Clinical Catch-Up: Good News for BioVie, Regeneron, Relay and More

Clinical trial

The week has seen a series of significant wins from BioVie, Regeneron, Relay Therapeutics, Oxford University, Vistagen and Palatin. BioSpace summarizes the key details below.

September 8

Regeneron Pharmaceuticals

Regeneron Pharmaceuticals announced that its investigational drug, aflibercept 8 mg, met the primary endpoints in both the PHOTON and PULSAR trials for diabetic macular edema and wet age-related macular degeneration (wAMD).

Results from 12-week and 16-week dosing intervals up to week 48 showed 91% and 89% of DME patients were initiated and maintained, while 79% and 77% of participants with wAMD experienced the same. Aflibercept 8 mg's safety profile was also consistent with previous studies on the Eylea (aflibercept) injection 2 mg version.

Regeneron and partner Bayer AG plan to submit these findings to regulatory authorities worldwide for approval. If approved, the patient-friendly 8 mg dose can potentially establish Eylea as the standard of care for the said ophthalmic disorders versus the current popular contender Vabysmo (faricimab) by Roche. Vabysmo requires patients to receive ten injections over two years, while the 2 mg Eylea drug requires 15 doses.  

Regeneron has the exclusive rights to Eylea (2 mg) and aflibercept 8 mg in the United States, while Bayer maintains exclusivity outside the country.

VistaGen Therapeutics

After pausing enrollment for the Phase III PALISADE-2 trial on anxiety drug candidate PH94B in July, VistaGen Therapeutics announced that it is continuing the full enrollment of 208 participants. The decision was made shortly after receiving a go-ahead from independent biostatisticians who evaluated unblinded data from the study.

PH94B is being investigated as an acute treatment of anxiety in adults diagnosed with Social Anxiety Disorder. Although enrollment was cut short in July based on topline results from PALISADE-1, the latest directive will have PALISADE-2 proceeding without changing the study size.

Vistagen expects to release topline data from the latest trial by the first half of 2023. According to chief executive officer Shawn Singh, the company also plans to meet with the FDA by the end of the year to discuss plans for further Phase III studies involving PH94B in SAD.

Palatin Technologies

Palatin Technologies has begun the Phase II clinical trial of an investigative drug for ulcerative colitis. PL8177 is a melanocortin-1 receptor agonist designed to be given orally to adult patients with active UC. The Phase I study demonstrated the drug's capacity for sustained delivery to the colon's lumen without systemic exposure. The goal of Phase II is to establish PL8177's tolerability and safety. Around 28 adults will be enrolled across 22 sites, with the interim assessment expected to happen by the first quarter of 2023. If everything moves as scheduled, topline data could be available by the second quarter of 2023.

September 7


BioVie shared topline results from the Phase II clinical trial of NE3107 for the treatment of Alzheimer's Disease.

The investigator-initiated study, led by principal investigator Dr. Sheldon Jordan, explored the link between NE3107's role in neuroinflammation and insulin resistance to the biomarkers historically utilized in AD research. The goal was to evaluate NE3107 in real-world clinical conditions.

Initial results showed improved Mini-Mental State Examination (MMSE) scores in 62% of the 23 participants treated with 20 mg of NE3107 twice daily for three months. Those diagnosed with mild cognitive impairment to mild AD, or 17 patients, demonstrated a bigger change at 82%. There were no treatment-related adverse effects reported.

The topline results represent the first detailed data linking NE3107's role in AD, according to Cuong V. Do, the president and chief executive officer of BioVie. Do added that Jordan's sponsored trial will be instrumental to future research efforts on the impact of NE3107 on traditional Alzheimer's biomarkers.

Final data will be presented at the November Clinical Trial in Alzheimer's Disease annual conference in San Francisco.

Relay Therapeutics

Relay Therapeutics published positive results from its Phase I/II ReFocus trial on bile duct cancer drug candidate RLY-4008 in patients with FGFR2-altered cholangiocarcinoma.

The study, published by the European Society for Medical Oncology, showed the drug to be potent across all dose levels ranging from 20 to 200 mg twice or four times a day, particularly among participants who received 70 mg four times a day, achieving an overall response rate of 88%. One patient from this dose group reportedly had a near-complete response and subsequent tumor resection with curative intent. The trial is ongoing.

The University of Oxford

University of Oxford scientists may have developed a new malaria booster vaccine that challenges the current GlaxoSmithKline-produced vaccine that the World Health Organization approved for use in Africa in 2021.

In a study published in The Lancet: Infectious Diseases, professor Adrian Hill and his team evaluated the immunogenicity and efficacy of R21/Matrix-M in children with malaria in Burkina Faso. They found an 80% efficacy in the high-dose adjuvant group and 71% in the low-dose cohorts. The participants were given the booster one year after the primary three-dose regimen. Among the high-dose recipients, efficacy against multiple malaria episodes reached 78%.

The Phase I/IIb trial has already progressed to a fully enrolled Phase III. The scientists aim to get regulatory approval for R21/Matrix-M in 2023.

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