VeraMorph Completes Positive Pre-IND Meeting on Oral Fulvestrant Product, Receives NIH SBIR Phase II Grant, and Names New CEO

• Positive pre-IND meeting with the FDA in regard to the regulatory pathway for approval of the novel oral fulvestrant drug product
• Awarding of a NIH SBIR Phase II grant of $2.1M
• On-boarding Daniel O’Connor as CEO

NORWOOD, Mass.--(BUSINESS WIRE)--Veramorph LLC (VeraMorph) is a specialty pharmaceutical company utilizing its “degradable gel” oral drug delivery platform to develop a pipeline of clinically differentiated orally reformulated drug products. The lead product is the first effective oral formulation of fulvestrant, which is the potential best in class endocrine therapy for estrogen receptor positive (ER+) metastatic breast cancer (mBC) patients without ESR1 gene mutations.

The potential clinical benefit of orally administered fulvestrant is to prolong survival and improve compliance, which is typically correlated with better outcomes, and quality of life for ER+ mBC patients. VeraMorph’s degradable gel technology will enable this outcome by maximizing the drug’s oral bioavailability, which has already demonstrated 20 times higher maximum plasma concentrations in preclinical studies relative to the current injectable product without generating severe adverse events. The initial beneficiaries of oral fulvestrant’s improved exposure are the roughly 70% of ER+ mBC patients that retain a wild-type ESR1 gene. Several oral alternatives to fulvestrant have been approved for patients with ESR1 mutations after progression on a prior endocrine therapy (i.e., in the second line setting). In contrast, fulvestrant efficacy is independent of ESR1 mutation status. With this context, an oral fulvestrant product could capture a substantial portion of the estimated $3B to $6B oral selective estrogen receptor degrader (SERD) therapy market.

VeraMorph plans to develop a dosage strength of oral fulvestrant that achieves an equivalent area under the curve (AUC) over 28 days relative to the approved monthly injectable product. The proposed clinical strategy comprises an initial dose range finding study, a PK bridging study, and an additional safety study given the new route of administration and use of a novel excipient. During a pre-IND meeting, the FDA conveyed openness to the proposed clinical strategy that entails generating clinical data from healthy volunteers. Based on this feedback, VeraMorph expects to submit an NDA in 2029.

Using funds from an SBIR Phase I grant sponsored by the NIH, VeraMorph recently replicated results indicating non-inferior efficacy of oral fulvestrant relative to the approved injectable product in orthotopic and metastatic models of ER+ mBC. Based on these positive results, VeraMorph has received a $2.1M NIH SBIR Phase II grant in order to complete remaining IND-enabling studies on oral fulvestrant as well as PDX studies to generate additional preclinical proof of concept data. These studies will enable VeraMorph to bring oral fulvestrant into the clinic in 2027.

VeraMorph has also recently strengthened its leadership team by adding Daniel O’Connor as the company’s CEO, while founder Doug Godfrin has transitioned to President and CTO. Dan is the former chief strategy officer (CSO) of Eagle Pharmaceuticals, where he spearheaded the development of an FDA New Drug Application (NDA) filing of a novel IM injection of fulvestrant. Dan also contributed to Eagle out-licensing and development efforts for several successful drug products in Eagle’s portfolio, including BENDEKA and PEMFEXY. Dan’s experience and expertise across finance, business development, strategy, and commercialization of drug products will ensure VeraMorph’s success in developing a pipeline of clinically differentiated, orally reformulated drug products using its degradable gel platform.

“I’m thrilled to join VeraMorph to help lead our efforts developing oral drug products meant to improve the patient experience and improve outcomes, starting with breast cancer by focusing on fulvestrant, a product that I have several years of experience with. Our recent engagement with the FDA confirms the enthusiasm for novel oral SERDs within the breast cancer community and the long history of fulvestrant provides confidence in the potential for a superior therapy among this patient population,” said Dan O’Connor, CEO of VeraMorph. “VeraMorph’s pipeline has the opportunity to improve the duration and quality of life of hundreds of thousands of patients across several indications, which is a mission our whole team is dedicated to and motivated by.”

VeraMorph is actively raising a Seed round to finance the upcoming dose ranging study on oral fulvestrant, including the scale-up of production processes for the degradable gel technology and corresponding oral solid dosages to produce clinical trial material. These funds will enable validation of the safety and effectiveness of VeraMorph’s platform technology and the oral fulvestrant product in humans. All of these efforts are aligned with VeraMorph’s mission, which is to improve and prolong the lives of patients across all indications with cost-effective therapies by enabling the full potential of existing therapies.

About VeraMorph:

Veramorph LLC is a science-driven oral drug delivery company dedicated to improving patients' lives by developing a pipeline of clinically superior therapies with its patented oral drug delivery platform. The pipeline spans all indications, maximizing the company’s ability to improve health-related outcomes.