JPM 2025 | Biohaven's Innovative Therapy BHV-1400 Shows Exceptional Potential in Phase I Clinical Trials for IgA Nephropathy

January 14, 2025 – At the 43rd J.P. Morgan Healthcare Conference, Biohaven Ltd. presented positive data on BHV-1400, a next-generation potential treatment for IgA nephropathy (IgAN).

BHV-1400 is a second-generation TRAP? degrader from the company’s proprietary MoDE? platform. This therapy is capable of rapidly, deeply, and selectively reducing galactose-deficient IgA1 (Gd-IgA1).

The TRAP molecule heralds a new era of immunomodulatory treatment by targeting and removing pathogenic proteins while preserving the normal function of a healthy immune system.

The rapid degradation of Gd-IgA1 is the key advantage of BHV-1400. Data from the first and lowest dose cohort in the trial showed a clear distinction between BHV-1400 and competitors in the IgA nephropathy field. Gd-IgA1 levels dropped rapidly within four hours while preserving host immunoglobulins, including IgG, IgA, IgE, and IgM.

In Phase I clinical trials, researchers observed rapid and deep reductions in Gd-IgA1 levels after a single 125 mg dose:

1. First dose (125 mg): Median Gd-IgA1 reduction of 60% within just 4 hours.
2. Maximum reduction: Over 70% within 8 hours, with the effect persisting for several days after a single dose.

The safety profile of BHV-1400 was favorable, with no significant toxicity observed during the Phase I trial:

1. No dose-limiting toxicity (DLT) was observed.
2. No clinically significant changes in white blood cell counts or immunoglobulin levels (IgG, IgA, IgE, IgM).
3. No abnormalities in liver function, albumin, cholesterol, or other key parameters.

Biohaven stated in its press release: "The selective and rapid reduction of Gd-IgA1 by BHV-1400 represents a second-generation treatment approach for IgAN. This method may allow effective disease control while reducing acute or long-term safety risks associated with B cell-targeted therapies, complement inhibitors, or broad immunosuppression."

Biohaven plans to pursue an accelerated path to Phase III clinical trials upon completing Phase I studies.

IgA nephropathy is a rare, chronic kidney disease affecting young and middle-aged adults. It is caused by Gd-IgA1 and leads to kidney failure in up to 40% of patients within 10–20 years. According to Frost & Sullivan, the global market for IgA nephropathy treatment drugs is growing rapidly, projected to increase from $567 million in 2020 to $1.196 billion in 2025, at a compound annual growth rate (CAGR) of 16.1%.

In China, the IgA nephropathy treatment drug market is expected to grow from $37 million in 2020 to $109 million in 2025, with a CAGR of 24.6%.