Klein­er Perkins-backed El­celyx says its re­for­mu­lat­ed met­formin worked in a PhI­Ib di­a­betes study

El­celyx CEO Alain Baron

A lit­tle over a year ago San Diego-based El­celyx Ther­a­peu­tics raised a $40 mil­lion E round to prove in a Phase IIb study that it had found a way to treat a large seg­ment of di­a­bet­ics who can’t be helped by or tol­er­ate the stan­dard treat­ment met­formin.

This morn­ing, the biotech said the gam­ble — with the mon­ey com­ing from a mix of Chi­nese and US in­vestors, in­clud­ing Klein­er Perkins — paid off with pos­i­tive da­ta.

Met­formin DR is tar­get­ed at the low­er small in­tes­tine so that it can be used to treat pa­tients with re­nal im­pair­ment or who can’t tol­er­ate the cur­rent met­formin for­mu­la­tions. And in the study the drug arm achieved sta­tis­ti­cal­ly sig­nif­i­cant re­duc­tions of HbA1c at 16 weeks, El­celyx says, though the com­pa­ny didn’t spell out the da­ta.

Di­a­betes is a big field, but one that is on­ly rarely tack­led by the biotech crowd, which can find it hard to get the fi­nan­cial back­ing need­ed to see projects through Phase III. El­celyx says it now knows what dos­es of re­for­mu­lat­ed Met­formin to take in­to Phase III, but it didn’t say ex­act­ly how it plans to pay for the kind of large late-stage pro­gram that reg­u­la­tors in­sist on.

There were al­so a few caveats to note on the com­pa­ny’s state­ment:

The glycemic ef­fect of Met­formin DR was some­what less than that seen with a max­i­mal­ly ef­fec­tive dose of met­formin im­me­di­ate re­lease (IR), but with sig­nif­i­cant­ly and dis­pro­por­tion­al­ly low­er sys­temic ex­po­sure. The sub­group of sub­jects who com­plet­ed the study and ad­hered to all pro­to­col re­quire­ments showed a pat­tern of glycemic im­prove­ment com­pa­ra­ble to that seen with the over­all study pop­u­la­tion.

Three years ago, when the com­pa­ny broke stealth cov­er, CEO Alain Baron told me that the com­pa­ny had big plans for NewMet, along with a di­etary sup­ple­ment in de­vel­op­ment that was lat­er sold off. Baron is a for­mer se­nior VP of re­search at Amylin, which was bought out by Bris­tol-My­ers Squibb $BMY. Its $40 mil­lion round was led by the Hong Kong-based pri­vate eq­ui­ty in­vestor Sail­ing Cap­i­tal.

“Pa­tients with type 2 di­a­betes whose ad­vanced kid­ney dis­ease pre­vents them from ef­fec­tive­ly clear­ing met­formin from their cir­cu­la­tion are at in­creased risk for po­ten­tial­ly tox­ic met­formin-as­so­ci­at­ed lac­tic aci­do­sis,” said Robert Hen­ry, MD, pro­fes­sor of med­i­cine at the UC San Diego School of Med­i­cine. “Gut-me­di­at­ed Met­formin DR which has min­i­mal ab­sorp­tion lead­ing to low­er sys­temic ex­po­sure with clin­i­cal­ly rel­e­vant glu­cose low­er­ing ef­fects is an es­pe­cial­ly at­trac­tive propo­si­tion for the treat­ment of type 2 di­a­betes pa­tients with re­nal im­pair­ment, as well as for pa­tients un­able to take full dos­es of met­formin due to gas­troin­testi­nal side ef­fects.”

In­side Track: Be­hind the Scenes of a Ma­jor Biotech SPAC

Dr. David Hung and Michelle Doig are no strangers to the SPAC phenomenon. As Founder and CEO of Nuvation Bio, a biotech company tackling some of the greatest unmet needs in oncology, Dr. Hung recently took the company public in one of this year’s biggest SPAC related deals. And as Partner at Omega Funds, Doig not only led and syndicated Nuvation Bio’s Series A, but is now also President of the newly formed, Omega-sponsored, Omega Alpha SPAC (Nasdaq: OMEG; oversubscribed $138m IPO priced January 6, 2021).

