Finch grabs a $53M round de­signed to take their ‘break­through’ mi­cro­bio­me treat­ment through a po­ten­tial­ly piv­otal tri­al

With a break­through des­ig­na­tion in one hand and a fresh $53 mil­lion in ven­ture back­ing in the oth­er, Somerville, MA-based Finch Ther­a­peu­tics is tak­ing a shot at a one-tri­al path­way to a pos­si­ble FDA OK for their new treat­ment for pre­vent­ing re­cur­rent C. dif­fi­cile in­fec­tions.

The fund­ing brings their to­tal raise for the mi­cro­bio­me com­pa­ny to $130 mil­lion, CEO Mark Smith tells me — enough mon­ey to pave a run­way past the FDA ap­proval they’ve sketched in­to the most op­ti­mistic ver­sion for their near-term fu­ture. 

Smith says that based on their talks with reg­u­la­tors, the FDA would be sat­is­fied if they could see high ef­fi­ca­cy in this tri­al. If the p val­ue comes in low­er, it would serve as the first of two, with reg­u­la­tors look­ing for con­fir­ma­tion of the ef­fect in a fol­low-up study.

Based on ear­li­er re­sults, Smith says a win­ning com­par­i­son would be around 80% ef­fi­ca­cy in the treat­ment arm com­pared to a con­trol arm ef­fect — where pa­tients just get an­tibi­otics — in the 40% to 50% mark.

“We were re­al­ly pleased with the out­come of the con­ver­sa­tion,” says the CEO.  “It’s a high bar for the ef­fect size we’re look­ing for.”

It’s no sure thing. Finch — who struck a deal to col­lab­o­rate with Take­da on IBD — is work­ing with da­ta they gath­ered in a small study, where they saw an 88% rate of ef­fi­ca­cy. Ef­fi­ca­cy was de­fined as two months with no re­cur­rence of the C. diff. That per­suad­ed them to see if they could blaze a path for­ward with a sin­gle piv­otal study, which would take them past a num­ber of ri­vals al­so fo­cused on the same tar­get.

That ef­fect, though, is “right in line” with fe­cal trans­plan­ta­tion. So why not con­tin­ue with the fe­cal ma­te­r­i­al?

In part be­cause it in­volves a pro­ce­dure, Smith replies, which a ther­a­py would cut out of the equa­tion. Sec­ond, if they can land an FDA ap­proval, reg­u­la­tors will like­ly re­quire the ap­proved ther­a­py over fe­cal trans­plan­ta­tion, which is still ex­per­i­men­tal. In ad­di­tion, the FDA is wary about fe­cal trans­plan­ta­tion, re­cent­ly not­ing a death due to an in­fec­tion from a mul­ti-drug re­sis­tant or­gan­ism picked up in one pro­ce­dure. 

Smith has some in­sights in­to the fe­cal trans­plan­ta­tion world gar­nered from a front-row seat. He’s been build­ing Finch Ther­a­peu­tics on the foun­da­tion pro­vid­ed by Open­Bio­me, a fe­cal trans­plant com­pa­ny he found­ed. And he’s been en­gi­neer­ing new prod­ucts based on that ex­pe­ri­ence with the gut.

And they’ve been mov­ing fast, pick­ing up their lead drug CP101 in a merg­er with Cresto­vo — which brought in ad­di­tion­al sup­port from Chris Shumway of Shumway Cap­i­tal — ex­e­cut­ing a $36 mil­lion C round a lit­tle more than a year ago.

Their time­line takes them to a tri­al read­out in H1 2020.

Suc­cess here would al­so ac­cel­er­ate their work on autism, which fol­lows up on some ev­i­dence that fe­cal trans­plan­ta­tion has an ef­fect here as well.

New in­vestors in­clud­ing OCV Part­ners, Susque­han­na In­ter­na­tion­al Group and Trans-Pa­cif­ic Tech­nol­o­gy Fund jumped in to the syn­di­cate, along­side ex­ist­ing in­vestors Avenir Growth Cap­i­tal, Mor­gan No­ble, Shumway Cap­i­tal, and Wil­lett Ad­vi­sors.

