Aldeyra's Reproxalap Progress And Other News: The Good, Bad And Ugly Of Biopharma
Summary
- Aldeyra progresses with Reproxalap in dry eye disease.
- Kezar reports strong data for SLE drug candidate.
- AbbVie posts positive data for RINVOQ.
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Aldeyra Therapeutics Goes Ahead with Reproxalap for Dry Eye Disease
Aldeyra Therapeutics Inc. (NASDAQ:ALDX) reported that it has struck a deal with the FDA for the use of Reactive Aldehyde Species or RASP for the treating dry eye disease. The agreement has been reached on the basis of meetings, discussions and preliminary written comments. The company stated that it plans to provide further updates on its development plans and submitting NDA obligations for reproxalap in dry eye disease in July 2020.
Aldeyra is currently working on reproxalap, which is its first in class RASP inhibitor. In a Phase 2a study, the drug candidate showed reduction in tear RASP level after 28 days of treatment. During in vitro studies, the drug candidate was able to eliminate RASP in 60 to 90 minutes of administering equimolar concentrations. Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra said, “Representing the first novel objective sign for the treatment in dry eye disease in over a decade, RASP are critical mediators of inflammation. We look forward to continuing to advance reproxalap, our novel RASP inhibitor in Phase 3 clinical trials for dry eye disease and allergic conjunctivitis, toward NDA filing.”
RASP are pre-cytokine pro-inflammatory mediators which are found to be in the higher amount in the tears of patients suffering from dry eye disease. These also correlate with dry eye disease signs and symptoms. The drug candidate is applied topically to the eye and is believed to have more than 500-fold than tear RASP levels. Reproxalap has also shown consistent clinically relevant and statistically significant activity in dry eye disease, allergic conjunctivitis, and several other types of ocular inflammation in various Phase 2 and Phase 3 clinical trials.
Reproxalap is currently undergoing Phase 3 INVIGORATE trial and the results are expected to be out in the first half of 2021. The trial is assessing the potential of the drug candidate for treating allergic conjunctivitis. The drug candidate has already shown clinically relevant improvement from baseline in two well-controlled clinical trials. These clinical trials are Part 1 of the Phase 3 RENEW Trial and a Phase 2 formulation trial. The former was announced late last year while the latter was announced earlier this year.
The Part 1 of its adaptive Phase 3 RENEW Trial showed that the drug candidate has the potential to become the first topical dry eye disease treatment to show statistically significant improvement as soon as one week after the start of the treatment. The RENEW Trial is a two-part, multi-center, randomized, vehicle-controlled, double-masked, parallel-group Phase 3 trial. It sought to assess the potential of 0.25% topical ocular reproxalap compared to vehicle in patients suffering from moderate to severe dry eye disease.
The Part 1 had 422 patients which were randomized equally to receive either four-times-daily reproxalap or vehicle for twelve weeks for the constant dosing group or four-times-daily reproxalap or vehicle for four weeks, followed by twice-daily reproxalap or vehicle for eight weeks for the induction-maintenance dosing group.
Kezar Reports Positive Data for SLE Drug Candidate
Kezar Life Sciences (KZR) provided updated data from the first of its Phase 1b/2 clinical trial MISSION. The trial aimed to test KZR-616 in patients suffering from systemic lupus erythematosus with and without nephritis or kidney inflammation. The data showed favorable safety and tolerability profile, with transient injection site reactions as the most common treatment related adverse events.
The data demonstrated overall improvements across seven measures of disease activity. Two of two patients suffering from lupus nephritis showed a greater than 50 percent improvement in proteinuria, which is a biomarker of disease severity. Noreen Henig, MD, Kezar’s Chief Medical Officer said, “Most strikingly, there are early and strong signs of modification of SLE disease activity, including a reduction in symptoms and biomarkers. Given the encouraging exploratory efficacy data, we are evaluating opportunities to quickly bring KZR-616 to patients with a wide array of severe autoimmune diseases.”
The company reported enrolling 39 SLE patients across five dose cohorts for the Ph1b portion of MISSION as of the May 4, 2020 data cutoff. The trial will evaluate 45 mg and step-up dosing to 60 mg weekly for 13 weeks. The follow ups will be done to week 25 and the patients will be kept on stable background treatment. The primary objective of the Ph1b portion of MISSION is to evaluate safety and tolerability of the drug candidate. Secondary objectives include evaluation of pharmacokinetics (PK) and pharmacodynamics (PD) and the selection of dose levels for the Phase 2 trials.
KZR-616 is a novel, first-in-class, selective immunoproteasome inhibitor. The drug candidate has potential to treat a wide range of autoimmune diseases. The safety and tolerability profile is well established from the data collected from two Phase 1a studies and the Phase 1b clinical trial. It is currently undergoing Phase 2 trials for different indications such as autoimmune hemolytic anemia, immune thrombocytopenia, Lupus Nephritis and dermatomyositis and polymyositis.
AbbVie Provides Positive Update for RINVOQ
AbbVie (ABBV) announced that its RINVOQ met the primary endpoint for its Phase 3 SELECT-CHOIXE clinical trial. It also met the key secondary endpoints. The study aimed to assess the potential of RINVOQ in adult patients suffering from moderate to severe active rheumatoid arthritis and prior inadequate response or intolerance to biologic disease-modifying anti-rheumatic drugs.
SELECT-CHOICE formed the sixth and final Phase 3 study from the robust SELECT clinical trial program pertaining Rheumatoid Arthritis. RINVOQ met both the primary endpoint of non-inferiority and secondary endpoint of superiority. These endpoints were satisfied with a change from baseline in DAS28-CRP at week 12 of -2.52 compared to -2.00 in patients treated with ORENCIA.
30 percent of patients given RINVOQ achieved clinical remission at week 12 in comparison to only 13 percent of the patients on ORENCIA hitting the mark. Michael Severino, M.D., vice chairman and president, AbbVie said, "We are pleased with the results as they add to our growing body of evidence that RINVOQ may offer more adult patients with rheumatoid arthritis a better chance at achieving clinical remission, including those who have already failed a prior biologic."
RINVOQ group also showed better ACR20/50/70 responses. The safety profile of the drug candidate is found to be consistent with that observed in previously reported studies in rheumatoid arthritis. 3.3 percent of the patients in the RINVOQ group reported serious adverse events in comparison to 1.6 percent of patients in ORENCIA group claiming the same through week 24. The RINVOQ group also reported 23 instances of hepatic disorder mainly liver enzyme elevations. All these events were deemed non serious.
RINVOQ is a selective and reversible JAK inhibitor. It has shown potential to treat a wide range of immune mediated inflammatory ailments. The drug candidate is already FDA approved for treating moderate to severe active rheumatoid arthritis in adult patients who showed an inadequate response or intolerance to methotrexate.
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Comments (10)
Reproxalap uses Captisol which is an excipient made by Ligand Pharmaceuticals and used also in remdesivir which is the Covid treatment produced by Gilead. Ligand recently announced in a letter that it is scaling up production of Captisol fro a capacity of 60 metric tons per annum to 500 metric tons per annum. Drug development takes time but reproxolap looks like it will have a role in dry eye disease and allergic conjunctivitis to me.
Could get fast tracked don`t forget! JMO & no position yet as there are a lot of players in the field.