Zacks Small Cap Analysis – RVPH: Preliminary OLE Readout – Digital Digest

By John Vandermosten, CFA

NASDAQ:RVPH

READ THE FULL RVPH RESEARCH REPORT

Open Label Extension Preliminary Readout

Reviva Pharmaceutical Holdings, Inc. (NASDAQ:RVPH) reported preliminary outcomes from its open label extension (OLE) portion of the Section III RECOVER trial. Brilaroxazine confirmed a good long-term security profile and enhancing efficacy over the one-year statement interval. The schizophrenia candidate produced discontinuation charges properly beneath different antipsychotics. The replace supplied each pooled and particular person security and efficacy information. The total information set is anticipated to be out there within the first quarter of 2025.

OLE Background

Following the conclusion of the RECOVER examine, sufferers got the chance to proceed on brilaroxazine to collect long run security and tolerability in an OLE examine. A complete of 435 sufferers had been actively on remedy within the examine throughout the three doses of 15 mg (139), 30 mg (155) and 50 mg (141). 156 topics rolled over from the double-blind portion of the Section III trial and 279 had been new members within the OLE.

The OLE was designed to happen in parallel with RECOVER and consider the long-term security of brilaroxazine. It should consider at the very least 100 topics and might enroll sufferers that had been a part of the RECOVER trial. The examine is listed beneath the identifier NCT05184335 on clinicaltrials.gov in an entry that’s shared with the RECOVER trial. It evaluated versatile doses of brilaroxazine of 15, 30 or 50 mg. Information from the trial might be a part of the brand new drug utility (NDA) bundle that Reviva will undergo the FDA together with anticipated RECOVER-2 information.

OLE First Look

Preliminary outcomes embody efficacy outcomes for 113 sufferers who accomplished a yr of remedy. Security outcomes are for all 435 sufferers enrolled within the OLE, together with these nonetheless actively a part of the trial. Outcomes confirmed dose dependent efficacy. Whole PANSS scores modified by -15.2 (15 mg), -18.6 (30 mg) and -20.8 (50 mg) from baseline to remaining statement at one yr. See exhibit beneath for an illustration of the information.

The common PANSS rating for all dosages was an 18.6-point lower from 71.6 at baseline to 53.0 with a p worth of lower than 0.0001. Optimistic signs for the pooled information declined by 5.2 factors (p<0.0001) and adverse signs fell by 4.5 factors (p<0.0001). If measured from the baseline decided at the beginning of the RECOVER trial, enchancment is PANSS rating of 30 factors or extra was achieved in 87% of sufferers, 40 factors or extra in 65% of sufferers and 50 factors or extra in 34% of sufferers. Notice that the baseline PANSS rating at the start of RECOVER was 99.

Security, Tolerability & Adherence

15.2% of members reported at the very least one treatment-related antagonistic occasion (TRAE), which had been labeled as gentle (12.2%) or reasonable (3%). TRAEs had been transient and had been most steadily weight enhance (3.2%) insomnia (1.8%) and somnolence (1.6%). No drug-related severe antagonistic occasions (SAEs) had been reported and three drug-related SAEs had been reported. No observations of motion problems had been recorded, similar to tardive dyskinesia or acute dystonia which can happen with many first technology and a few second-generation antipsychotics. Discontinuation charges had been favorable in comparison with different accepted antipsychotics reaching 35% on the one-year mark. Primarily based on a evaluate of a number of sources^{[1],[2],[3],[4]}discontinuation for this class ranges anyplace from the mid-40% vary to 70%. For Bristol Myers’ just lately accepted KarXT, discontinuation was 53% after 52 weeks of remedy.

RECOVER-2

Reviva is planning to launch its confirmatory Section III RECOVER-2 trial in 1Q:25. The trial may have an identical design to the RECOVER trial with just a few notable variations. As soon as it begins, we anticipate that the second Section III trial will be capable of enroll at a quicker tempo than the primary as a lot of the bottom work has already been accomplished and the trial managers are skilled. The confirmatory trial will measure endpoints over a 4-week interval and can randomize 450 sufferers 1:1:1 with 30 mg (rather than 15 mg), 50 mg and placebo arms.

On January 9^th2024 the corporate entered right into a start-up settlement with a further contract analysis group to conduct the RECOVER-2 trial. $1.1 million was paid to the group to start out its actions.

An April 15^th press launch introduced that Reviva had come to an settlement with the FDA concerning the content material desired in a brand new drug utility (NDA). The company desires to see two optimistic Section III research exhibiting efficacy at week 4 which are accompanied by security information of at the very least 12 months. It’s going to require a long-term randomized withdrawal examine post-approval to assist upkeep of impact.

Capital Elevate

Reviva had been ready for the proper time to execute its capital elevate and this second arrived following the report of the preliminary OLE information, which supplied a lift for shares and additional proof that brilaroxazine is a compelling product. On the morning of December 16^ththe corporate printed a press launch proposing to supply and promote shares of widespread inventory to fund the RECOVER 2 Section III medical trial. Residents JMP Securities was the bookrunner for the providing.

Later that day, Reviva introduced pricing for the deal which raised $18 million gross. 12 million models had been bought, with every unit consisting of 1 share of widespread fairness, 0.5 collection A warrant and one collection B warrant. The train value for the warrants is $1.50 which have a six month life for the collection A and a 5 yr life for the collection B warrants. Reviva would require as much as an estimated $70 million to finish the RECOVER-2 trial and assist operations till approval and this transaction will begin us alongside this trajectory. The corporate is searching for different sources of capital together with partnerships which will make up the distinction.

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^{[1] Liberman, J.A., et al. Effectiveness of Antipsychotic Medicine in Sufferers with Power Schizophrenia. New England Journal of Drugs. September 2005.}

^{[2] Zhang, C., et al. Charges and predictors of one-year antipsychotic remedy discontinuation in first-episode schizophrenia: Outcomes from an open-label, randomized, “actual world” medical trial. Psychiatry Analysis. March 2019.}

^{[3] Bertolini, F., et al. Evaluating Lengthy-Appearing Antipsychotic Discontinuation Charges Below Peculiar Medical Circumstances: A Survival Evaluation from an Observational, Pragmatic Research. Springer. March 2021.}

^{[4] Seung-Ho, J., et al. Components Affecting Therapy Discontinuation and Therapy Consequence in Sufferers with Schizophrenia in Korea: 10-12 months Observe-Up Research. Psychiatry Investigation. November 2010.}