Med­i­ci­No­va flops in PhII metham­phet­a­mine de­pen­dence tri­al, stock slips

San Diego drug­mak­er Med­i­ci­No­va has flunked a mid-stage tri­al test­ing its lead drug can­di­date against metham­phet­a­mine de­pen­dence, send­ing the com­pa­ny’s stock quick­ly south in pre-mar­ket trad­ing.

Yuichi Iwa­ki

The com­pa­ny an­nounced Thurs­day that its Phase II clin­i­cal tri­al as­sess­ing MN-166, a drug called ibudi­last, failed to achieve the study’s pri­ma­ry end­point: metham­phet­a­mine ab­sti­nence dur­ing the last weeks of treat­ment.

Med­i­ci­No­va is hop­ing to get a lot out of ibudi­last, test­ing the drug in mul­ti­ple neu­rode­gen­er­a­tive and sub­stance de­pen­dence in­di­ca­tions, in­clud­ing MS, ALS, and opi­oid de­pen­dence. The drug has been around for a long time treat­ing post-stroke com­pli­ca­tions and bronchial asth­ma, and has been on sold in Japan and Ko­rea since 1989. Med­i­ci­No­va says ibudlilast’s an­ti-neu­roin­flam­ma­to­ry and neu­ro­pro­tec­tive ac­tions back up the com­pa­ny’s rea­son­ing for the drug’s use in neu­rode­gen­er­a­tive dis­or­ders and sub­stance abuse. In ad­di­tion to this flopped metham­phet­a­mine de­pen­dence tri­al, Med­i­ci­No­va has five oth­er on­go­ing Phase II tri­als of the drug.

Med­i­ci­No­va’s stock $MNOV was down 15% in pre­mar­ket trad­ing as of press time, trad­ing for $10.17 per share.

Med­i­ci­No­va’s pres­i­dent and CEO Yuichi Iwa­ki had this to say in a state­ment:

We will con­duct fur­ther analy­ses of the da­ta with UCLA re­searchers, which will help us to bet­ter un­der­stand how to op­ti­mize study de­sign and set­ting for any fu­ture clin­i­cal tri­als in sub­stance de­pen­dence.  We will dis­cuss the re­sults with NIH/NI­DA, who pro­vid­ed the fund­ing for this tri­al, the opi­oid de­pen­dence tri­als and the al­co­hol de­pen­dence tri­al.  We plan to meet with FDA af­ter we have da­ta from the on­go­ing study of MN-166 in metham­phet­a­mine use dis­or­der at Ore­gon Health & Sci­ence Uni­ver­si­ty.

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.

Lisa M. DeAngelis, MSKCC

MSK picks brain can­cer ex­pert Lisa DeAn­ge­lis as its next CMO — fol­low­ing José Basel­ga’s con­tro­ver­sial ex­it

It’s official. Memorial Sloan Kettering has picked a brain cancer expert as its new physician-in-chief and CMO, replacing José Baselga, who left under a cloud after being singled out by The New York Times and ProPublica for failing to properly air his lucrative industry ties.

His replacement, who now will be in charge of MSK’s cutting-edge research work as well as the cancer care delivered by hundreds of practitioners, is Lisa M. DeAngelis. DeAngelis had been chair of the neurology department and co-founder of MSK’s brain tumor center and was moved in to the acting CMO role in the wake of Baselga’s departure.

Penn team adapts CAR-T tech, reengi­neer­ing mouse cells to treat car­diac fi­bro­sis

After establishing itself as one of the pioneer research centers in the world for CAR-T cancer therapies, creating new attack vehicles to eradicate cancer cells, a team at Penn Medicine has begun the tricky transition of using the basic technology for heart repair work.

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