Con­quer­ing a silent killer: HDV and Eiger Bio­Phar­ma­ceu­ti­cals

Hepatitis delta, also known as hepatitis D, is a liver infection caused by the hepatitis delta virus (HDV) that results in the most severe form of human viral hepatitis for which there is no approved therapy.

HDV is a single-stranded, circular RNA virus that requires the envelope protein (HBsAg) of the hepatitis B virus (HBV) for its own assembly. As a result, hepatitis delta virus (HDV) infection occurs only as a co-infection in individuals infected with HBV. However, HDV/HBV co-infections lead to more serious liver disease than HBV infection alone. HDV is associated with faster progression to liver fibrosis (progressing to cirrhosis in about 80% of individuals in 5-10 years), increased risk of liver cancer, and early decompensated cirrhosis and liver failure.
HDV is the most severe form of viral hepatitis with no approved treatment.
Approved nucleos(t)ide treatments for HBV only suppress HBV DNA, do not appreciably impact HBsAg and have no impact on HDV. Investigational agents in development for HBV target multiple new mechanisms. Aspirations are high, but a functional cure for HBV has not been achieved nor is one anticipated in the forseeable future. Without clearance of HBsAg, anti-HBV investigational treatments are not expected to impact the deadly course of HDV infection anytime soon.

No­var­tis is ax­ing 150 ear­ly dis­cov­ery jobs as CNI­BR shifts fo­cus to the de­vel­op­ment side of R&D

Novartis is axing some 150 early discover jobs in Shanghai as it swells its staff on the drug development side of the equation in China. And the company is concurrently beefing up its investment in China’s fast-growing biotech sector with a plan to add to its investments in local VCs.

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Left to right: Arthur Pappas, Robert Nelsen, Peter Kolchinsky Doug Cole and David Beier

In rare po­lit­i­cal for­ay, top biotech in­vestors urge con­gress to re­ject drug pric­ing bill

Thirteen of the top biotech venture capitalists in the country wrote a letter last week warning lawmakers that if Congress passes a drug pricing bill House Speaker Nancy Pelosi has put before lawmakers, they won’t be able to invest in biomedical research at their current rate, and patients will suffer.

“If policies such as those included within H.R. 3, the Lower Drug Costs Now Act, are passed, our ability to continue to invest in future biomedical innovation will be severely constrained, thus crushing the hopes of millions of patient waiting for the next breakthroughs to treat or cure their cancers, rare genetic diseases, Alzheimer’s, or other serious and life-threatening conditions,” they wrote in a letter addressed to the highest-ranking Democrats and Republicans in the House and Senate and acquired by Endpoints News. 

Mer­ck’s $1B cash gam­ble pays off with a sur­pris­ing PhI­II car­dio suc­cess for Bay­er’s heart drug veri­ciguat

More than 3 years after Merck stepped up and paid $1 billion in cold, hard cash to gain the US commercial rights to Bayer’s high-risk heart drug vericiguat in a broad-ranging cardio alliance, the partners say their Phase III study has come through with promising data and a date with regulators.
We don’t have the data, and won’t until they put it out at an upcoming scientific session, but Merck touted the results, saying that their big Phase III VICTORIA study hit the primary endpoint  — with vericiguat combined with available therapies reducing “the risk of the composite endpoint of heart failure hospitalization or cardiovascular death in patients with worsening chronic heart failure with reduced ejection fraction (HFrEF) compared to placebo when given in combination with available heart failure therapies.”
Depending on the hard data, and how it breaks out with the combinations used, this drug could pose a threat to Novartis’ blockbuster drug Entresto, currently at $1.6 billion while analysts expect peak sales to hit $4 billion.
The drug is a soluble guanylate cyclase (sGC) stimulator, which Bayer and Merck have had high hopes for. Evidently, so did cardiologists. Cowen’s last analysis set potential sales at $400 million in 2024, but that number could go up significantly now.
Cowen’s Steve Scala noted this morning:
Vericiguat could be a lucrative product for Merck, and one with potentially under-appreciated value. At Cowen’s Therapeutics Conference in September 2019, 80% of specialists anticipated a positive result from VICTORIA whereas only 51% of investors shared this optimism.
Investigators recruited more than 5,000 patients at more than 600 centers in 42 countries for this study — one of the most expensive propositions in R&D. Millions of people in the US suffer from heart failure with reduced ejection fraction when the failing heart fails to contract properly to eject blood into the system. Bayer holds ex-US rights to the drug and also stands to earn cash from the $1.1 billion in milestones Merck agreed on for their collaboration.
Remarkably, the drug was pushed into Phase III despite failing the mid-stage trial — though investigators flagged a success at the high dose of 10 mg. In VICTORIA, researchers started patients at 2.5 mg and then titrated up to 5 and then 10 mg.

