Im­age: Colleen Cut­cliffe WHOLE BIO­ME

The boom in mi­cro­bio­me ther­a­peu­tics has el­e­vat­ed the “good” gut bac­te­ria from pro­bi­otics to drug sta­tus, spurring some up­starts backed by promi­nent ven­ture in­vestors to take their ther­a­pies on the high­ly reg­u­lat­ed jour­ney to­ward an FDA ap­proval. But Whole Bio­me wants to go a sep­a­rate di­rec­tion by oc­cu­py­ing the mid­dle ground with what it’s call­ing “med­ical pro­bi­otics.”

“This is ba­si­cal­ly a prod­uct that has phar­ma­ceu­ti­cal grade ef­fi­ca­cy, clin­i­cal ef­fi­ca­cy, but it has es­sen­tial­ly got the safe­ty of a pro­bi­ot­ic,” CEO Colleen Cut­cliffe tells me as the com­pa­ny emerges from stealth mode with $35 mil­lion in Se­ries B cash.

Jim Bullard Whole Bio­me

Cut­cliffe, a vet­er­an of Elan Phar­ma­ceu­ti­cals, was work­ing at the DNA se­quenc­ing com­pa­ny Pa­cif­ic Bio­sciences when she met her co-founders, Jim Bullard and John Eid. Com­bin­ing their bio­chem­istry, bio­sta­tis­tics and physics back­ground, the trio built a plat­form that com­pares deep se­quenc­ing da­ta from dif­fer­ent pop­u­la­tions, ar­riv­ing at meta­bol­ic maps that sug­gest ex­act­ly which mi­crobes are miss­ing in pa­tients with cer­tain dis­eases.

Se­quoia Cap­i­tal was an ear­ly sup­port­er of the 6-year-old ven­ture, chip­ping in­to the cur­rent round with True Ven­tures, Khosla Ven­tures, Mayo Foun­da­tion, AME Cloud Ven­tures and oth­ers. Roelof Botha is join­ing the board.

John Eid Whole Bio­me

Whole Bio­me plans to com­mer­cial­ize its first off-the-shelf prod­uct, for type 2 di­a­betes, ear­ly next year. Da­ta from sev­er­al re­cent — though un­pub­lished — place­bo-con­trolled clin­i­cal tri­als show that their treat­ment achieved re­duc­tion in A1C and glu­cose spikes on top of the stan­dard met­formin reg­i­men, Cut­cliffe says.

The the­o­ry is that peo­ple with type 2 di­a­betes lack the mi­crobes that are en­tire­ly re­spon­si­ble for me­tab­o­liz­ing fiber, which then trig­gers GLP1 re­sponse for reg­u­lat­ing glu­cose and in­sulin. WBF-011, which Whole Bio­me in­tends to mar­ket as a med­ical food, is de­signed to put ex­act­ly those mi­crobes back.

With 40 staffers and its own man­u­fac­tur­ing op­er­a­tions at its San Fran­cis­co base, the com­pa­ny is al­so ex­plor­ing oth­er prod­ucts for ir­ri­ta­ble bow­el syn­drome and a third, undis­closed in­di­ca­tion.

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.