NASDAQ:BIOR
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Biora Therapeutics, Inc. (NASDAQ:BIOR) reported select results from its BT-600 trial on July 1st confirming and expanding upon the favorable findings in the interim update provided in April. All pharmacokinetic endpoints were achieved and drug delivery and absorption in the colon, including distal portions, was biopsy confirmed. NaviCap devices performed as intended and were well tolerated, producing no safety signals. The results support the advance of BT-600 into a Phase Ib clinical trial in patients with ulcerative colitis (UC).
April Interim Results
As a prelude to these topline results, interim data back in April summarized data from the single-ascending dose (SAD) portion which evaluated the tolerability and pharmacokinetics of BT-600 at 5 and 10 mg. Tofacitinib was first detected in plasma at ~6 hours after administration, which is consistent with colonic delivery as opposed to absorption in the upper gastrointestinal tract. The mean time to reach maximum concentration (Tmax) was 8 to 10 hours following drug administration, versus 30 to 60 minutes for conventional oral tofacitinib. Tofacitinib was present in fecal samples of all subjects, further confirming delivery of the drug in the colon.
Clinical Trial Results
Topline results from both the SAD and multiple ascending dose (MAD) portions of the BT-600 Phase I trial were reported last week showing evidence of systemic absorption of tofacitinib at six hours consistent with NaviCap’s expected delivery profile. NaviCap maximum blood serum levels of tofacitinib occurred at eight to ten hours compared to the 30 minutes observed in other conventional oral tofacitinib trials. Systemic drug exposure for BT-600 was from one quarter to one third the levels of those observed with conventional oral tofacitinib.
The clinical trial protocol required biopsy of treated colonic tissue including the distal colon to produce evidence of drug exposure. Biopsy results showed evidence of drug delivery throughout the colon and at common sites of ulcerative colitis-related inflammation and ulcers. In the multiple NaviCap deliveries to the 48 healthy participants in the trial, 100% of the SAD subjects and 98% of the MAD subjects had confirmed NaviCap device delivery.
In conjunction with the report of BT-600 topline results, Biora announced that it will host a key opinion leader (KOL) event on July 17th, 2024 at 2:00 pm Eastern Time. The live webcast can be accessed here:
➢ https://lifescievents.com/event/biora/
Poster Presentations
Since our first quarter results update in mid-May, and in addition to BT-600 topline, Biora has also participated in two conferences including Digestive Disease Week (DDW) on May 19th in Washington D.C. and the Next Gen Peptide Formulation and Delivery Summit on June 19th in Boston.
Digestive Disease Week
The poster presentation at DDW was entitled Results of Human Device Function Studies for the NaviCap Targeted Oral Delivery Platform in healthy volunteers and patients with UC. The associated press release summarized the functionality and safety of NaviCap as explained in four clinical studies. Biora’s Chief Medical Officer Ariella Kelman, MD, noted that the NaviCap device was well-tolerated in 81 administrations to 47 participants, releasing its payload in the colon, regardless of variable GI transit time, the level of inflammation, or the presence of blood in stool. Biora asserts that NaviCap’s ability to function across variable GI conditions and eating schedules illustrates its potential to deliver therapeutics locally to the colon of patients with UC.
Conclusions from the poster noted that the NaviCap platform’s ability to function across variable GI pH, motility, and eating schedules illustrates the device’s potential capability to deliver therapeutics locally to the colon of patients with UC and that localized delivery could potentially improve efficacy while minimizing systemic exposure and toxicity that is associated with systemic drug delivery.
Next Gen Peptide Formulation and Delivery Summit
The Peptide Summit, which took place from June 18 to 20 in Boston included a presentation by Biora entitled Empowering Peptide Self Administration with Needle-Free Smart Capsules. It was presented in the afternoon of June 19 by Sharat Singh, PhD, Head of Research, Biora Therapeutics. Dr. Singh also joined a panel presentation at the event titled “Uncovering Innovations in Peptide Drug Delivery & Formulation for Improved Bioavailability,” alongside representatives from Eli Lilly, Merck, and Novo Nordisk. A press release detailing Biora’s participation in the event was published on June 11.
BT-600 Program Background
IND Clearance for BT-600
Following an investigational new drug (IND) submission in September 2023 for the NaviCap BT-600 program, the FDA responded with questions in late October. The data the agency sought for the clinical trial evaluating the safety of tofacitinib delivery to the small intestine for ulcerative colitis (UC) was readily available and resubmitted to the agency a week later. On November 30, the FDA cleared Biora’s IND application for BT-600, allowing the study to begin. An announcement of the trial’s initiation was made in January. The Phase I was designed to directly deliver tofacitinib to the colon for the treatment of moderate to severe UC. Data from the study centers on the pharmacokinetic and pharmacodynamic effects of BT-600. In late February, Biora announced that the single ascending dose (SAD) cohorts had been completed and that the multiple ascending dose (MAD) cohorts would begin. The MAD portion is designed to enroll 24 participants to receive BT-600 tofacitinib at 5 and 10 mg or placebo. By the end of April 2024, the MAD cohorts had been completed and management guided towards a late June report of full study data. Topline data for both the SAD and MAD portions was reported on July 1st.
Milestones
➢ Achieve >25% bioavailability in AstraZeneca collaboration – January 2024
➢ Settlement of IPO litigation – March 2024
➢ Nasdaq notification letter indication bid price below compliance level – May 2024
➢ NaviCap Clinical Data presentation at Digestive Disease Week – May 2024
➢ BT-600 Phase I final data assessment – 2Q:24
➢ Animal study data for BioJet presented at the Next Gen Peptide Summit – June 2024
➢ Report of topline data for SAD and MAD portions of BT-600 – July 2024
➢ FDA meetings for future BT-600 trial design – 2024
➢ Begin Phase Ib in Active UC for NaviCap – 2H:24
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