Immunic Positive Data, And Other News: The Good, Bad And Ugly Of Biopharma (NASDAQ:IMUX)

Immunic announced positive top line data for IMU-838

Immunic Inc. (IMUX) announced top line data from Phase EMPhASIS trial of lead drug candidate, IMU-838, aimed at patients with relapsing-remitting multiple sclerosis or RRMS. The company reported that the trial achieved all its primary and secondary endpoints. The drug candidate was also observed to be well-tolerated and safe, in line with the prior data.

The phase 2 EMPhASIS trial was an international, multicenter, double-blind study. This randomized, placebo-controlled, parallel group study aims to evaluate the efficacy and safety of IMU-838 in patients with RRMS. It enrolled 210 patients across 36 centers spread in four European countries. Out of these, 209 patients were administered minimum one dose of IMU-838 or placebo. 197 patients completed the blinded 24-week treatment period.

The trial showed a statistically significant reduction in the cumulative number of combined unique active MRI lesions up to week 24 in patients receiving 45mg of IMU-838 once daily, by 62 percent, in comparison to placebo, thus fulfilling the primary endpoint. Andreas Muehler of Immunic said, “Patients in the EMPhASIS trial exhibited robust responses across all study endpoints included in the top-line analysis. In addition to showing consistent activity by IMU-838 in RRMS using different measures, the study data also supports the previously observed favorable safety and tolerability profile of IMU-838 in RRMS patients.”

The trial met its key secondary endpoint by producing a statistically significant reduction in the cumulative number of CUA MRI lesions for the 30mg once daily dose by 70% in comparison to placebo. Some of its other secondary endpoints are based on different MRI parameters as well as on clinical endpoints including relapse events. The company stated that due to the study’s scope, it was not deemed appropriate to carry out full statistical analysis of these endpoints.

42.9% of IMU-838-treated patients reported treatment-emergent adverse events while in placebo group, 43.5 percent complained about the same. Serious treatment-emergent adverse events were reported by 3 patients out of 140 patients on IMU-838. For placebo group, 1 patient out of 69 patients reported such incidents. There was no increase in liver or renal events for the IMU-838 treatment arms versus placebo.

Immunic further added that patients in the trial showed robust responses for all study endpoints. The data also corroborated the safety and tolerability profile of the drug candidate. The company is now designing its future plans regarding the treatment.

IMU-838 is an orally available, selective immune modulator. It works by controlling the intracellular metabolism of activated immune cells. It acts on activated T and B cells while minimally impacting other immune cells. DHODH inhibitors such as IMU-838 generally possess a host based antiviral impact.

Immunic Inc. is a clinical stage company and is mainly aimed at developing therapies for chronic inflammatory and autoimmune ailments such as ulcerative colitis, psoriasis, Crohn’s disease and relapsing-remitting multiple sclerosis. The company is currently working on developing three small molecule products including IMU-838. Its other lead products are IMU-935 and IMU-856. The former is an inverse agonist of RORγt while the latter targets the restoration of the intestinal barrier function.

Catalyst Pharma gets stung in FDA lawsuit

Catalyst Pharmaceuticals’ (CPRX) stock stumbled as the company was delivered an adverse ruling in its lawsuit against the FDA. The lawsuit in the question pertains to Firdapse. The company had sued the FDA in June 2019 pursuant to the approval of Ruzurgi for children, allowing it to be prescribed “off label” for adults as well. Ruzurgi has been developed by Jacobus Pharmaceutical Company.

In the latest development, a magistrate judge made a recommendation to the district court judge that the FDA and Jacobus are granted motions for summary judgement while Catalyst’s motion is denied for summary judgment. The company is currently reviewing the decision and is of the opinion that the decision is incorrect as a matter of law. Catalyst plans to pursue the course further with the District Judge.

Catalyst maintains that the recommendation does not change the fact that Jacobus is not allowed under relevant law to market its product to adult patients of LEMS in the United States. Patrick J. McEnany, the Company’s Chairman and CEO, added, “We are obviously very disappointed with the Magistrate Judge’s recommendation, which we believe is contrary to the plain language of the Orphan Drug Act.” The company further stated that the recommendation effectively eliminates the exclusivity benefits bestowed under the Orphan Drug Act.

Catalyst is currently weighing its options to ensure that it protects Firdapse’s exclusivity under the Orphan Drug Act. Catalyst Pharmaceuticals is a commercial-stage biopharmaceutical company. Its main focus is on developing therapies for chronic neurological and neuromuscular diseases such as Lambert-Eaton myasthenic syndrome. The company’s new drug application for Firdapse 10mg tablets for treating adult LEMS patients was approved by the FDA in November 2018. The drug candidate was earlier granted breakthrough therapy designation and orphan drug designation by the FDA. The latter designation offers a seven-year period of market exclusivity.

Arcutis provides positive update for roflumilast cream

Arcutis Biotherapeutics Inc. (ARQT) reported positive results from its investigational drug topical roflumilast cream trial. The cream is being evaluated for treating chronic plaque psoriasis. The data showed the cream to be safe and highly effective in two different doses of 0.5 percent and 0.15 percent. The drug candidate has the potential to become once-daily topical therapy for chronic plaque psoriasis.

The Phase 1/2a study enrolled a single-dose, open-label Phase 1 cohort and a 28-day, double-blinded Phase 2a cohort. The enrolled participants had the condition for more than 6 months and had 5 percent or more body surface area involved. The outcomes for the trial included safety and efficacy. The safety factor was measured through adverse events while efficacy was tested through percentage change in the product of Target Plaque Severity Score or TPSS and Target Plaque Area or TPA at week 4.

The adverse events across both the cohorts were similar between vehicle and active arms. No patient was reported to have discontinued treatment owing to adverse events. Frank Watanabe of Arcutis said, “We believe that topical roflumilast has the potential to deliver the efficacy that enables meaningful symptomatic improvement and a safety and tolerability profile that supports chronic use and the ability to use in all body areas.”

Topical Roflumilast Cream is coded as ARQ-151 and it is a once-daily topical cream formulation. It mainly consists of roflumilast which is a PDE4 inhibitor and is being developed by the company for treating plaque psoriasis, including intertriginous psoriasis, and atopic dermatitis. Roflumilast is already approved by the FDA for systemic treatment for curtailing the risk of exacerbation of chronic obstructive pulmonary disease.

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Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

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