kanwar said. “Our strategy would be, let’s provide combination therapy earlier so that we can have a greater proportion of patients in remission earlier in their disease before long-term damage occurs in the intestine,” the CMO said on the investor call. The patients in the MARKET trial might not be totally representative of the type of patients AMT would expect to treat in the US and other Western nations, Kanwar described on the investor call, noting many patients in the US and Western Europe are treated earlier during the course of UC. With the trial mainly in Eastern Europe (Georgia, Netherlands, Poland and Ukraine), where patients had a longer duration of UC progression “upwards of eight years,” Kanwar said, “those patients don’t really exist in the Western world and/or developed nations.” The drug was “safe and well-tolerated,” the biotech said, noting the one serious treatment-emergent adverse event, a worsening of UC, was determined to be unrelated to the drug. AMT-101 — a once-daily, oral fusion of IL-10 and a proprietary carrier molecule — is at the center of the biotech’s refocused ambitions. The drug aims to cross the intestinal epithelial barrier while avoiding the bloodstream. AMT has pinned its hopes on inflammatory bowel and systemic inflammatory conditions. The MARKET study is one of multiple in UC, with another Phase II — as a monotherapy — expected to read out before year’s end. The biotech also has upcoming discussions with the FDA on a Phase III development program in chronic pouchitis, which is inflammation of the pouch that is given to patients after surgery to remove the colon or large intestine. A mid-stage trial in that condition proved successful in April.

Nov. 9, 2021 13:00 UTC NEW YORK--(BUSINESS WIRE)-- Xalud Therapeutics, a clinical-stage biotechnology company developing non-viral gene therapies to treat pathologic inflammation through immune modulation, today announced the appointment of Charles Triano as its chief financial officer. Mr. Triano brings nearly 35 years of industry experience with deep ties in the global investment community. “Chuck brings a strong reputation with an invaluable skillset and perspective to the Xalud leadership team given his broad experience in corporate finance, investor relations and communications,” said Diem Nguyen, Ph.D., chief executive officer of Xalud. “With his proven track record of success over the last three decades at Pfizer, I look forward to seeing Chuck support Xalud’s bold mission of developing a non-viral gene therapy platform for millions of patients.” Mr. Triano joins Xalud from Pfizer, where he served as senior vice president of investor relations since 2008. Throughout Chuck’s tenure at Pfizer, he worked closely with the company’s executive leadership team as Pfizer transformed itself to a pure science-focused BioPharmaceutical company and saw its market value nearly double to over $230 billion during this time. He was responsible for all global investor relations activities, as well as operations planning and analysis functions. Following his appointment as head of investor relations, Pfizer’s investor relations program became consistently ranked as a top program in the pharmaceutical sector, and Mr. Triano was consistently named as a top investor relations officer in the sector according to Institutional Investor Magazine’s “Best of Corporate America” survey of institutional portfolio managers and analysts. Prior to his time at Pfizer, Mr. Triano served as the vice president of investor relations of Forest Laboratories, where he initiated the company’s first formal investor relations and corporate communications program. “I’m excited to join Xalud as it achieves key clinical milestones, including top line efficacy results for its phase 2b osteoarthritis of the knee trial soon and last patient final study visit by mid-2022,” said Mr. Triano. “I look forward to contributing to Xalud’s tremendous growth potential with the development of medicines to help alleviate the high disease burden and unmet medical need across a broad range of chronic inflammatory diseases.” About Xalud Therapeutics Xalud Therapeutics is a biotechnology company developing a non-viral gene therapy platform to treat pathologic inflammation through immune modulation. The company is harnessing the power of interleukin-10 (IL-10), a potent cytokine that acts as a master regulator for multiple inflammatory pathways, to address the root cause of inflammation and subsequently restore homeostasis in the immune system. Xalud’s lead product candidate, XT-150, is a locally injectable plasmid DNA gene therapy expressing IL-10v, a proprietary modified variant of IL-10, that addresses pathologic inflammation and pain.