Hal Barron, GSK R&D chief (Endpoints News)

Hal Bar­ron gam­bles $625M cash on high-wire TIG­IT act, throw­ing Glax­o­SmithK­line in­to heat­ed race and com­plet­ing next-gen I/O trin­i­ty

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The stakes are as high as the risks: While a growing pack of Big Pharma rivals is lending credence to the hypothesis that TIGIT will be the next big immune checkpoint and cancer drug target, the first clinical trials have shown response rates that can be described as modest at best. But Barron’s bet is on the whole “axis” that the receptor sits on, with an eye on testing its new anti-TIGIT antibody not just in combo with PD-1 but also in triplets.

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As Covid-19 shifts the world's at­ten­tion to biotech, Noubar Afeyan's Flag­ship builds $3.4B fund to fu­el new in­ven­tions. Here's the plan

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Bio­gen sig­nals a big PhI­II fail­ure as the lead gene ther­a­py in their $800M Night­star buy­out goes down in flames

That $800 million buyout of Nightstar has turned into a bust for Biogen as the lead therapy in the deal failed a pivotal study, signaling a severe setback for the biotech’s ambitions in gene therapies.

The big biotech put out the word after the market closed on Monday that the gene therapy they picked up in the deal for a degenerative blindness called choroideremia failed the Phase III study, just a month after their #2 drug in the deal also flopped in a mid-stage study.

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Geoffrey Porges, SVB Leerink

Top an­a­lyst maps a rocky road for Ver­tex — un­less they adopt a $10B M&A cam­paign to save the pipeline

After repeatedly poking Vertex $VRTX execs with pointed criticism of their R&D strategy, top SVB Leerink analyst Geoffrey Porges is now turning up the heat to a full-scale roasting.

In a note out early Monday morning, Porges spotlights the impact of Vertex’s recent follow-up failure on AATD — their treatment hit the endpoint but missed on commercial prospects — rewriting his recommended scenario for CEO Reshma Kewalramani as she grapples with the setback.

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Stephen Hahn (AP Images)

UP­DAT­ED: Ex-FDA com­mish Stephen Hahn joins Flag­ship, a ven­ture group that spawned Covid-19 vac­cine mak­er Mod­er­na

That revolving door between the FDA and industry is spinning even faster than usual.

Former FDA commissioner Stephen Hahn is joining Flagship Pioneering, the venture outfit that founded Moderna — which raced its way to an FDA EUA for a Covid-19 vaccine that is making billions of dollars– as the new CMO of its Preemptive Medicine and Health Security initiative.

Flagship confirmed the hire — first reported in The Washington Post — in a statement out late Monday.

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Patrizia Cavazzoni, CDER

FDA’s Cavaz­zoni calls for ad­comms to ‘get back to the sub­stance’

While her comments were recorded prior to the FDA’s recent approval of Biogen’s controversial Alzheimer’s drug, CDER Director Patrizia Cavazzoni presciently called for substantiating reforms to the advisory committee process at the agency.

Short on examples, Cavazzoni said at a BIO event aired on Monday that some recent adcomms show “how they can be swayed by emotion in the face of hard facts,” but they need to “get back to the fundamentals, which is listening to thoughtful input from experts in response to thoughtful questions that we ask them.”

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Terns Phar­ma­ceu­ti­cals touts safe­ty da­ta from an ex-Eli Lil­ly can­di­date in the hunt for NASH treat­ment

While many others have tried — and failed — to get a NASH candidate across the finish line, Terns Pharmaceuticals thinks its FXR agonist will eventually earn its wings without the safety issues that have slowed others down. Now, a mid-stage safety readout could help add some validity to those hopes.

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Paul Burton, incoming Moderna CMO (J&J/file photo)

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Moderna is turning to one of its Covid-19 vaccine competitors to fill its open CMO slot, but this time, it’s not the vaccine experience they’re after.

Paul Burton, who’s spent 16 years at J&J, most recently as chief global medical affairs officer of Janssen, will take over as Moderna CMO on July 6.

With an eye toward a future beyond the pandemic, the mRNA biotech went with Burton, who earned his MD and PhD degrees in London, as he offers experience on a range of therapeutic areas, as well as work as a cardiothoracic surgeon and leading tech projects with Apple.

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