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Bel­lus hopes to fu­el up on IPO cash as it squares off with gi­ant Mer­ck on a ri­val drug

Fu­eled by a suc­cess­ful Phase I tri­al treat­ing chron­ic cough and lured by the promise of tak­ing their lead drug to oth­er ap­pli­ca­tions, Mon­tre­al-based Bel­lus Health is look­ing to make its de­but on Nas­daq with a $60 mil­lion IPO.

The pub­lic of­fer­ing could be a ma­jor boon to the small Cana­di­an com­pa­ny as it looks to out­pace phar­ma gi­ant Mer­ck in the race to bring a P2X3-block­ing drug to mar­ket. Block­ing the P2X3 re­cep­tor is a close­ly stud­ied method for re­duc­ing dis­or­ders around hy­per­sen­si­tiv­i­ty, in­clud­ing most promi­nent­ly chron­ic cough.

Mer­ck has al­ready brought their ver­sion — gefapix­ant, or MK-7264 — to Phase III tri­als for chron­ic cough treat­ment, with high hopes in cre­at­ing a ma­jor new fran­chise pro­gram. But Bel­lus points out in the S-1 fil­ing that in their Phase I tri­al for BLU-5937 they were able to pro­duce pos­i­tive re­sults with­out the taste-al­ter­ing side ef­fects that have marred Mer­ck’s tri­als. In Mer­ck’s lat­est tri­al, over 70% of pa­tients who re­ceived 50 mg ex­pe­ri­enced taste loss or al­ter­ation, com­pared to 5% of pa­tients in Bel­lus’s. In Ju­ly, Bel­lus be­gan its Phase II tri­al for chron­ic cough, which af­fects 26 mil­lion Amer­i­cans.

No ef­fec­tive treat­ment cur­rent­ly ex­ists.

Bel­lus al­so touts their P2X3 in­hibitor as po­ten­tial­ly use­ful against oth­er dis­or­ders re­lat­ed to hy­per­sen­si­tiv­i­ty. In 2020 they will be­gin a Phase II tri­al on eczema. The atopic der­mati­tis field is crowd­ed, but Bel­lus claims 40-50% of pa­tients are dis­sat­is­fied with their treat­ment.

In June Baird an­a­lyst Bri­an Sko­r­ney not­ed that he viewed BLU-5937 as a dif­fer­en­ti­at­ed as­set, say­ing it “may over time prove to be the best-in-class P2X3 an­tag­o­nist.”

Orig­i­nal­ly called Neu­rochem, the com­pa­ny was forced to re­struc­ture in 2008 af­ter their bid to launch their Alzheimer’s drug failed in a large clin­i­cal study. They changed their name and be­gan fo­cus­ing on or­phan drugs, al­though ALZ-801 was
li­censed by Alzheon in 2013.

This will be the sec­ond ma­jor fundrais­er in less than a year for Bel­lus, as it raised $35 mil­lion at $0.95 a share from an eq­ui­ty of­fer­ing in De­cem­ber.

As of June 30, the com­pa­ny had $42.4 mil­lion cash on hand. Bel­lus hopes to even­tu­al­ly sell BLU-5937 at $300-$600 per pa­tient, per month. List­ed in Cana­da, the com­pa­ny’s shares were trad­ing at $2.04.

It’s fi­nal­ly over: Bio­gen, Ei­sai scrap big Alzheimer’s PhI­I­Is af­ter a pre­dictable BACE cat­a­stro­phe rais­es safe­ty fears

Months after analysts and investors called on Biogen and Eisai to scrap their BACE drug for Alzheimer’s and move on in the wake of a string of late-stage failures and rising safety fears, the partners have called it quits. And they said they were dropping the drug — elenbecestat — after the independent monitoring board raised concerns about…safety.

We don’t know exactly what researchers found in this latest catastrophe, but the companies noted in their release that investigators had determined that the drug was flunking the risk/benefit analysis.

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It's not per­fect, but it's a good start: FDA pan­elists large­ly en­dorse Aim­mune's peanut al­ler­gy ther­a­py

Two days after a fairly benign review from FDA staff, an independent panel of experts largely endorsed the efficacy and safety of Aimmune’s peanut allergy therapy, laying the groundwork for approval with a risk evaluation and mitigation strategy (REMS).

