Jay Luly, Enanta CEO (via YouTube)

Safe­ty threat forces Enan­ta to scrap HBV tri­als — send­ing dis­cov­ery team back to draw­ing board

A Mass­a­chu­setts biotech will dis­con­tin­ue the de­vel­op­ment of its oral drug in­tend­ed to treat pa­tients suf­fer­ing from chron­ic he­pati­tis B in­fec­tions, the com­pa­ny said Thurs­day.

Enan­ta Phar­ma­ceu­ti­cals will no longer de­vel­op EDP-721. The news comes af­ter safe­ty sig­nals were seen in healthy par­tic­i­pants in a Phase I tri­al af­ter they were ad­min­is­tered the drug, and de­spite a clean safe­ty pro­file demon­strat­ed in pre­clin­i­cal tri­als.

“Pa­tient safe­ty is our top pri­or­i­ty, and we have there­fore de­cid­ed to dis­con­tin­ue fur­ther de­vel­op­ment of this com­pound,” said CEO Jay Lu­ly. “We are com­mit­ted to de­vel­op­ing a func­tion­al cure for chron­ic he­pati­tis B pa­tients, and re­main con­fi­dent in EDP-514, our HBV core in­hibitor, which has demon­strat­ed safe and ro­bust an­tivi­ral ac­tiv­i­ty in Phase 1b stud­ies of viremic and NUC-sup­pressed pa­tients with chron­ic HBV in­fec­tion.”

Enan­ta will ad­vance its HBV pro­gram af­ter fur­ther dis­cov­ery ef­forts, Lu­ly said.

He­pati­tis B is a vi­ral in­fec­tion that can at­tack the liv­er and cause both acute and chron­ic dis­ease. It is most typ­i­cal­ly trans­mit­ted from moth­er to child in birth and de­liv­ery, as well as through oth­er bod­i­ly flu­ids. An es­ti­mat­ed 290 mil­lion peo­ple around the world have chron­ic HBV in­fec­tions.

Enan­ta is cur­rent­ly de­vel­op­ing can­di­dates to tar­get res­pi­ra­to­ry syn­cy­tial virus, HBV and Covid-19. Its R&D ef­forts are fund­ed through roy­al­ties from its he­pati­tis C virus prod­ucts de­vel­oped along­side Ab­b­Vie.

Ear­ly last month, the com­pa­ny of­floaded in-house de­vel­op­ment of its two FXR ag­o­nist NASH drugs, EDP-305 and fol­low-up can­di­date EDP-297, and said it would move to an out-li­cens­ing strat­e­gy af­ter the ear­ly da­ta showed lit­tle chance of so­lo suc­cess for ei­ther drug. Baird an­a­lyst Bri­an Sko­r­ney called the de­ci­sion “in­cre­men­tal­ly pos­i­tive,” re­mark­ing that Enan­ta could fo­cus its work on ef­forts in Covid-19, RSV and HBV, while avoid­ing the long, wind­ing road that comes along with NASH. But the lat­est set­back will send the com­pa­ny back to the draw­ing board again.

“We be­lieve that the mul­ti­ple mech­a­nisms in de­vel­op­ment for NASH to­day, which re­flect the com­plex patho­phys­i­ol­o­gy of this dis­ease, make it like­ly that a com­bi­na­tion ap­proach with FXR ag­o­nists will ul­ti­mate­ly pro­vide the op­ti­mal treat­ment reg­i­men for pa­tients,” Lu­ly said in a state­ment.

Enan­ta did an­nounce pos­i­tive da­ta from its Phase Ib study of EDP-514 to treat NUC-sup­pressed chron­ic HBV pa­tients. The tri­al showed that it was safe and well-tol­er­at­ed, and the da­ta sup­port a once-dai­ly oral dos­ing reg­i­men.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; and more

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Usama Malik

Ex-Im­munomedics CFO charged with in­sid­er trad­ing, faces up to 20 years in prison af­ter al­leged­ly tip­ping off girl­friend and rel­a­tives of a PhI­II suc­cess

The former CFO of Immunomedics, who helped steer the company to its $21 billion buyout by Gilead last year, has been charged with insider trading, the Department of Justice announced Thursday.

Usama Malik tipped off his then-girlfriend and four others that a Phase III study for Trodelvy would be stopped early four days before Immunomedics publicly announced the result in April 2020, DoJ alleged in its complaint. The individuals then purchased Immunomedics shares, selling them after the news broke and Immunomedics’ stock price doubled.

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Pfiz­er, Am­gen and Janssen seek fur­ther clar­i­ty on FDA's new ben­e­fit-risk guid­ance

Three top biopharma companies are seeking more details from the FDA on how the agency conducts its benefit-risk assessments for new drugs and biologics.

While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.

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Vas Narasimhan, Novartis CEO (Thibault Camus/Pool via AP Images)

With gener­ic com­pe­ti­tion heat­ing up, Vas Narasimhan out­lines No­var­tis' growth plans at R&D day

Thursday marks Novartis’ annual R&D day, and with it comes CEO Vas Narasimhan’s attempt to spotlight the company’s pipeline strategy and emerging stars.

The biggest question entering Thursday’s presentation dealt with how the big biopharma will make up revenues from upcoming generic competition — Novartis says within the next five years, generics will eat away roughly $9 billion in sales. To offset this, Narasimhan outlined a strategy for 4% growth or higher until 2026, focusing on six key medicines he believes will see multibillion dollar profits during this time.

In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

Reshma Kewalramani, Vertex CEO (Vertex via YouTube)

Bat­tling a line­up of skep­tics, Ver­tex claims an­oth­er ear­ly clin­i­cal win — this time in kid­ney dis­ease

Vertex claimed its second early-stage win of the fall Wednesday, announcing positive results in a small study on a genetically defined form of kidney disease.

The 16-patient, Phase II trial focused on patients with focal segmental glomerulosclerosis, a rare disease where kidneys are unable to filter blood properly. Over 13 weeks on an experimental pill, the level of protein in the patients’ urine fell by an average of 47.6%.

Ab­b­Vie tacks on a new warn­ing to Rin­voq la­bel as safe­ty frets crimp JAK class

The safety problems that continue to plague the JAK class as new data highlight some severe side effects are casting a large shadow over AbbVie’s Rinvoq.

As a result of a recent readout highlighting major adverse cardiac events (MACE), malignancy, mortality and thrombosis with Xeljanz a couple of months ago, AbbVie put out a notice late Friday afternoon that it is adding the new class risks to its label for their rival drug.

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