Alk­er­mes forges $950M biotech buy­out deal in a bold bet on an ear­ly-stage CNS drug plat­form

Alkermes $ALKS is investing $100 million cash and committing up to $850 million more in milestones in a big wager on a very early-stage CNS discovery platform. And the biotech is adding $20 million more to fund next year’s new research work on the platform it’s acquiring in today’s buyout with an eye to expanding the research work in oncology.

The biotech, helmed by Richard Pops, is buying Rodin Therapeutics, which had focused early on Alzheimer’s disease. Pops’ buyout, though, isn’t focused solely on the most troublesome sector in pharma R&D.

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Dicer­na scores broad, 'rest of liv­er' deal with No­vo Nordisk, bag­ging $225M in cash to hit some 30 tar­gets with RNAi plat­form

Turns out Dicerna wasn’t done with deals yet after locking in $200 million upfront from Roche for a hepatitis B cocktail two weeks ago.

Novo Nordisk has signed on as the latest partner to its GalXC RNAi platform, handing over $175 million in cash to claim any and all targets of interest in liver-related cardio-metabolic diseases that are not already reserved in previous pacts. The Danish drugmaker — which has signaled its interest to expand considerably beyond its core diabetes franchise into areas like NASH — is also purchasing $50 million worth of Dicerna’s equity at a 25% premium of $21.93 per share. More research payments and milestones extending to the billions are on the line.

Gene ther­a­py wins the in­side track at EMA; PPD files for IPO

→ Gene therapy maker Orchard Therapeutics has been granted an accelerated assessment for OTL-200 by the EMA’s Committee for Medicinal Products for Human Use (CHMP). The gene therapy — in development in partnership with the San Raffaele-Telethon Institute for Gene Therapy (SR-Tiget) in Milan, Italy — being used towards the treatment of metachromatic leukodystrophy.

→ Pharmaceutical Product Development has announced that its parent company, PPD, Inc has submitted a draft to the SEC relating to the proposal of an IPO of the parent company’s common stock. Number of shares and price range have not yet been determined.

Pfiz­er gets biosim­i­lar ap­proved for Hu­mi­ra, set­ting up com­pe­ti­tion — in 2023

In the story lawmakers and drug pricing reform advocates have told about the drug industry, there are perhaps few greater villains than Humira and its maker AbbVie.

Between 2012 and 2018, AbbVie upped the drug’s annual after-rebates cost from $19,000 to $38,000 in the US, with sticker prices now over $60,000 per year — increases that led to accusations of price gouging, most recently from Democratic presidential frontrunner Elizabeth Warren.

Eye­ing one of the first RNAi ther­a­pies and cho­les­terol block­buster, Med­Co shows de­tailed in­clisir­an da­ta

The main question was not whether it would work; it was if it would be safe.

The Medicines Company is out with new data on its LDL cholesterol drug inclisiran, and they confirm the first, tentative answers: Yes. They also keep MedCo on track for an imminent  FDA submission for one of the first RNAi therapies and a drug that could flip the cholesterol market. An EU application will follow in the first quarter of 2020.