Protagonist propels forward in ulcerative colitis.
Inovio looks to a consortium for help fighting anal precancer.
BioCryst lands Fast Track for their late-stage vascular drug.
Welcome to another edition of "3 Things In Biotech You Should Learn Today," a daily digest dedicated to helping you keep pace with the fast-moving world of pharmaceutical and biotechnology research.
Protagonist propels forward in ulcerative colitis
Company: Protagonist Therapeutics (PTGX)
Disease: Ulcerative colitis
News: PTGX announced findings from their phase 2 PROPEL study investigating their a5b7-integrin antagonist PTG-100 for use in patients who have ulcerative colitis. Blinded analysis of the reading from the endoscopies demonstrated that the trial was suspended based on premature readouts, and there appears to be a signal of efficacy for this agent after all. For context, the CRO that PTGX originally contracted out to do this data analysis originally found a higher-than-expected effect from the placebo, leading to futility for the trial and suspension of the program.
Looking forward: This is a highly unusual surprise, as you don't often see these studies get their results re-assessed in this way, and you really don't see the findings get reversed. Now, PTGX feels that they have enough evidence to warrant continued clinical investigation with PTG-100, which would be a big opportunity for the company, given that their drug is an oral medication in a field dominated by intravenous agents.
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Inovio looks to a consortium for help fighting anal precancer
Company: Inovio Pharmaceuticals (INO)
Disease: Anal dysplasia
News: INO announced that they have begun a partnership with the AIDS Malignancy Consortium to investigate their anti-HPV DNA vaccine VGX-3100 in patients with HPV-associated anal dysplasia in HIV-positive women. The collaboration will feature the conduct of an open-label phase 2 study seeking to enroll 75 patients, who will receive four doses of the drug.
Looking forward: The slow march of progress continues, as INO pushes their electroporation-delivered DNA vaccines into the clinic. This particular collaboration could help net faster recruitment and some cost savings for INO, although we do not know what financial terms may have been reached. It's not the biggest news for the company, but it could be the start of addressing an important unmet need.
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BioCryst lands Fast Track for their late-stage vascular drug
Company: BioCryst (BCRX)
Disease: Hereditary angioedema
News: BCRX announced that the FDA has granted their plasma kallikrein inhibitor BCX3753 Fast Track designation for the prevention of angioedema attacks in patients with hereditary angioedema. This designation was based on positive findings from a few early-stage trials, and it unlocks some key perks for the company as they move forward in the regulatory channels.
Looking forward: Fast Track is always a sort of mixed bag designation for me. It doesn't mean an approval is imminent by any stretch, and often drug programs take several more years once they get Fast Track. However, once the data are in, this can be important, as it opens up Accelerated Approval and other bonuses that can shorten the time to market. For a long-term proposition, Fast Track is nothing but a blessing for BCRX.
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