Traditionally, peanut allergies are managed by avoidance, but the threat of accidental exposure cannot be nullified. Some allergists have devised a way to dose patients off-label with peanut protein derived from supermarket products to wean them off their allergies. The idea behind Aimmune’s product was to standardize the peanut protein, and track the process of desensitization — so when accidental exposure in the real world invariably occurs, patients are less likely to experience a life-threatening allergic reaction.

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Rit­ter bombs fi­nal PhI­II for sole lac­tose in­tol­er­ance drug — shares plum­met

More than two years ago Ritter Pharmaceuticals managed to find enough silver lining in its Phase IIb/III study — after missing the top-line mark — to propel its lactose intolerance toward a confirmatory trial. But as it turned out, the enthusiasm only set the biotech and its investors up to be sorely disappointed.

This time around there’s little left to salvage. Not only did RP-G28 fail to beat placebo in reducing lactose intolerance symptoms, patients in the treatment group actually averaged a smaller improvement. On a composite score measuring symptoms like abdominal pain, cramping, bloating and gas, patients given the drug had a mean reduction of 3.159 while the placebo cohort saw a 3.420 drop on average (one-sided p-value = 0.0106).

Ear­ly snap­shot of Ad­verum's eye gene ther­a­py sparks con­cern about vi­sion loss

An early-stage update on Adverum Biotechnologies’ intravitreal gene therapy has triggered investor concern, after patients with wet age-related macular degeneration (AMD) saw their vision deteriorate, despite signs that the treatment is improving retinal anatomy.

Adverum, on Wednesday, unveiled 24-week data from the OPTIC trial of its experimental therapy, ADVM-022, in six patients who have been administered with one dose of the therapy. On average, patients in the trial had severe disease with an average of 6.2 anti-VEGF injections in the eight months prior to screening and an average annualized injection frequency of 9.3 injections.

Alex Ar­faei trades his an­a­lyst's post for a new role as biotech VC; Sanofi vet heads to Vi­for

Too often, Alex Arfaei arrived too late. 

An analyst at BMO Capital Markets, he’d meet with biotech or pharmaceutical heads for their IPO or secondary funding and his brain, trained on a biology degree and six years at Merck and Endo, would spring with questions: Why this biomarker? Why this design? Why not this endpoint? Not that he could do anything about it. These execs were coming for clinical money; their decisions had been made and finalized long ago.

Arde­lyx bags its first FDA OK for IBS, set­ting up a show­down with Al­ler­gan, Iron­wood

In the first of what it hopes will be a couple of major regulatory milestones for its new drug, Ardelyx has bagged an FDA approval to market Ibsrela (tenapanor) for irritable bowel syndrome.

The drug’s first application will be for IBS with constipation (IBS-C), inhibiting sodium-hydrogen exchanger NHE3 in the GI tract in such a way as to increase bowel movements and decrease abdominal pain. This comes on the heels of two successful Phase III trials.

Ver­tex deal for Scot­land — no deal for Eng­land

Cystic fibrosis (CF) drug maker Vertex Pharmaceuticals — which is still locked in negotiation with NHS England to endorse the use of its medicines — has successfully negotiated a deal with Scottish authorities.

A month ago, the Scottish Medicines Consortium spurned two of the company’s medicines — Orkambi and Symkevi — citing uncertainty over their long-term efficacy in relation to their cost.

Tony Kulesa, Brian Baynes. Petri

Star founders, in­ves­ti­ga­tors hud­dle around new Boston ac­cel­er­a­tor spot­light­ing young en­tre­pre­neurs

As a widely recognized biotech hub, Boston is undoubtedly one of the best places to start a new company at the frontier of biology and engineering. With a dense network of incubators, venture capitalists and talent, seasoned company founders can have their pick of partners and models launching their latest startups.

But for young, aspiring entrepreneurs, it’s a very different scene.

Big VC firms might hire you to work on their ideas instead of yours, and accelerators may not offer the kind of deep technical expertise and guidance needed to make it in the field.

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From part­ner to knight in shin­ing ar­mor: Cas­tle Creek to buy Fi­bro­cell

In April, Castle Creek swooped in to partner with the embattled gene and cell therapy Fibrocell to shepherd its lead gene therapy for a type of “butterfly” disease into late-stage development. Now, the New Jersey-based dermatology company is acquiring its partner in a deal worth $63.3 million.

Pennsylvania-based Fibrocell last year initiated a review of strategic alternatives, including a sale.